Showing posts with label clinical outcomes. Show all posts
Showing posts with label clinical outcomes. Show all posts

Monday, June 8, 2026

Pyrocarbon Section 4: clinical data


In this post we take a bit of a deeper dive into the clinical information available regarding pyrocarbon humeral arthroplasty - looking at evidence from the Australian and New Zealand registries alongside the currently available reports on specific cohorts.

Please note that this is a "best effort" attempt to put together what's out there. If the reader finds any of this to be in error, please do let me know.


Newspaper-style, the post starts with a summary

and then presents data that may support the points presented in the summary.


1. There is no single “pyrocarbon shoulder” — there are at least three. Resurfacing (PyroTITAN, not FDA-cleared in the U.S.), the U.S. FDA-cleared stemmed pyrocarbon hemiarthroplasty, and the European stemmed hemiarthroplasty with systematic head-downsizing. Each uses different implants or different techniques; a finding for one may not transfer to another, and pooling them is a common error in this literature.

2. Registries present data on revision rate, not function. McBride 2026, the AOANJRR 2025 special clinical assessment, and the New Zealand registry agree that pyrocarbon is revised about as often as a good anatomic TSA. However revision is a surrogate endpoint: the observation that a patient's implant was not revised does not necessarily mean that the patient had good shoulder comfort and function (we know this from reverse total shoulders where patients living with poor postoperative comfort and function often do not have revision surgery).  What matters most to the patient and to us is the degree to which the arthroplasty improved the patient's quality of life.

3. The currently available data often do not relate to implants and techniques currently in use. Most series are based heavily on approaches no longer in play today.

4. Where patient-reported outcomes exist, they show - like just about every other type of shoulder arthroplasty - clinically significant improvement over the preoperative state that lasts 5–10 years. Appropriately controlled studies that compare clinical outcomes for pyrocarbon humeral arthroplasty to other surgical options for managing glenohumeral arthritis are, however, uncommon.

5. The one head-to-head functional comparison still favors total over hemiarthroplasty early on. In the New Zealand registry, anatomic TSA surpassed pyrocarbon hemi on the Oxford score at both 6 months and 5 years. Notably, the functional advantage of total over hemi is not eliminated by changing the use of pyrocarbon bearing surface.

6. Royalties or research funding from pyrocarbon implant manufacturers are disclosed in many of the cohort series.  That does not invalidate the data, but it is recognized that industrial support can affect study design, data analysis and conclusions.

7. The bearing surface is not the most important aspect of the reconstruction. As is the case for all other types of shoulder arthroplasty, the outcome of pyrocarbon arthroplasty is critically dependent on patient selection, component size, component positioning, glenoid management, soft tissue balancing, and rehabilitation.

Future clinical research will hopefully define the indications, the appropriate implants, the surgical technique, and the clinical outcomes for pyrocarbon humeral arthroplasty.


Now for the details

Two Australian Orthopaedic Association (AOANJRR) analyses: two different pyrocarbon devices. Both draw on the AOA registry, but they study different pyrocarbon configurations. Both presen revision/survivorship endpoints with no patient-reported outcomes.

1. McBride presents the pyrocarbon humeral hemi-resurfacing (PHR/PyroTITAN — a resurfacing cap, no head excision, the Australian research-restricted device that is not FDA-cleared for use in the U.S.), comparing PHR in patients <65 versus the five lowest-CPR (cumulative percent revision) aTSA combinations.

2. The AOA Annual Report also presents data on a hemi stemmed pyrocarbon implant. That stemmed configuration is basically the same as the U.S.-cleared device and the European (Boileau) stemmed construct.

To complement these registry studies, cohort reports concern the three pyrocarbon devices in current use: (1) resurfacing (PHR/PyroTITAN); (2) the U.S. stemmed hemiarthroplasty (FDA-cleared Tornier/Stryker); and (3) the Boileau/European stemmed hemiarthroplasty. Devices 2 and 3 share the same hardware (Aequalis Ascend Flex stem + pyrocarbon head) but have separate literature, study designs, and technique: the Boileau approach systematically downsized the component.

In the table above, each cell carries a generation/technique caveat: the long-term numbers may not describe the devices and techniques commonly used today.


