Research · End-stage options

End-stage options: fusion, replacement, total talus

Fusion, ankle replacement and total talus replacement. Revision hazard doubles under age 55, and the FDA has told surgeons to prefer other implants over one of them. The far end, not the plan.

Total Ankle Arthroplasty (TAA) vs. Ankle Fusion

Meta-Analysis Summary (4,312 TAA, 1,091 fusion procedures)

FDA Safety Communication: One Ankle Replacement Implant Is Failing More Than Expected

→ “Ankle replacement” is not one product. In June 2026 the FDA told doctors to prefer other options over one specific implant, because long-term registry data showed it failing at roughly twice the rate of its competitors. This is not a recall, and it is not about ankle replacement in general.

Recorded July 28, 2026. The FDA notice itself is dated June 3, 2026 — outside this week's window, but it had never been captured on this page. The FDA issued an update to an earlier safety communication about the Hintermann Series H3 Total Ankle Replacement (DT MedTech LLC, previously sold as Hintegra by NewDeal/Integra), approved in the US in 2019 with mandated post-approval studies [246]. Three independent data sources:

FDA's recommendation to surgeons is to “consider using an available alternative treatment option where possible.” The device has not been recalled and remains on the market. For anyone already implanted and doing well, the FDA explicitly does not recommend removal — only continued follow-up, with CT rather than X-ray if a fractured plastic component is suspected, because the finding can be subtle.

Why this is on this page. Total ankle replacement sits at the far end of the decision tree here and is not close to being on the table. It matters for two reasons anyway. First, it is a concrete reminder that implant choice within a category can matter as much as the choice between categories — a nearly two-fold difference in revision risk between devices dwarfs most of the differences being weighed between procedures. Second, the failure mode was only visible in fifteen-year registry data, which is longer than most of the follow-up cited anywhere else on this page. For a patient in his thirties, that is the relevant timescale, and it is a reason to ask specifically which implant a surgeon uses and what its registry record looks like — not merely whether replacement or fusion is better in general.

2024-2025 TAA Advances

Recent studies show significant improvements in newer implant designs [86]:

TAA in Young Patients (<50-55 years)

93.5%
Survival (<50 yrs) [56]
94%
Survival (<55 yrs) [57]
1.8-2.65x
Higher revision risk [56]
91.8%
10-yr implant survival [58]

Third-generation designs show improved results vs older prostheses. At medium-term, TAA is at least as effective in patients <50 as in older patients [59].

2025 National Registry Data

Recent national registry analyses provide large-scale outcome data [88]:

2026 Landmark: 25-Year, 41,000-Patient Registry (England)

The largest-ever comparison of TAR vs ankle fusion (10,335 TARs vs 30,704 fusions, 1998-2023) [172]:

2.73x
TAR revision hazard vs fusion
35%
TAR 25-year intervention-free survival
69.2%
Fusion 25-year intervention-free survival

→ This registry endpoint was later adjacent-joint fusion. It does not exclude adjacent-joint degeneration, pain, or other symptoms after ankle fusion.

Ankle Fusion Long-Term Outcomes

2024-2025 Arthrodesis Techniques

Newer fusion techniques show improved outcomes [89]:

Conversion: Fusion to TAA

For painful fusions, conversion to TAA is possible [62]:

Key point: All doctors agreed ankle fusion should be avoided for someone young with good ROM. Cleveland Clinic noted TAA would be a later escalation step.

Total Talar Replacement (TTR)

Total talar replacement is a newer procedure where the entire talus bone is removed and replaced with a custom 3D-printed prosthetic implant. Because the talus has no direct muscle/tendon attachments and limited blood supply, it is uniquely suitable for full bone replacement.

→ Unlike total ankle replacement (TAR) which replaces the joint surfaces of both the tibia and talus, TTR replaces only the talus bone itself. TTR is indicated when the talus is too damaged for cartilage repair (AVN, collapse, large cystic defects unresponsive to treatment).

The Procedure

FDA Approvals

Device-Specific Indications and Contraindications

→ “Total talar replacement” is not one product — the FDA labeling differs by implant, and so does who actually qualifies.

Outcomes Data

Systematic review of 22 studies (191 patients, 196 tali) [162]:

94.5%
Implant survivorship [159]
69.6%
Significant functional improvement [162]
0.1%
Cumulative implant failure rate [162]
8.2 → 2.1
VAS pain score (titanium series) [163]

Additional clinical results:

TTR vs. Ankle Fusion vs. TAR

Longevity: The "Every 10 Years" Question

Dr. Salk stated the implant would need replacing approximately every 10 years. What the data shows:

→ The "every ~10 years" figure should be treated as a surgeon estimate or extrapolation, not a proven lifespan for current patient-specific TTR implants. The only genuine long-term follow-up is the Japanese ceramic series (Morita 2022, 10+ years), and modern 3D-printed cobalt-chrome and titanium designs still have only short-term to mid-term follow-up.

Risks and Complications

TTR is encouraging, but it is not a “drop-in replacement bone” with trivial downside. The specific rates from the two largest modern cohorts are sobering:

2026 Regulatory Status Updates

Two practical regulatory updates that materially affect how TTR should be interpreted today:

→ Translation: the “broad OLT-indication” TTR option in the U.S. currently rests on a single active device (restor3d) whose post-market evidence base is barely off the ground, while the other recently approved U.S. talar replacement (4WEB) may not be commercially available at all.

Evidence Gap for Raymond’s Exact Situation

The published TTR evidence does not match Raymond’s case especially well:

There is no strong peer-reviewed TTR series specifically for a failing focal talar allograft/OLT with otherwise preserved joint space. Direct evidence for Raymond’s exact use case is still thin.

Added August 3, 2026 — what the FDA adverse-event database shows, and it is the clearest argument on this page

→ The published series report how patients did. The adverse-event reports show what happens when it goes wrong — and the pattern is that each revision costs another joint.

A report filed with the FDA in June 2026 describes the escalation ladder run to its end. Quoted verbatim: “The patient had a talus fracture nonunion with previous talar replacement with deformity and advancing arthrosis. Patient has had two revisions from a total talus to a total talus with total ankle and subtalar fusion. Now, physician is revising again with spherical-bottom talus with total ankle and STJ and TN fusion” [322]. That is a fourth talus construct, and the sequence is the point: talus alone, then talus plus total ankle plus subtalar fusion, now adding talonavicular fusion. The hindfoot is being spent one joint per revision.

Two further reports, both filed in June 2026, describe custom talus implants explanted at roughly six and six-and-a-half years. One: “joints around the implant eroded causing the implant to shift out of position.” The other: the patient “presented with arthritis in the subtalar and talo-navicular joints” [323]. Degeneration of those neighbouring joints is precisely what the device labels list as a contraindication to implanting in the first place — and these reports show the implant producing it. Corrected August 4, 2026: this passage previously described that six-year interval as close to how long this patient’s own 2012 allograft lasted. It is not — the allograft ran from October 2012 to March 2025, about twelve and a half years. These implants were explanted in roughly half that time, which makes the comparison less reassuring rather than more. A third 2026 report records explant at three months for wound-closure failure, replaced with an antibiotic spacer; and a cluster of five post-approval study reports includes complex regional pain syndrome at ten months and two anterior wound dehiscences within a month of surgery.

