Early Failures of Polyvinyl Alcohol Hydrogel Implant for the Treatment of Hallux Rigidus

Shimozono, Yoshiharu; Hurley, Eoghan T.; Kennedy, John G.

doi:10.1177/1071100720962482

Cited by 19 publications

(18 citation statements)

References 9 publications

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“…It is known that periprosthetic osteolysis can result from activated M1 macrophages expressing proinflammatory cytokines including interleukin-1, interleukin-6, and tumor necrosis factor-alpha. 15,16,30 The osteolytic features of implant failure in our study confirm the failure characteristics of the Synthetic Cartilage Implant as previously described, 31 with peri-implant lucency on radiographic examination suggesting osteolysis. Radiographs are known to underestimate periprosthetic osteolysis in the hip and ankle compared with CT, 20,28,35 and the present study demonstrates that clinical-grade CT can be used to quantify osteolysis.…”

Section: Discussionsupporting

confidence: 90%

“…11 In a recent study, 90% of implants showed subsidence, and a further 50% had implant loosening within 2 years of the index procedure. 31…”

mentioning

confidence: 99%

“…11 In a recent study, 90% of implants showed subsidence, and a further 50% had implant loosening within 2 years of the index procedure. 31 In combination, these outcomes suggest a need to further investigate the abnormalities associated with early implant failure. The purpose of this study was to characterize the pathological processes in bone, cartilage, and the synovial membrane after PVA hemiarthroplasty in an ovine model with 6 months of follow-up.…”

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confidence: 99%

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Early Failure of a Polyvinyl Alcohol Hydrogel Implant With Osteolysis and Foreign Body Reactions in an Ovine Model of Cartilage Repair

et al. 2021

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Background: Hemiarthroplasty using a polyvinyl alcohol (PVA) hydrogel synthetic implant has been suggested as a good alternative to arthrodesis for the treatment of hallux rigidus. However, failure rates as high as 20% have been recorded. Purpose: To characterize the pathological processes in bone, cartilage, and the synovial membrane after PVA hemiarthroplasty in an ovine model with 6 months of follow-up. Study Design: Controlled laboratory study. Methods: A unilateral osteochondral defect (8-mm diameter × 10-mm depth) was made in the medial femoral condyle in 6 sheep. Animals were randomized to receive a PVA implant (n = 4) or to have an empty defect (n = 2) and were monitored for 6 months. Patellofemoral radiographs were obtained at monthly intervals, and quantitative computed tomography was performed at the end of the study. After death, the joints were macroscopically evaluated and scored. Osteochondral and synovial membrane histological findings were assessed using modified Osteoarthritis Research Society International (OARSI) and aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) scoring systems. Immunohistochemistry using Iba1 was performed to evaluate activated macrophage infiltration. Results: Overall, 2 sheep with PVA implants were euthanized at 1 and 5 months because of uncontrollable pain and lameness (failed implants). Quantitative computed tomography showed that sheep with failed implants had 2.1-fold more osteolysis than those with successful implants. The sheep with failed implants had osteoarthritis with extensive glycosaminoglycan loss and cartilage fibrillation of the condyle and opposing tibial surface on histological examination. A foreign body reaction with severe chronic lymphoplasmacytic and granulomatous inflammation with giant cells was detected surrounding the implant. The synovial membrane ALVAL score was 9 of 19 and 14 of 19 in failed implants with synovial hyperplasia and lymphoplasmacytic and macrophage infiltration. In contrast, the synovial membrane in successful implants and empty defects was normal (ALVAL score = 0/19). Immunolabeling for Iba1 in failed implants confirmed extensive and dense macrophage infiltration within the condyle and synovial membrane, with the highest immunoreactive score (9/9). Conclusion: PVA hydrogel implants had a 50% failure rate with uncontrollable pain, severe osteolysis, inflammation, and foreign body reactions. Clinical Relevance: The failure rate and pathological characteristics of the PVA implants suggest that their use should not be continued in human patients without further in vivo safety studies.