AOANJRR 2025

The AOANJRR 2025 “hemi stemmed anatomic — pyrocarbon head” class does not differentiate U.S. vs Boileau technique.  This Annual Report compares four shoulder arthroplasty classes in patients under 60 with OA, restricted to prostheses still implanted in 2024 (the “modern prostheses” filter), with data to 31 December 2024. 


Note that the confidence intervals for all four classes overlap. Adjusted for age and sex, no comparison to the pyrocarbon hemi reached significance. The executive summary states it plainly: “a hemi stemmed anatomic with a pyrocarbon head was not different to traditional total shoulder replacement options in this age group.” The report contains no patient reported outcome data.

New Zealand National Joint Registry

Gao and colleagues reported the 159 stemmed pyrocarbon hemiarthroplasties (PyCHAs (Tornier Flex stem, pyrocarbon head) against 1,280 conventional metal HAs and 4,285 aTSAs. Importantly, average follow-up was shorter for PyCHA (3.3 yr vs 12.7 and 8.3). With this caveat, PyCHA retention (96.9%) was comparable to aTSA in patients under 60 and better than conventional metal HA on both retention and Oxford Shoulder Score. aTSA had numerically better Oxford scores than PyCHA at 6 months and 5 years.

Clinical outcomes and revision rates by device — the cohort series

The cohort series add what the registries omit — but they are single-arm, small, and almost all industry-linked. The registry analyses above report revision only; none measures a patient-reported outcome. The published cohort series below supply PROs, range of motion, and graded glenoid erosion — but each one is a single-arm case series (Level IV, no comparator), the largest is ~100 shoulders; follow-up is short-to-intermediate. They establish that each device improves shoulder scores against the patient’s own baseline; however, they do not establish superiority over aTSA or any other glenoid-sparing alternative. 


Resurfacing (PHR):  the contemporary third-generation resurfacing implant specifically has neither long-term revision nor any PRO follow-up. 

Hemiarthroplasty — US: the U.S. experience with the currently available implant is anchored by Griswold 2025 (JBJS), drawn from the Stryker pyrocarbon IDE cohort plus a subsequent prospective follow-up: 45 patients at a mean 73 months. Every PRO improved past MCID (ASES 47->96, Constant 48->88, SANE 39->94, VAS pain 5.0->0.2), satisfaction was 97.8%, and 7-year revision-free survival was 95.7% — both revisions for infection, none for glenoid erosion or breakage. 

Hemiarthroplasty — Boileau / European: the largest, longest evidence. The European stemmed device is the same Ascend Flex + pyrocarbon-head hardware as the U.S. implant, but placed with systematic head downsizing, anchored by the Boileau (Nice) and Garret/Godenèche (Lyon) groups, and corroborated by two independent European centers.

Cointat 2022 (64 shoulders, 92% survival at 3 yr), Garret 2024 (45 patients, 4.4% revision, scores maintained at 5–9 yr), and Boileau 2026 (103 shoulders, revision-free 94% at 5 yr and 89% at 10 yr) consistently show Constant rising from the mid-30s to ~80, SSV from ~35 to ~84, and return to work and sport above 90%. Mathon 2023 (Marseille; 41 shoulders, Constant 34->80 at 3 yr, 100% return to work, glenoid wear <0.6 mm on CT 3D modeling, no revisions) and Kleim 2024 (Munich/Agatharied; 31 shoulders, Constant 45->79 sustained to 5.5 yr, MCID surpassed in every diagnosis, medial glenoid erosion only ~0.3 mm/yr after a biphasic first year, 100% survival).  Kleim independently reproduced Boileau’s finding that glenoid reaming does not drive more erosion. 

The dominant, reproducible failure mechanism across the series was humeral-head oversizing: the pyrocarbon head sits ~2 mm proud of a metal head of equal diameter (a 1.5-mm support tray plus a 0.5-mm taper gap), nonanatomic reconstruction occurred in 24–29% of cases, and in Boileau’s series nonanatomic reconstruction carried a roughly 19-fold higher revision rate (25% vs 1.3%) along with worse erosion and function — which is why the group now downsizes the head by one size as routine. 

What the cohort series add — and still cannot settle. 

These series add to the registries: all three devices produce within-patient PRO gains exceeding MCID, durable to 5–10 years, with infrequent revision. However, there is still no well-controlled comparison against aTSA or any other glenoid-sparing alternative.