State the limits honestly. There are only eighteen such reports in total across all years, every manufacturer concluded that no device defect was involved, and adverse-event counts cannot be converted into rates without denominators that do not exist for humanitarian-exemption devices. One of these reports describes an event from February 2023 filed forty months later. None of this says the operation usually fails. What it does is put a mechanism behind the framing already on this page: total talus replacement is a move that forecloses options rather than preserving them, and at 30 the relevant question is not whether it works but what the second and third revisions cost.

Added August 4, 2026 — a fourth 2026 adverse-event report, and it is the fastest failure yet

One more total-talus report was found this week that previous sweeps missed. A 4WEB custom device was “explanted approximately three months following the initial surgery… tissue closure complications and a delayed wound. The 4WEB device was explanted… and replaced with an antibiotic spacer” [342]. It completes the 2026 picture for this device class: three of the four total-talus adverse-event reports filed in 2026 involve 4WEB implants — one lost at three months to wound failure, two at roughly six and six-and-a-half years to adjacent-joint erosion.

The comparison that matters is with his own history, and it is not close. This patient's 2012 bulk allograft ran from October 2012 to March 2025 — about twelve and a half years. The metal implants in these reports failed at three months and at roughly six years. Dr. Salk's estimate that a talar replacement would need replacing “every 10 years or so” is, against the reported failures, optimistic rather than conservative. None of this converts eighteen adverse-event reports into a failure rate — it cannot, and the limits stated above still apply — but it does mean the durability case for metal over biology is weaker here than it looks, because the biology already delivered twelve years in this exact ankle.

Added August 4, 2026 — the field still cannot say whether fusion or replacement is better

→ Useful mainly as a defence against anyone presenting either operation as the obvious eventual answer.

A review published August 3 compared total ankle replacement against ankle fusion across the 2023–2025 literature [349]. A level II multicentre study found long-term results “similar”; a meta-analysis favoured replacement on patient-reported outcomes; three systematic reviews found comparable outcomes and complication rates, though replacement showed “lower total complications, implant removals, adjacent level fusion surgeries, and non-union” afterwards. The authors conclude that “the existence of mixed evidence… makes it necessary to select the surgical technique… on an individual basis.”

Three honest discounts. It is a narrative review, so there are no pooled numbers. It covers end-stage arthritis, which is precisely where this ankle is not. And it does not stratify by age or by post-traumatic aetiology, so it never analyses the subgroup — under forty, post-traumatic, joint space preserved — that would actually describe him. What it is good for: if a surgeon frames fusion as the inevitable destination, the current literature does not support that being settled. The review also records that “racial/ethnic, socioeconomic, and payer status disparities have been reported in the likelihood of experiencing TAR versus AF” — a reason to ask why a particular option is being recommended.

Added August 13, 2026 — the adverse-event channel reopened after six weeks dark, and its two new reports extend the ladder to its last rung

→ The FDA database that produced every report above had been frozen since late June. It refreshed this week — and the July batch contains the two worst outcomes yet reported for this implant class: one conversion to fusion, and one patient who chose amputation.

The MAUDE dataset refreshed on August 5 (its receive-frontier jumped from June 30 to July 31, closing the 39-day blind spot the sweep logs had been measuring), and the July batch holds two further 4WEB custom total-talus reports, both received July 15 via the manufacturer’s routine annual survey [417]. The first: a total talus implanted in 2024 began to subside; a 2025 revision injected synthetic bone substitute to arrest it; a further 2025 revision explanted the construct entirely and converted to tibiotalocalcaneal fusion with another manufacturer’s spacer. The second, in a patient with pre-existing ankle and subtalar arthritis and talar AVN: the subtalar fusion accompanying the implant was “felt to be unstable and a persistent source of pain and disability” — and the patient elected below-knee amputation, the first amputation outcome anywhere in this device class’s reports.

The tally is now 20 reports all-time for the custom-talus product code, six received in 2026, five of them 4WEB. Every limit stated in the August 3 entry still applies — no denominators, counts are not rates, survey-solicited reports have their own bias — and one report of an elected amputation is an anecdote, not an outcome statistic. But the escalation ladder this page describes — each revision spending another hindfoot joint — previously ended, in the reported data, at “revising again.” It now has documented terminal rungs: conversion to fusion when the implant cannot be held, and amputation when the fusion itself becomes the pain source. That is what “forecloses options” means, written out by the reporting system rather than by this site.

Added August 18, 2026 — two databases, one morning, both scoring fusion-vs-replacement the same way

→ Two separate studies published the same day compared ankle fusion against ankle replacement using big insurance/hospital databases. Both favored replacement: fusion patients needed the next joint down fused about three times as often, and had far more short-term complications. Big caveats on both — but they point the same direction.

The fusion-vs-replacement ledger on this page has always carried “adjacent-joint arthritis” as fusion’s structural tax, mostly from older and smaller series. On August 17 the largest matched head-to-head yet on that line item arrived: a commercial-claims cohort of 2,105 ankle fusions vs 2,105 total ankle replacements, matched 1:1 on age, gender, indication and obesity [426]. At five years, 4.2% of fusion patients had gone on to subtalar fusion versus 1.4% of replacement patients — multivariate odds ratio 1.90, with age, gender, obesity and diagnosis all washing out. The mechanism is the one every fusion consult recites: a fused tibiotalar joint sends its motion demand to the neighbours, and the neighbours eventually bill for it.

The same morning, an HCA hospital-system cohort (732 replacements, 598 fusions, unmatched) reported the short-term side of the ledger [427]: replacement had lower surgical-site infection (3.1% vs 21.6%), zero amputations vs 1.7%, a quarter the 1-year readmissions (4.0% vs 16.1%), home discharge 99.2% vs 63.0%, and a two-day-shorter stay. Read the discounts before the numbers: [427] is unmatched — fusion patients in a hospital-enterprise database are systematically sicker and more post-traumatic, and a 21.6% infection rate for fusion is far above every published benchmark (registry series run 1–5%), which smells like broad coding capture rather than deep infections; its senior author consults for an implant company. [426] is claims data whose endpoint (subtalar fusion) undercounts subtalar arthritis, with follow-up capped near five years and a confidence interval grazing 1.0. What survives the discounting: two independent databases, on the same day, scored the trade the same direction on every endpoint. None of this bears on joint preservation — it bears on what each rung of the last-resort ladder costs, and it firms up this page’s standing observation that fusion’s price is paid by the joints around it.