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Section: Discussionsupporting

confidence: 90%

“…11 In a recent study, 90% of implants showed subsidence, and a further 50% had implant loosening within 2 years of the index procedure. 31…”

mentioning

confidence: 99%

mentioning

confidence: 99%

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Early Failure of a Polyvinyl Alcohol Hydrogel Implant With Osteolysis and Foreign Body Reactions in an Ovine Model of Cartilage Repair

et al. 2021

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“…This outcome was not easily reproducible. In a small retrospective study of 11 patients, Shimozono et al12 found a 43% failure rate at 20 months follow-up. Implant subsidence was predominantly the main culprit of failure.…”

Section: Resultsmentioning

confidence: 97%

Polyvinyl Alcohol Hydrogel Hemiarthroplasty of the First Metatarsophalangeal Joint Augmented With 3D-printed Baseplate

Madi

Chopra

Parekh

2022

Techniques in Foot &Amp; Ankle Surgery

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Hallux rigidus is the most common arthritic pathology of the foot and is a debilitating disease that causes pain, swelling, and reduced range of motion. Although arthrodesis is the gold standard treatment option, a soft hemiarthroplasty implant, the polyvinyl alcohol (PVA) hydrogel, has been designed to preserve motion in the first metatarsophalangeal joint and alleviate pain. Made from synthetic PVA and saline, the index noninferiority trial showed satisfactory clinical outcomes. However, this result was not reproducible by others with implant subsidence being a common concern. In this surgical technique, we describe a novel modified approach which involves PVA hemiarthroplasty of the first metatarsophalangeal joint, 3-dimensional-printed baseplate and Akin osteotomy to ultimately prevent likely implant failure.

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“…Although the MOTION trial demonstrated noninferiority for the prosthesis vs fusion, the results of subsequent independent reports following FDA approval have been mixed. 1,5,12 There have been subsequent positive reports as well, but these represented long-term follow-up of subsets of the original trial patients in whom the prosthesis had not been explanted. 6,7 These disparities may arise in part from reasonable but differing underlying philosophies of surgical outcomes.…”

Section: Introductionmentioning

confidence: 99%

Philosophies of Surgical Care Are Embedded in Outcome Studies: An Illustrative Reanalysis of the Cartiva MOTION Trial

Guyton

2022

Foot Ankle Int.

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Background: Subjective assumptions on the definition of surgical success are inherent to the design of clinical trials with a categorial outcome. The current study used reasonable alternative assumptions about surgical care to reassess data for the randomized controlled Cartiva trial (MOTION). Methods: Data from the published study were augmented by publicly accessible internal US Food and Drug Administration documents. As in the published report, 1-sided lower bound 95% CIs (LBCI95) for the difference of proportions were calculated for a series of alternative scenarios in which the assumptions underlying what constitutes surgical success were altered. Results: Using a noninferiority margin of −15%, the MOTION trial reported success based on a 1-sided LBCI95 of −10.9%. Each of the 3 independent alternative scenarios analyzed yielded results that altered the primary outcome of the trial: (1) eliminating failures based solely upon radiographs findings, thereby considering a painless pseudarthrosis as a success (1-sided LBCI95 of −15.9%), (2) considering only major surgical revision as a failure and discounting isolated hardware removal (1-sided LBCI95 of −15.1%), and (3) using a visual analog scale (VAS) pain threshold of <30 as the success criterion rather than a 30% reduction in VAS pain score (1-sided LBCI95 of −15.8%). Conclusion: In this reanalysis, applying any of 3 reasonable alternative assumptions about the definition of surgical success to the data resulted in failure to prove noninferiority of Cartiva over arthrodesis, a reversal of the reported trial result. These results highlight the effect of subjective assumptions in the design of clinical trials with a categorical outcome and illustrate how differing philosophies about what constitutes surgical success can be pivotal in determining the final result. Level of Evidence: Level II, prospective comparative study.

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Early Failures of Polyvinyl Alcohol Hydrogel Implant for the Treatment of Hallux Rigidus

Cited by 19 publications

References 9 publications

Early Failure of a Polyvinyl Alcohol Hydrogel Implant With Osteolysis and Foreign Body Reactions in an Ovine Model of Cartilage Repair

Early Failure of a Polyvinyl Alcohol Hydrogel Implant With Osteolysis and Foreign Body Reactions in an Ovine Model of Cartilage Repair

Polyvinyl Alcohol Hydrogel Hemiarthroplasty of the First Metatarsophalangeal Joint Augmented With 3D-printed Baseplate

Philosophies of Surgical Care Are Embedded in Outcome Studies: An Illustrative Reanalysis of the Cartiva MOTION Trial

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