Summary

What the evidence supports:

• Resurfacing PHR (McBride): no detectable difference in revision risk versus best-in-class aTSA in patients <65 with OA — on a research-restricted device that is not available in the U.S., with shorter followup and thinner data, adjusted for age and sex only.

• AOA Annual Report: Stemmed pyrocarbon hemiarthroplasty not different from anatomic TSA with respect to revision rate at up to 7 years in patients <60 with OA. 

• New Zealand registry: In comparison to conventional metal hemiarthroplasty, both pyrocarbon configurations are at least non-inferior; pyrocarbon may outperform metal hemi with respect to implant retention.

• Cohort series: For each device-and-technique combination studied, patient-reported and clinician scores rise from baseline by margins exceeding MCID and hold to 5–10 years — across the resurfacing device (Caughey), the U.S. stemmed implant (Griswold), and the European stemmed implant at five centers (Cointat, Garret, Boileau, Mathon, Kleim). 

What the current evidence does not support:

• Any comparative effectiveness with respect to patient reported outcomes. The registries do not report PROs; the cohort series report PROs with clinically significant preoperative to postoperative gains, but lack well-controlled studies comparing clinical benefit relative of pyrocarbon to aTSA or other glenoid-sparing alternatives.

Conclusion

Future clinical research is needed define the indications, the appropriate implants, the surgical technique, and the clinical outcomes for pyrocarbon humeral arthroplasty relative to other methods for managing glenohumeral arthritis.

While the gold standard for comparing surgical treatments is a prospective randomized controlled trial, this is difficult to accomplish with meaningful numbers in a procedure performed on relatively few, highly selected patients. Authors therefore turn to propensity matching to compare separately collected series. The approach carries two challenges. The first is deciding which characteristics to match on — diagnosis? Walch type? how the glenoid was managed? length of follow-up? age? sex? The variables that most influence the result, such as Walch type and glenoid management, are often the very ones not recorded in the comparison series, so they cannot be matched even in principle. The second is attrition: cases are lost both because stricter matching discards more unmatched cases and because missing data remove others, so the compared groups end up a fraction of the original cohorts — sometimes a small one — and no longer fully representative of them. The commentary by Sanchez-Sotelo is required reading on this point (Pyrocarbon Shoulder Hemiarthroplasty Seems to Outperform Metallic Hemiarthroplasty at a Short-Term Follow-up. JBJS Am2026;108(8):529–530. DOI: 10.2106/JBJS.25.01142)




There is work to be done


Pileated woodpecker


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References

1. McBride A, Hurley R, Gill D, Du P, Duke P, Taylor F, Hoy G, Page R, Ross M. Outcomes of pyrolytic carbon humeral resurfacing hemiarthroplasty compared to best-in-class total shoulder arthroplasty in young patients with osteoarthritis: analysis from the Australian Orthopaedic Association National Joint Replacement Registry. J Shoulder Elbow Surg. 2026;35(5):1209–1218. doi:10.1016/j.jse.2025.09.007.

2. Australian Orthopaedic Association National Joint Replacement Registry. Hip, Knee and Shoulder Arthroplasty: 2025 Annual Report. Adelaide: AOA; 2025. Special Clinical Assessment: Shoulder Implant Choice — patients aged <60 years with OA (Table ST110, Figure ST77); data to 31 December 2024.

3. Gao R, Viswanath A, Frampton CM, Poon PC. Short-term outcomes following 159 stemmed pyrolytic carbon shoulder hemiarthroplasties and how they compare with conventional hemiarthroplasties and total shoulder arthroplasties in patients younger than 60 years with osteoarthritis: results from the New Zealand National Joint Registry. J Shoulder Elbow Surg. 2023;32(8):1594–1600. doi:10.1016/j.jse.2023.01.020.

4. Caughey MA, Penny I, Frampton CM. Medium-term results of the Ascension Pyrotitan surface replacement and Pyrocarbon hemiarthroplasty in the shoulder. Semin Arthroplasty JSES. 2024;34(1):1–10. doi:10.1053/j.sart.2023.01.005.