MAUDE watch, same sweep: the dataset’s last_updated advanced August 5 → August 11, but the receive frontier is unchanged at July 31 — the refresh back-filled three additional routine TAA-component reports into July (Zimmer, Wright Infinity) and added no new reports in the custom total-talus class. The tally above stands.

Added August 22, 2026 — the only prospective multicenter fusion-vs-replacement cohort posts its eight-year numbers, and the gap narrows with time

→ The one study that followed real fusion and replacement patients forward, side by side, at five US hospitals for eight years just put its full results on the public trial registry. Replacement scored better on function at every visit, but the advantage shrank from about ten points at one year to about five at eight, and on general physical health the two were essentially tied by year eight. Fusion patients had about twice the complication rate in the first year.

Everything this page carries on fusion versus replacement is retrospective — registries, claims databases, single-centre series, and the meta-analyses built from them. The exception has existed since 2012 but never appeared here: NCT01620541, the VA Puget Sound / University of Washington prospective cohort led by Bruce Sangeorzan, which enrolled 517 patients with end-stage ankle arthritis at five sites (Seattle, Portland, Fort Collins, Grand Rapids, Edina) and followed them on the same instruments at the same intervals. On August 21 the study posted its results to ClinicalTrials.gov for the first time — pre-op, one, two, four and eight-year outcomes for 103 fusions and 414 replacements [432]. The two- and four-year cuts were published in JBJS in 2019 and 2021; the eight-year numbers are new, and this is the first time the whole trajectory sits in one table.

The shape is consistent on every measure. FAAM daily-living function: fusion 48→72 at one year, replacement 47→81 — a ten-point gap — then 74 vs 82 at two years, 72 vs 80 at four, and 67 vs 76 at eight, both arms drifting down from their peak. FAAM sports: 22→46 vs 20→59 at one year (a fourteen-point gap), narrowing to 46 vs 49 at eight years. SF-36 physical health: 36→44 vs 34→47 at one year, and 42.6 vs 43.2 at eight — indistinguishable. Average ankle pain went from 6 to 2.4 (fusion) and 6.3 to 2.1 (replacement) by eight years; worst pain from about 8.4 in both arms to 3.4 vs 3.1. In the first twelve months, 17 of 103 fusion patients (16.5%) versus 33 of 414 replacement patients (8.0%) had an ankle-specific complication; major surgical revisions ran 4 vs 7 (3.9% vs 1.7%) and minor revisions 9 vs 9 (8.7% vs 2.2%).

Read the discounts. This was a preference cohort, not a randomized one: patients and surgeons chose, and the fusion arm was nine years younger on average (54 vs 63) — in this literature the younger, more post-traumatic, more deformed ankles are the ones steered toward fusion, so the arms were never the same population. The registry posts means and standard errors per arm, not adjusted between-arm comparisons, so the gaps above are unadjusted. Adverse events were only collected to twelve months — the eight-year table says nothing about late implant revision, which is exactly where replacement’s costs accrue (see the registry and MAUDE entries above). And attrition was heavy: only 17 fusion and 93 replacement patients completed the eight-year visit, so the late means rest on a fraction of the enrolled cohort. The step-count outcome was posted with no data.

What survives. Three things, none of them about this ankle’s current decision. First, the prospective data agree with the retrospective ledger on direction — replacement buys better early function and fewer early complications — but the size of the functional advantage roughly halves between year one and year eight, and on generic physical health it disappears. Second, both operations left patients meaningfully better than baseline at eight years on every score, which is the more important fact for someone reading this page from a long way up the ladder. Third, this is a cohort that was still collecting data in April 2026, from the same Pacific-Northwest orthopaedic community that includes the Harborview and Scripps programs already on the action list; the posted point of contact is the study biostatistician at VA Puget Sound. A companion Medicare-claims analysis deposited the same day [433] is worth one line for its practical content: across 7,104 ankle fusions in patients 65 and older, the inpatient setting carried the highest infection rate (about 4–7 percentage points above outpatient and ambulatory-centre cases) and the highest 90-day cost (about $19,800) after adjustment and propensity matching — outpatient fusion, when a patient is healthy enough to be offered it, does not appear to be the riskier choice.

Added August 25, 2026 — and if replacement, there is now a validated model for who actually feels the difference

→ Out of 631 ankle replacements followed in one registry for up to twenty years, a model was built to predict which patients improve enough to notice. Only two things mattered: how disabled the ankle was to begin with, and whether the arthritis came from an unstable ankle. Worse starting disability and instability-caused arthritis both made a good result more likely — not less.

The Vancouver total-ankle registry group (Veljkovic, Penner, Younger, Wing — with Hospital Clínico Universidad de Chile) took 631 primary total ankle replacements from 2003–2023 and asked which patients achieved a clinically meaningful response, defined as a ≥28-point improvement on the Ankle Osteoarthritis Scale at one to two years [437]. After testing age, smoking, diabetes, BMI, inflammatory disease, etiology and eight prosthesis generations, the internally validated model (AUC 0.76, bootstrap-checked, calibration satisfactory) kept exactly two predictors: baseline AOS score (OR 1.06 per point) and instability-related etiology (OR 5.1). Implant choice did not survive model selection; neither did age or BMI.

Two readings matter for this page. First, the direction of the disability finding is the opposite of the intuition that surgery should be saved until things are unbearable because late surgery does worse — on this measure, the worse the starting point, the larger and more likely the meaningful gain, which is partly arithmetic (more room to improve) but is now quantified and validated rather than assumed. Second, instability-driven arthritis — the etiology this ankle would have if it ever reaches this page — is the best-responding etiology in the model, with five-fold odds of a meaningful result. Honest limits: internal validation only, no external cohort, a twenty-year registry spanning implant generations, an outcome ceiling at two years, and no fusion arm — it predicts who improves with a replacement, not whether replacement beats fusion for them ([432] remains the only prospective data on that question). Worth noting alongside: Stryker’s new-generation Incompass total ankle system began a 200-patient post-market outcome study this year (NCT07118501, five US sites recruiting, primary endpoint the same AOS scale at 24 months) — the implant ecosystem is now generating exactly the kind of prospective AOS data this model needs for external validation.

Added August 26, 2026 — and when a replacement gets infected: how often, who, and how it ends

→ Out of 1,008 ankle replacements at one large center, 27 got a deep infection around the implant — about 1 in 37. The strongest risk factor was having a heel-bone realignment cut done during the same surgery, which carried nearly ten-fold odds. The reassuring half: 96% of infected patients kept their leg, and about 70% kept a working replacement.

The infection thread on this page has so far run on databases — [435] found a coded mental-health disorder predicts infection across 29,705 replacements, [433] priced infection by surgical setting. A Rothman Institute (Thomas Jefferson) series published August 26 adds the institutional view with actual chart-level infection workups: 1,008 primary total ankle replacements, 2010–2023, with 27 prosthetic joint infections — a 2.7% rate [441]. After propensity matching and penalized regression, the risk factor that survived adjustment was a concomitant calcaneal displacement osteotomy — 9.75-fold odds of infection (CI 2.5–52.4), with cancer history also associated; BMI, diabetes and prior ankle surgery did not hold up as independent predictors. Staphylococcus aureus accounted for 36.7% of organisms, and about 30% of the infections were chronic by the time they were addressed.

Two readings for this page. First, the modifiable-risk story keeps getting more specific: the danger sign here is not the patient’s label but the amount of surgery done at one sitting — a same-day realignment osteotomy means more incisions, more time, more hardware, and this is the first series to put a number that size on it. An ankle that needs both realignment and replacement can stage them, and this is now an argument to ask about staging rather than bundling. Second, the outcome half is genuinely tempering: limb salvage 96.2%, arthroplasty retained in 69.2% at four years, with two-stage revision the workhorse strategy — deep infection after replacement is a bad year, not an amputation sentence. Honest limits: Level III, single institution, 27 events driving a wide confidence interval, and a 2.7% single-center rate that sits above the claims-database figures partly because dedicated centers find the infections they look for.

Added August 28, 2026 — and the one infection risk factor a patient can check with a blood draw

→ The same center behind the infection series above matched 1,542 ankle replacement patients and found that poor nutrition — measured by three ordinary blood tests before surgery — predicted nearly every bad outcome: readmission, wound problems, sepsis and clots in the first 90 days, and infection, fracture and even amputation out at five years. Unlike almost everything else on this page, this one is checkable and fixable in advance.

The infection thread on this page has been converging on the question of what is modifiable: [435] flagged a coded mental-health disorder at database scale, [441] put a 9.75-fold number on bundling a realignment osteotomy into the same sitting. A second Rothman Institute paper — same group as [441], published seventeen days apart and PubMed-indexed this week — adds the laboratory half [445]: across 1,542 propensity-matched total ankle replacements, patients with laboratory evidence of malnutrition in the three months before surgery (transferrin ≤ 204 mg/dL, leukocytes ≤ 1.5 × 10³/µL, or albumin ≤ 3.5 g/dL) had significantly more readmission, wound disruption, sepsis, myocardial infarction, pulmonary embolism, pneumonia and DVT within 90 days — and at five years more periprosthetic joint infection, revision to fusion, periprosthetic fracture and below-knee amputation.

Discounts first: Level III, retrospective, and lab-defined malnutrition travels with frailty, chronic disease and everything else matching cannot fully strip out — some of these associations are the company malnutrition keeps, not the albumin itself. What earns it a place anyway: every other predictor on this page is either fixed history or a surgical-planning choice. This is the first entry whose risk factor is a standard preoperative lab panel — something a patient can ask to have drawn, see for themselves, and spend the weeks before an elective surgery date correcting. The authors’ framing is exactly that: adequate transferrin, albumin and leukocyte values as a modifiable pre-surgical target. For an elective operation with no deadline, “fix the nutrition, then book the date” is now a citable sequence.

Added August 28, 2026 — and when a replacement fails on both sides of the joint, printed custom metal now has its first small numbers

→ Seven ankles whose replacements had failed got a fully custom rebuild: a 3D-printed stemmed plate for the shin-bone side sitting on a 3D-printed replacement of the entire talus bone. At almost two years, none had needed another operation and none of the implants had shifted — though patients still reported mild pain.

This page’s custom-metal coverage has so far run failure-first: the MAUDE reports track total-talus and custom implants from the adverse-event side, [430] covered printed cages for failed fusions (structure held, pain relief in only half), and [428] covered removing the talus entirely. A Rothman case series deposited August 27 — the group’s third TAA paper in four days — is the first in this site’s window to report the maximal custom reconstruction from the outcome side [446]: six patients (seven ankles) with failed primary replacements, revised with 3D-printed custom stemmed tibial trays seated on total talus replacements, six of seven with a subtalar fusion in the same construct. At a mean of 21 months: no reoperations, no lucency or subsidence, alignment unchanged from the first weight-bearing film to the last, and a mean pain score of 3.3 out of 10.

Discounts: seven ankles, Level IV, single surgeon, no comparison arm, no before-and-after function scores — and a residual VAS of 3 is a serviceable ankle, not a cured one. Its value here is the same as [428]’s: it fills in what the rung below a failed replacement actually looks like when it goes acceptably. The MAUDE thread above documents how these custom total-talus constructs fail; this is the first paired series showing the same class of construct holding — both bone surfaces patient-specific, printed, and stable at two years. Nothing about it bears on any decision this ankle currently faces, and the follow-up is far too short for an implant meant to outlast a patient’s remaining decades.

Added August 29, 2026 — and the same custom construct class now has a registered prospective study, in Europe

→ The Rizzoli Institute in Bologna — one of Europe’s oldest orthopaedic hospitals — is running a 26-patient study of a custom implant that combines a standard ankle-replacement top half with a 3D-printed replacement of the entire talus, for ankles that have lost too much bone for a normal replacement. It has been quietly enrolling since 2022 and was only registered this May; a news-shaped registry search only surfaced it now.

The entry above ([446]) gave the custom tibial-tray-on-total-talus construct its first retrospective numbers; until now, every entry in this class was either a case series or a MAUDE failure report. It turns out the class also has a registered prospective study [447]: NCT07569848, an observational pilot at the Istituto Ortopedico Rizzoli (Bologna), enrolling since February 2022 but registered only in May 2026, 26 patients planned, completion estimated 2028–2031 — a patient-specific device combining the tibial and meniscal components of a FAR-type ankle prosthesis (Adler Ortho) with a 3D-printed total talus replacement, implanted with custom cutting guides, for severe bone loss or bone compromise. The registration itself frames the design as descending from the 2021 FDA humanitarian-use talar spacer, extended into a full joint.

Discounts: observational, single-site, pilot-sized, Italy, and nothing published yet — this is a watch item, not evidence. Why it earns a line anyway: [446] showed the construct class holding retrospectively in seven ankles; this is the first prospective, registered study of the same class anywhere, and its existence means the class will eventually produce comparable, protocol-driven numbers rather than only single-surgeon retrospectives and adverse-event reports. Joined the registry watches alongside Rizzoli’s microfracture-plus-BMAC trial (NCT07555899); the watch is for its first results posting or paper.

Added September 1, 2026 — the replacement rung gets its contemporary benchmark: 98.2% of 502 implants surviving at five years, regardless of how bad the ankle looked going in

→ A UK study followed 502 ankle replacements with one modern implant for at least five years: 98% were still in place, and — surprisingly — how deformed or arthritic the ankle was beforehand made no difference to survival, complications, or how patients felt afterward.