5. Griswold BG, Berger JM, Davis BP, Mauter L, Boyd M, Schuette HB, Johnston PS, Sears BW, Hatzidakis AM. Five-year radiographic and clinical outcomes of pyrocarbon hemiarthroplasty for glenohumeral arthritis and osteonecrosis. J Bone Joint Surg Am. 2025;107(24):2751–2762. doi:10.2106/JBJS.25.00163.

6. Cointat C, Raynier JL, Vasseur H, Lareyre F, Raffort J, Gauci MO, Boileau P. Short-term outcomes and survival of pyrocarbon hemiarthroplasty in the young arthritic shoulder. J Shoulder Elbow Surg. 2022;31(1):113–122. doi:10.1016/j.jse.2021.06.002.

7. Garret J, Cuinet T, Ducharne L, ReSurg, Godenèche A. Pyrocarbon humeral heads for hemishoulder arthroplasty grant satisfactory clinical scores with minimal glenoid erosion at 5-9 years of follow-up. J Shoulder Elbow Surg. 2024;33(2):328–334. doi:10.1016/j.jse.2023.06.021.

8. Boileau P, Cointat C, Raynier JL, Schippers P, Ranieri R. Pyrocarbon hemiarthroplasty for the treatment of shoulder osteoarthritis in young, active patients: survival and risk factors for revision. J Shoulder Elbow Surg. 2026;35(2):421–437. doi:10.1016/j.jse.2025.06.021.

9. Mathon P, Chivot M, Galland A, Airaudi S, Gravier R. Pyrolytic carbon head shoulder arthroplasty: CT scan glenoid bone modeling assessment and clinical results at 3-year follow-up. JSES Int. 2023;7:2476–2485. doi:10.1016/j.jseint.2023.06.028.

10. Kleim BD, Zolotar A, Hinz M, Nadjar R, Siebenlist S, Brunner UH. Pyrocarbon hemiprostheses show little glenoid erosion and good clinical function at 5.5 years of follow-up. J Shoulder Elbow Surg. 2024;33(1):55–64. doi:10.1016/j.jse.2023.05.027.

11. Lajoinie L, Garret J, van Rooij F, Saffarini M, Godenèche A. Pyrocarbon hemi-shoulder arthroplasty provides satisfactory outcomes following prior open Latarjet. J Shoulder Elb Arthroplast. 2024;8:24715492241292857. doi:10.1177/24715492241292857.

12. Barret H, Garret J, Favard L, Bonnevialle N, Collin P, Gauci MO, Boileau P. Long-term (minimum 10 years) survival and outcomes of pyrocarbon interposition shoulder arthroplasty. J Shoulder Elbow Surg. 2025;34:739–749. doi:10.1016/j.jse.2024.05.026.

13. U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo Classification Request for Tornier Pyrocarbon Humeral Head — Decision Summary. DEN220012. Silver Spring, MD: FDA; granted December 16, 2022. (Regulatory decision file for IDE G140202; documents the propensity-subclassified historical cobalt-chrome control [Tornier Flex CoCr, n=169] from the Aequalis Post-Market Outcomes Registry. The composite-clinical-success analysis was subsequently published as Hatzidakis 2026, ref 14.)

14. Hatzidakis AM, Garrigues GE, Mauter LA, de Gast A, Venegoni MR, Yang Y, Johnston PS. Clinical Outcomes of Pyrocarbon Hemiarthroplasty: A Short-Term, Multicenter Study. J Bone Joint Surg Am. 2026;108(8):572–583. doi:10.2106/JBJS.25.00054. 

15. Sanchez-Sotelo J. Pyrocarbon Shoulder Hemiarthroplasty Seems to Outperform Metallic Hemiarthroplasty at a Short-Term Follow-up. Commentary on Hatzidakis et al. J Bone Joint Surg Am. 2026;108(8):529–530. doi:10.2106/JBJS.25.01142. (Independent JBJS commentary flagging the 43% missing control data as substantially weakening the study, the 2-year follow-up as very limited, the absence of radiographic assessment of humeral-head reconstruction, and the need to compare pyrocarbon HA with contemporary anatomic TSA using modern polyethylene.)



Sunday, April 19, 2026

Component malposition and clinical outcomes in shoulder arthroplasty - are they related?

It seems intuitive that substantial malposition of shoulder arthroplasty components can lead to poor clinical outcomes.  


The assumption that malposition drives poor outcomes has become the rationale for investment in three-dimensional planning, patient-specific instrumentation, navigation, augmented reality, and robotics. However, examination of published evidence indicates that the relationship between measured component position and patient-reported outcomes is weaker than this narrative implies. For example Negligible Correlation between Radiographic Measurements and Clinical Outcomes in Patients Following Primary Reverse Total Shoulder Arthroplasty concluded that the relationship between measured component position and clinical outcomes is limited. Does postoperative glenoid component retroversion following anatomic total shoulder arthroplasty affect clinical outcomes? A systematic review and meta-analysis found no clinically significant difference in patient-reported outcome scores, range of motion, or complications for anatomic total shoulder arthroplasty glenoid components implanted with <15° versus ≥15° of postoperative retroversion across 15 studies and 1,190 shoulders. 

Humeral and glenoid component malposition in patients requiring revision shoulder arthroplasty: a retrospective, cross-sectional study measured component positions for TSA and RSA on pre-revision radiographs of patients having revision arthroplasty and compared these measures to "ideal" values for glenoid inclination, critical shoulder angle, glenosphere overhang, change in center of rotation, humeral head height, acromio-humeral interval, and humeral stem alignment. These measurements were not made on radiographs obtained immediately after the index arthroplasty, so the extent of postoperative component shift is not known.

The article found that the majority of glenoid components in these revision cases were malpositioned in relation to the "ideal" values for both TSA (51%) and RSA (93%) when all of the measures were considered. Similarly, there was humeral component malposition in 57% of TSA cases and 62% of RSA cases when all of the measures were considered.  

The prevalence of malpositioning in unrevised arthroplasties was not presented in this study.

Data such as that shown in graph A  (showing hypothetical values for unrevised shoulders) would suggest that malposition was not an important driver of revision.



On the other hand, data such as that shown in graph B would suggest that malposition was an important driver of revision.

This article did not provide data on the relationship of the degree of malposition to the rate of revision.

Data such as that shown in hypothetical graph C would suggest that the degree of malposition was tightly related to the revision rate.

Data such as that shown in hypothetical graph D would suggest that smaller degrees of malposition did not affect revision rate, whereas substantial degrees of malposition were clinically important.

What the literature does provide is evidence against a meaningful dose-response relationship. 

Below is a Forest plot of some key published studies relating glenoid component version to patient-reported clinical outcomes for aTSA and RSA. The effect sizes near zero with confidence intervals crossing the null line suggest the lack of a clinically meaningful dose-response relationship between glenoid component version and clinical outcome.



Below is a scatterplot showing the lack of a relationship between SANE and ASES scores and glenoid component version (data from Glenoid retroversion does not impact clinical outcomes or implant survivorship after total shoulder arthroplasty with minimal, noncorrective reaming).





Conclusion: A search of the currently available literature did not show a relationship between immediate postoperative radiographic measures of component position on one hand and clinically meaningful measures (such as patient-reported outcomes and revision rates) on the other. Such data will be important in demonstrating the potential clinical value of preoperative plan transfer technologies such as robotics, patient-specific instrumentation, navigation, and virtual/augmented reality. The thought that "continued improvements in component positioning technologies for both the glenoid and humeral implants are needed" will need to be supported by these analyses.