This page’s replacement rung has been assembled from registries, databases and single-institution series; what it lacked was a large contemporary prospective benchmark for one modern implant. An eleven-centre UK cohort published August 31 supplies it [450]: 502 ankles (496 patients), primary Infinity fixed-bearing replacement, minimum five-year follow-up — survivorship 98.2%, reoperation without revision 5.8%, and function, pain and quality-of-life scores (MOxFQ, AOS, EQ-5D-5L) improved across the board. The headline finding is what didn’t matter: COFAS grade — the standard staging of deformity and surrounding-joint arthritis — predicted nothing: not revision, not reoperation, not lucent lines, not patient-reported outcome. The cohort matches the registered UK INFINITY post-market study (NCT03063593) this page’s registry watch has tracked — in size, sites and design — so the watch item that was quietly touched on August 28 appears to have produced its paper.

Discounts: an industry-adjacent post-market cohort with no comparison implant, and five years is the easy half of an ankle replacement’s life — the second decade is the one that matters at this patient’s age. Why it is carried: read beside [437], the two studies split the question cleanly — the Vancouver model says baseline disability and instability etiology predict who feels meaningfully better; this says baseline severity does not predict whether the implant survives. A worse-looking ankle is not, by itself, a reason to expect a worse replacement.

Added September 1, 2026 — and the fourth Rothman paper in a week: obesity doubles mechanical failure, and a bigger stem doesn’t buy the risk back

→ The same Philadelphia group that published the infection, nutrition and custom-revision papers this week also looked at weight: in 699 replacements, patients with a BMI over 30 had more than double the rate of mechanical failure needing revision — and using a bigger, more deeply anchored implant did not protect them.

The Rothman Institute’s August run ([441] infection, [445] malnutrition, [446] custom revision) closes with the risk factor everyone assumes and nobody had isolated this cleanly for modern implants [451]: 699 primary replacements 2010–2023, 39 mechanical failures (5.6%) at a mean of 5.6 years — BMI ≥ 30 carried an adjusted hazard ratio of 2.27 for mechanical failure requiring metal-component revision. The engineering half is the sharper result: tibial stem or keel augmentation — the “bigger anchor” a surgeon might reach for in a heavier patient — did not change the failure rate (93.7% vs 96.1% five-year survivorship, not significant, no BMI-by-implant interaction). Obese patients started with worse pain and function but reached comparable postoperative scores — the implant helps them as much; it just fails sooner.

Discounts: Level III, single institution, 39 events, BMI measured once. Why it is carried: with [445], the week’s pair of modifiable risk factors is now complete — nutrition labs and body weight, both checkable and workable before any surgery date exists, and topic 14 already carries the same factor at the OLT rung. The negative engineering result matters on its own: risk that lives in biology and load cannot be designed away at implant selection.

Added September 1, 2026 — a first registered study of a non-opioid painkiller class, specifically after ankle replacement

→ A new small study will test suzetrigine — the first drug in a new class of non-opioid painkillers, FDA-approved in 2025 — for pain right after ankle replacement surgery, with Vertex (the manufacturer) collaborating. Not recruiting yet; a watch item.

Registered August 31 [452]: NCT07795827, an investigator-sponsored Phase 4 exploratory cohort (n=28, Vertex Pharmaceuticals collaborating) of suzetrigine (Journavx) added to standard multimodal analgesia after primary total ankle replacement — the first-in-class NaV1.8 sodium-channel inhibitor approved for acute pain in January 2025, tested here in the specific operation this page covers. Single-arm, open-label, not yet recruiting, start planned October 2026, no sites posted. Why the line exists: every operation on this page carries a post-surgical opioid tail as part of its true cost, and this is the first registered attempt this sweep has seen to shorten that tail in ankle replacement specifically. A watch item — recruiting flip, sites, results.

Added September 1, 2026 (midday) — the fusion rung’s other construct question — what fills the joint — turns out to have a running randomized trial

→ When surgeons fuse an ankle, they usually pack the joint with bone harvested from the patient’s own heel or shin — a second surgical site that hurts and can cause its own problems. A company-sponsored randomized trial at seven US centres is now testing whether a synthetic bone putty works as well as the patient’s own bone, with a CT scan at six months as the referee. Recruiting now, ages 18–75.

The fusion rung carries outcomes ([432]), settings and costs ([433]), head-to-heads ([426], [427]) and, since August, the fixation construct ([436]) — but the other thing the surgeon chooses on the day, the graft packed into the joint, had no entry at all. A routine registry update surfaced one [453]: NCT07225751, Kuros Biosurgery’s Phase IV post-marketing RCT of MagnetOs synthetic calcium-phosphate putty used standalone against local autograft from the calcaneus or tibia, 126 patients randomized 1:1 across ankle and hindfoot fusions, primary endpoint CT-confirmed fusion at 24 weeks — recruiting at seven US sites including UC Davis (the nearest, in Sacramento) and Rothman. First posted November 2025; it had simply never crossed this sweep’s registry window until today’s update.

Discounts: an industry sponsor measuring its own product, participant-only blinding, and the trial answers only which void filler to use once fusion is already chosen — nothing about whether to fuse. Why it earns a line anyway: [436] turned nonunion risk into a fixation question a patient can raise in a consult; this is the graft half of the same conversation, and autograft harvest — a second incision in the heel or shin with its own pain and complication tail — is a cost this page had never priced. If fusion ever reaches the table, “what are you packing the joint with, and would this trial take me” are now both askable. Joined the registry watches (the eleventh).

Added September 3, 2026 — the watched revision paper posts its abstract: eleven failed replacements rebuilt through the fibula, all still salvageable at two years

→ A Baltimore group took eleven ankle replacements that had failed — seven loosened, four infected — and instead of fusing them, installed a different replacement that goes in through the outside ankle bone. Two years on: everyone kept a working replacement, pain improved significantly, but a third needed some further operation along the way.

The abstract watch opened August 26 closed this week: the Schon-group paper on revising failed total ankle replacements to a transfibular trabecular-metal prosthesis posted its abstract to PubMed [455]. Eleven ankles (average age 72), seven failed by aseptic loosening or subsidence and four by periprosthetic infection, revised at an average of nine years after the original implant — the four infections via two-stage revision, all successfully. At minimum two years: significant pain improvement (VAS and AOS), normal coronal and sagittal alignment, one re-revision (9%) and four reoperations (36%). The authors’ framing is the reason it belongs on this page: for select patients with a failed replacement “who wish to avoid fusion or amputation.”

Discounts: Level IV, eleven ankles, single institution, no comparison arm, and the senior author consults for and receives royalties from Zimmer Biomet — the manufacturer of the implant being studied. What it adds to the ladder: the revision-of-a-failed-replacement rung on this page previously ran through custom printed constructs ([446]), cages ([430]), talectomy-fusion ([428]) or the MAUDE failure reports; this is the first series here showing an off-the-shelf lateral-approach revision implant holding at two years with a 100% limb-salvage, 100% arthroplasty-retention record — small, short, conflicted, but a rung that had no numbers now has some.

Added September 3, 2026 — the first monthly deep registry pass finds restor3d building a 2,000-patient self-enrollment registry — the evidence vehicle its stalled post-approval study never became

→ The company that makes the main US 3D-printed talus implant has registered a 2,000-patient outcomes registry that patients join themselves, online, after receiving any of its custom implants — including foot and ankle. Its FDA-required follow-up study has been stuck at 2 patients; this is the company’s much bigger second attempt at evidence. Not yet open.

This sweep’s first monthly full-depth registry pass — searching standing trials by topic rather than by update date — surfaced NCT07563803, the restor3d Outcomes Registry [456]: a prospective, decentralized, 2,000-patient master-protocol registry capturing patient-reported outcomes from adults with any FDA-cleared or -approved restor3d patient-specific implant, across knee, hip, shoulder and foot-&-ankle cohorts, with patients self-enrolling and reporting electronically. Registered May 2026, not yet recruiting. The context this page already carries is what makes it notable: restor3d holds the only OLT-inclusive US total-talus label ([160]), it is the only such device still being commercialized after 4WEB’s exit ([213]), and its FDA post-approval study has been listed as Delayed, 2 patients enrolled since April ([212]). A decentralized self-enrollment registry is a far cheaper way to accumulate outcome data than a site-based study — and, for better or worse, it may become the main published evidence base for the implant class this page spends the most words on.

Discounts: sponsor-run, observational, patient-reported outcomes only, no comparator, and self-enrolled cohorts skew toward engaged, better-off patients. Why it earns a line and a watch anyway: the standing complaint in this page’s TTR sections is that the modern implants have almost no denominator — adverse-event counts with nothing to divide them by. Two thousand self-reporting patients would be the first denominator-shaped thing this device class has produced. Joined the registry watches (the twelfth): recruiting flip, and any foot-&-ankle cohort readout.

Added September 7, 2026 — the transfibular implant’s first mid-term series from outside its designer’s orbit, and the survival number holds up

→ The last two weeks brought two papers on the through-the-fibula ankle replacement from the Baltimore group that helped design it. Now a Tokyo hospital with no hand in the design reports its own 51 ankles at four-plus years: patients improved past the “you’d actually notice it” threshold on every score, and 95.5% of the implants were still in place at four years. The price: one in six had slow wound healing and one in ten cracked the inner ankle bone during or after surgery — though all of those healed without another operation.

The transfibular thread on this site has so far run through one group: the Schon revision series [455] and the deformity-correction cohort [462], both from the implant’s designer-consultant orbit. A Tokyo Women’s Medical University cohort published September 7 in Bone & Joint Open is the first independent mid-term read here [463]: 51 transfibular replacements at mean 4.3-year follow-up (minimum three), all SAFE-Q patient-reported domains improving beyond the minimal clinically important difference, motion gains arriving by three months and holding, and implant survival of 98.0% at three years and 95.5% at four — numbers that sit directly beside the incumbent-approach benchmark of 98.2% at five years in 502 implants [450]. The study’s stated question — whether an implant sized for Western anatomy fits smaller bones — answered itself: 70.6% of ankles took the two smallest-but-one sizes and none needed the largest two.

Discounts: retrospective, single centre, no comparator, 51 ankles; two authors report Zimmer Biomet speaker and consulting fees (declared unrelated, but it is the same manufacturer); and the complication profile is not trivial — delayed wound healing in 15.7% and medial malleolar fracture in 9.8%, even though every one healed without further surgery. What it adds to the ladder: the lateral-approach replacement now has a mid-term survival figure that does not come from its designers, and it lands within a point or two of the front-door benchmark — while its wound and malleolus numbers are the honest cost side of the through-the-fibula route.

Added September 19, 2026 — the through-the-fibula implant posts its first decade: 98.6% still in place at a mean eleven years, and the price is printed beside it

→ The through-the-fibula ankle replacement this page has been tracking now has its first ten-year report card. Of 71 replacements done between 2012 and 2016 by the Baltimore surgeon who helped design it, all but one were still in place at an average of eleven years — the single failure was a deep infection that ended in a below-knee amputation. The catch is on the same page: four in ten ankles needed some smaller operation along the way, most often clearing bone and scar from the gutters beside the joint. Scores, alignment and motion held steady between year five and year ten — the implant does not appear to be quietly deteriorating in the second half of the decade.

Every survivorship number in the transfibular thread above stops short of ten years: the designer-orbit cohorts [455]/[462] report at two and five, the independent Tokyo series [463] at four, and the incumbent-approach benchmark [450] at five. A Foot & Ankle International paper posted September 18 supplies the decade [485]: 71 primary transfibular trabecular-metal replacements (89.9% of the eligible 2012–2016 cohort) at minimum 10-year follow-up, mean 11.0 years — implant survivorship 98.6%, with exactly one metal-component revision: a periprosthetic joint infection that ended in below-knee amputation. Reoperation reached 40.8% (most commonly gutter debridement), cysts appeared in 7% of ankles, and patient-reported outcomes, alignment and motion were statistically stable between the 5-year and ≥10-year marks with minimal interval osteolysis. A same-issue commentary asks the question the thread has been circling — “After nearly 15 years, is it time we pay attention to the outcomes of the Zimmer TM total ankle?” — and this cohort is the first decade-scale answer.

Discounts: Level IV, one surgeon, and squarely inside the designer-consultant orbit this thread keeps flagging — the Zimmer Biomet consultant-and-royalty relationship noted at [455] belongs to this group; no comparator; and the survivorship definition does the framing work: 98.6% counts only metal-component revision, while the 40.8% reoperation rate — the same one-in-three-to-two-in-five band as the deformity cohort [462] — is the number a patient actually experiences. The infection-to-amputation case is one more entry in the pattern this page already carries: when a replacement fails hard, it fails expensively ([458], [469], [475]). What it changes on the ladder: the lateral-approach replacement is no longer a mid-term implant with a long-term question mark — it now has a decade figure, from its designers, that matches the front-door benchmarks; an independent decade series remains the missing piece.

Added September 10, 2026 — the “replace everything and keep it moving” construct gets a dedicated series: metal ankle on a metal talus, and the ladder’s heaviest motion-preserving rung now has real numbers

→ When an ankle replacement fails because the talus underneath it collapses — or the talus dies outright — the textbook answer has been to fuse ankle and hindfoot into one stiff column, an operation that itself fails to knit in up to a third of cases. A US group instead replaced both: a custom 3D-printed metal talus with an ankle replacement on top, in 18 patients. Recovery was fast (regular shoes by about 10 weeks) and no implant was removed — but a third of patients had a complication, and one ended in a below-knee amputation. Motion can be saved even at this extreme; the price when it goes wrong is the highest on this page.