References
1. Checketts JX, Sanchez B, Norris G, Williamson TK, Hachadorian ME, Hsu JE, Schiffman CJ, Matsen FA III. Does postoperative glenoid component retroversion following anatomic total shoulder arthroplasty affect clinical outcomes? A systematic review and meta-analysis. J Shoulder Elbow Surg. 2026;35(5):1103–1116.
2. Sperling JW, Anderson MB, Jobin CM, Verborgt O, Duquin TR. Humeral and glenoid component malposition in patients requiring revision shoulder arthroplasty: a retrospective, cross-sectional study. J Shoulder Elbow Surg. 2025;34(8):1886–1896.
3. Service BC, Hsu JE, Somerson JS, Russ SM, Matsen FA III. Does postoperative glenoid retroversion affect the 2-year clinical and radiographic outcomes for total shoulder arthroplasty? Clin Orthop Relat Res. 2017;475(11):2726–2739.
4. Sheth MM, Mills ZD, Dasari SP, Whitson AJ, Matsen FA III, Hsu JE. Anatomic total shoulder arthroplasty for posteriorly eccentric and concentric osteoarthritis: a comparison at a minimum 5-year follow-up. J Shoulder Elbow Surg. 2025;34(2):473–483.
5. Matsen FA III, Whitson AJ, Somerson JS, Hsu JE. Anatomic total shoulder arthroplasty with all-polyethylene glenoid component for primary osteoarthritis with glenoid deficiencies. JB JS Open Access. 2020;5(4):e20.00002.
6. Grantham WJ, Dekker TJ, Lacheta L, Horan MP, Goldenberg BT, Elrick BP, et al. Total shoulder arthroplasty outcomes after noncorrective, concentric reaming of B2 glenoids. JSES Int. 2020;4(3):644–648.
7. Ma CB, Xiao W, Salesky M, Cheung E, Zhang AL, Feeley BT, et al. Do glenoid retroversion and humeral subluxation affect outcomes following total shoulder arthroplasty? JSES Int. 2020;4(3):649–656.
8. Rutledge JC, Dey Hazra RO, Geissbuhler AR, Yamaura K, Dey Hazra ME, Hanson JA, et al. Does glenoid version and its correction affect outcomes in anatomic shoulder arthroplasty? A systematic review. J Shoulder Elbow Surg. 2024;33(7):e384–e399.
9. Chalmers PN, Granger EK, Orvets ND, Patterson BM, Chamberlain AM, Keener JD, et al. Does prosthetic humeral articular surface positioning associate with outcome after total shoulder arthroplasty? J Shoulder Elbow Surg. 2018;27(5):863–870.
10. Werner BC, Creighton RA, Denard PJ, Lederman E, Romeo A, Griffin JW. Prosthetic humeral head center of rotation shift from ideal is associated with inferior clinical outcomes after anatomic total shoulder arthroplasty. Semin Arthroplasty JSES. 2021;31(4):668–676.
11. Varady NH, Bram JT, Chow J, Taylor SA, Dines JS, Fu MC, et al. Inconsistencies in measuring glenoid version in shoulder arthroplasty: a systematic review. J Shoulder Elbow Surg. 2025;34(2):639–649.
12. Terrier A, Ramondetti S, Merlini F, Pioletti DD, Farron A. Biomechanical consequences of humeral component malpositioning after anatomical total shoulder arthroplasty. J Shoulder Elbow Surg. 2010;19(8):1184–1190.
13. Franta AK, Lenters TR, Mounce D, Neradilek B, Matsen FA III. The complex characteristics of 282 unsatisfactory shoulder arthroplasties. J Shoulder Elbow Surg. 2007;16(5):555–562.
14. Sanchez-Sotelo J, Sperling JW, Rowland CM, Cofield RH. Instability after shoulder arthroplasty: results of surgical treatment. J Bone Joint Surg Am. 2003;85(4):622–631.
15. Burns DM, Frank T, Whyne CM, Henry PDG. Glenoid component positioning and guidance techniques in anatomic and reverse total shoulder arthroplasty: a systematic review and meta-analysis. Shoulder Elbow. 2019;11(2 Suppl):16–28.
16. Navarro RA, Chan PH, Prentice HA, Pearl M, Matsen FA III, McElvany MD. Use of preoperative CT scans and patient-specific instrumentation may not improve short-term adverse events after shoulder arthroplasty: results from a large integrated health-care system. JB JS Open Access. 2023;8(3):e22.00139.
17. Hsu JE, Hackett DJ Jr, Vo KV, Matsen FA III. What can be learned from an analysis of 215 glenoid component failures? J Shoulder Elbow Surg. 2018;27(3):478–486.
18. Walch G, Young AA, Boileau P, Loew M, Gazielly D, Molé D. Patterns of loosening of polyethylene keeled glenoid components after shoulder arthroplasty for primary osteoarthritis: results of a multicenter study with more than five years of follow-up. J Bone Joint Surg Am. 2012;94(2):145–150.
19. Harold RE, Sweeney PT, Torchia MT, Chamberlain AM, Keener JD. Total shoulder arthroplasty in patients with a B2 glenoid addressed with corrective reaming: mean 8-year follow-up. J Shoulder Elbow Surg. 2023;32(6 Suppl):S8–S16.