The TTR section above lists combined total-ankle-plus-total-talus as technically possible [164] with no dedicated evidence behind it. A Foot & Ankle International series published this week supplies exactly that [469]: 18 patients (nine talar-component collapse after a prior ankle replacement, nine talar AVN with ankle and subtalar arthritis) treated with combined TAA plus custom 3D-printed total talus and a screw-and-BMAC subtalar fusion, at mean 36.8 months. Complications in 33.3% — 44% in the AVN group, 22% in the failed-replacement group — including two deep infections and one below-knee amputation for persistent pain and infection; reoperation 11.1%; and, when it went well, boot at under three weeks, full weight-bearing at under seven, regular shoes at 10.7 weeks, with talar-calcaneal osseointegration in every patient. The authors’ framing weapon is the alternative’s own number: tibiotalocalcaneal fusion, the traditional salvage, carries nonunion rates approaching 30%.

Discounts, which are heavy: retrospective, 18 patients, no comparator, recovery milestones rather than validated outcome scores in the abstract, custom-device evidence class — and a one-in-eighteen amputation is a worse tail outcome than anything in the TTR series above, which is saying something on a page that already carries the FDA’s one-joint-per-revision reports [322]. For this ankle the entry is strictly about optionality mapping: it is more evidence that even the far end of the far end — dead talus plus arthritic ankle — retains a motion-preserving exit that is not fusion. It is also more evidence that the exit is expensive, and that the “rigorous selection” its own authors insist on is doing a lot of work. A same-week footnote from the FDA channel: the MAUDE database’s reporting frontier finally advanced past July 31 during this sweep, and the August batch contains four new total-talus injury reports — two on 4WEB custom implants, two on Paragon 28 devices, narrative text not yet posted (one traces to an underlying event in May 2024). When the narratives post, they join the adverse-event thread above.

Added September 15, 2026 — the four August total-talus reports finally speak: an amputation, a six-and-a-half-year exchange, a nerve injury — and none of the three narratives blames the implant

→ Five days ago the FDA’s device-injury database listed four new reports on custom total-talus implants with the actual descriptions still blank. Three of the four have now posted. One is grim but not about the implant: a patient lost the lower leg after skin died around the surgical site — traced to the icing therapy used after surgery, with multiple rescue operations failing before the amputation. One is barely an adverse event at all: a custom talus placed in 2020 was exchanged for a new one this year, six and a half years later, with both operations described as uneventful. One is a nerve injury — numbness and an abnormal nerve-conduction test — that the manufacturer’s investigation deemed unrelated to the device. The fourth report is still blank, and the watch continues on that one.

The September 10 entry above logged four total-talus injury reports in MAUDE’s August batch with narrative text pending; the deferred read is now mostly in [475]. The 4WEB report received August 3: a below-knee amputation — the second amputation outcome in this device class’s reports, after the July case above — but attributed by the surgeon to postoperative skin necrosis associated with cryotherapy, in a patient with pre-existing arthritis and avascular necrosis, after multiple interventions and antibiotics failed. The second 4WEB report is not a failure story: an existing custom device implanted in 2020 was exchanged for a new custom device roughly six and a half years later, “no issues reported during either surgical procedure” — effectively a survivorship data point wearing an injury-report label. The Paragon 28 report received August 12: saphenous and superficial peroneal numbness with EMG-confirmed distal tibial neuropathy, investigated and deemed unrelated to the device. The fourth (Paragon 28, underlying event May 2024) remains narrative-less and stays on the re-pull list. Same pull, worth a line: the August whole-record baselines moved for the first time since anchoring (talus 7→23, talar 22→37) — a retroactive backfill that was scanned row by row: routine ankle-replacement component reports and collisions, no new reports in the total-talus class.

What the narratives change, stated carefully: the headline read on September 10 — four injury reports land on the class in one month — softens considerably on contact with the text. One report describes a complication of postoperative care (cryotherapy necrosis is a known, implant-agnostic surgical hazard); one describes routine-sounding revision at 6.5 years, squarely inside the adjacent-joint-erosion timeline the thread above already carries; one describes a nerve injury of the kind any hindfoot reconstruction can produce. None of the three adds a new implant-failure mechanism to the ledger, and the class’s standing tallies (the one-joint-per-revision sequence [322], the three-month wound explant [342], the subsidence-to-fusion and elective-amputation pair [417]) are unchanged. The standing caveats are also unchanged: no denominators, manufacturer-authored narratives, and a class whose entire evidence base still fits in a footnote — which is exactly why the restor3d registry [456] remains the watch that matters.

Added August 24, 2026 — if fusion, the screws themselves have a number now

→ A Japanese study of keyhole ankle fusions found that four screws beat three by a wide margin: with three screws, over 40% of fusions healed late or not at all; with four, under 8%. What predicted healing best wasn’t the screw count itself but how much of the talus the screws actually covered on the post-op CT scan.

The fusion rung of this page carries outcomes ([432]), settings and costs ([433]), and head-to-head comparisons ([426], [427]) — but nothing until now about the construct itself, the thing the surgeon actually chooses on the day. A 40-ankle arthroscopic-arthrodesis series published August 23 fills that line [436]: with a standardized home-run-plus-medial-parallel-screw technique, the three-screw group had a 42.9% delayed-union-or-nonunion rate against 7.7% with four screws, and the fusions that did unite healed in 7.3 weeks with four screws versus 12.4 with three. The sharper finding: on post-operative CT, the screw-to-talus area ratio — how much of the talar cross-section the screws pass through — predicted union better than screw count (AUC 0.85, with an exploratory threshold near 10%).

Discounts: Level III, 40 ankles, surgeon-chosen constructs rather than randomized, one institution, and a three-screw failure rate high enough above published benchmarks to suggest this cohort’s three-screw arm had other problems too. What it is worth here: fusion’s known failure mode on this page is nonunion, and this is the first entry that turns nonunion risk into a construct question a patient can raise in a consult — not “will it heal” but “how many points of fixation, and how much of the talus do they cover.”

Added August 20, 2026 — and when a fusion itself fails with bone loss, the cage rung now has early numbers too

→ Yesterday’s addition covered what happens after a failed implant. This one covers the other failure path — a fusion that fails leaving a hole in the bone — where surgeons are now printing custom titanium cages to fill the gap. In the first small series: the structure mostly holds, but only half the patients hurt less.

A five-patient “early experience” series published August 19 [430] describes custom 3D-printed titanium cages used to rebuild feet and ankles after failed arthrodesis with significant bone loss — failed tibiotalar and subtalar fusions among them. This is the failed-fusion counterpart to yesterday’s failed-implant salvage [428], and a niche this page’s 3D-printing coverage (custom revision implants, total talus, the talus spacer) has never included. The early returns are honest and mixed: at two years, 4 of 5 patients improved in physical function and 4 of 5 held their alignment — but only 2 of 5 met the clinically-important threshold for pain relief, one cage migrated with recurrent deformity, and one infection needed IV antibiotics (though no cage was removed). Level IV, five patients, mixed sites — the takeaway is narrow: the fusion-failure rung of the ladder also has a described reconstruction now, its structural results outrun its pain results, and nothing about it bears on any decision this ankle currently faces.

Added August 19, 2026 — the rung below the ladder finally has numbers, and they are better than its reputation

→ Everything above documents how replacements and fusions fail. A Madrid series published this week describes the operation that comes after those failures — removing the talus entirely and fusing shin bone to heel bone — and reports that five of six such patients ended with a stable, brace-free foot.

The adverse-event reports on this page keep ending at the same sentence: the construct failed and was “converted to tibiotalocalcaneal fusion.” Until this week that conversion had no outcome data anywhere on this site — it was a fate, not a procedure. A Hospital 12 de Octubre (Madrid) series published August 17 fills the gap [428]: 13 high-risk patients with destroyed tali — infection, avascular necrosis, post-traumatic collapse, Charcot, and aseptic loosening of a total ankle replacement — underwent total talectomy and tibiocalcaneal arthrodesis held by a computer-assisted hexapod ring fixator. Eleven of thirteen fused with the frame alone (mean 22 weeks); the two nonunions were converted to intramedullary nails and both went on to fuse. AOFAS improved from 39 to 74, pain from 5.1 to 1.4, and every fused patient ended with a stable, plantigrade foot that needed no brace — with no deep infections and no amputations in the series.

What this changes and what it does not. It is thirteen salvage patients, Level IV, two-year follow-up, and none of their indications resemble a post-allograft osteochondral lesion — nothing here is an argument for or against any operation this ankle is actually considering. Tibiocalcaneal fusion also pays the maximum structural price on this page: both the ankle and subtalar joints, plus limb length. Its value is narrower and real: the ladder’s terminal rung — the one the MAUDE reports reach when a total talus or TAA cannot be held — turns out to be a described, survivable operation with an 85% union rate and a functional foot at the end, rather than a synonym for amputation. When weighing options that can fail into this rung, it is worth knowing the rung holds.

Added August 12, 2026 — what recovery after TATTR looks like when it goes well, from the first published rehab protocol

→ Everything above is about whether and when the operation fails. This is the missing other half: one documented case of what a structured recovery from it looks like.

An Italian rehabilitation group published the first quantified rehabilitation case report after combined total ankle + total talus replacement [412]: a 59-year-old with talar AVN and advanced post-traumatic OA — the classic TATTR indication — went through five months of structured rehab (progressive strengthening, proprioceptive platform training, antigravity-treadmill gait retraining, visual-feedback gait optimization) and moved from Berg Balance 30 → 56, Tinetti 9 → 29, and EQ-5D index 0.169 → 1.0, with postural sway cut by three quarters. It is a single case — it says nothing about rates, durability, or the adverse-event ladder documented above, and a hand-picked publishable recovery is by definition a best case. Its use here is narrow: if this operation ever does become the plan, the recovery is not passive waiting — this names the rehab components a good program included, and shows independent function at five months is at least achievable.

Alternative: Partial Talus Replacement / Talar Hemiarthroplasty

→ Rather than removing the whole talus, this replaces only the damaged dome with a custom metal cap — potentially more anatomically proportional to a focal medial OLT or failed allograft than whole-bone replacement.

The evidence base here is small enough that it should not be presented as established. But it is absolutely worth asking about before accepting whole-talus replacement as the only metal option for a focal medial dome lesion.

Added September 6, 2026 — partial talus replacement gets its first three-digit comparison, and the operation it is compared against is fusion

→ A Chinese hospital looked back at 105 patients whose talus bone was dying and who got either a custom 3D-printed partial replacement of the bone or an ankle fusion. The replacement patients ended up with less pain, better function, better quality-of-life scores, and a moving ankle instead of a fused one — with no more complications and no reoperations. It’s a look-back study at one hospital, so it can’t prove the implant caused the difference — but until now this option had almost no comparative numbers at all.

The section above calls this evidence base “small enough that it should not be presented as established” — a 17-patient series [213], one case report [214], a 10-patient spacer cohort [215]. A Cangzhou (Hebei) group’s paper published this week in Medical Science Monitor changes the scale [461]: a retrospective cohort of 105 patients with extensive talar avascular necrosis treated 2021–2024 — 49 with digitally customized 3D-printed partial talus replacement, 53 with ankle arthrodesis. At last follow-up the replacement group led on every reported endpoint: AOFAS 85.9 vs 78.5, pain 1.7 vs 2.6 out of 10, ankle motion 48° vs about 1°, and SF-36 physical and mental scores roughly 13–18 points higher (all p < 0.001), with similar complication rates (8.1% vs 11.3%) and no reoperations in the replacement arm versus two in the fusion arm.

Read it with its limits: retrospective and non-randomized — surgeons chose who got which operation, and healthier ankles plausibly got the implant; single centre; the authors’ own title says “early clinical outcomes” and the abstract states no mean follow-up; the arithmetic is loose (105 enrolled, 102 in the arms); the motion advantage is structural, since fusion removes motion by design; and the indication is whole-bone AVN, not a focal medial dome lesion. What it changes here: the partial-talus rung was a plausibility argument resting on under 40 published patients; it now has a first real comparison against fusion, at 10× the scale, pointing the same direction as the small series — and the question to a surgeon shifts from “does anyone have numbers?” to “do these numbers survive a randomized design and Western replication?”

Who Is It For?

FDA-approved indications for the restor3d HDE (the broadest U.S. label) include [160]:

Important nuance: In the U.S., broad FDA HDE use of total talus replacement for large cystic talar osteochondral defects is currently device-specific rather than universal. The strongest official regulatory support comes from the restor3d implant, but most published TTR outcome studies still focus on AVN, talar collapse, or trauma rather than failed focal talar allograft. Candidacy also depends heavily on whether the tibiotalar, subtalar, and talonavicular joints remain healthy enough, because degenerative changes in those joints are listed as contraindications in official device labeling. Modern 3D-printed implants have encouraging early survivorship, but secondary surgeries, infection, and adjacent-joint degeneration remain important risks, and true long-term durability is still unknown.

For Raymond: TTR is not the first-line next step for the current situation. The standard algorithm for a focal OLT with preserved joint space places this lesion in the osteochondral allograft / autograft / MACI category. TTR is a real, on-label U.S. option for some large cystic talar OLTs via restor3d — but the published literature is still dominated by AVN, collapse, and trauma rather than failed focal talar allograft, and candidacy depends heavily on the condition of the tibial plafond, subtalar joint, talonavicular joint, and overall alignment. If cystic changes progress to AVN or talar collapse, TTR becomes more clearly indicated. At age 30, the key advantage over fusion is motion preservation; the key risk is that if it fails, salvage options become progressively more limited (primary salvage: TTC fusion). Partial talus replacement / talar hemiarthroplasty is a nearby option that may be more anatomically proportional to a focal medial dome lesion, though its evidence base is very small.

Questions to Ask Dr. Salk