Early Outcomes and Complications of Synthetic Cartilage Implant for Treatment of Hallux Rigidus in the United States

Abstract

Background: The aim of this study was to determine the early outcomes and complications following the implantation of a hydrogel synthetic cartilage implant (SCI, Cartiva) for the treatment of hallux rigidus by a single surgeon. Methods: A retrospective chart review was performed of consecutive patients who underwent treatment for hallux rigidus with an SCI between August 2016 and April 2018 by a single surgeon. Demographic information, radiographic assessment, and concomitant operative procedures performed were evaluated for all patients. Postoperatively, PROMIS physical function (PF) and pain interference (PI) scores, patient satisfaction, reoperation, conversion to arthrodesis, and need for further clinical treatment were collected. Sixty-four SCIs were implanted in 60 patients. Follow-up averaged 18.5 months (range 12-30 months). Results: 14% (9/64) of patients were very satisfied, 28% (18/64) satisfied, 20% (13/64) neutral, 11% (7/64) unsatisfied, and 27% (17/64) very unsatisfied with their outcome. In addition, 45% of patients underwent additional procedures at the time of SCI, and 23% had a history of surgery on the hallux before implantation. PROMIS PF scores averaged 42 and PROMIS PI scores averaged 60. Overall, 63% completed PROMIS PI, 66% completed PROMIS PF, and 100% completed a satisfaction survey. In addition, 30% (19/64) underwent magnetic resonance imaging (MRI) postoperatively due to pain. There was a 20% reoperation rate, which included an 8% rate of conversion to arthrodesis. Conclusion: Synthetic cartilage implantation yielded neutral patient satisfaction, mild pain, and physical dysfunction at early follow-up. We believe patient selection and counseling regarding early postoperative limitations are important before proceeding with SCI. Level of Evidence: Level IV, case series.

Patient-Reported Outcomes and Early Complications After Synthetic Cartilage Device Implantation

“…The survey data in this study only slightly differs from the study by Cassinelli et al 4 In their retrospective cohort, they found that 66% of patients surveyed would have the procedure performed again. They also had a 20% reoperation rate, although this study had a rate of 16.9%.…”

“…The preoperative hallux rigidus grading was different compared to the Baumhauer et al study, 2 which showed 29% grade 2, 55% grade 3, and 16% grade 4. The Cassinelli et al 4 study was also different, which showed 25% grade 2, 60% grade 3, and 13% grade 4. The grade of hallux rigidus may not matter, however, as has been previously demonstrated.…”

“…With a recent retrospective case series 4 demonstrating conflicting results with the initial level I SCI study, 2 this article adds more cases to the current literature and provides a multisurgeon experience without a major confounding factor of postoperative intra-articular corticosteroid injections. Overall, the current study demonstrates that patients undergoing SCI implantation had improved VAS pain scores, good patient outcomes, and that the majority of patients would have the procedure performed again.…”

“…It is unclear how this may have impacted the clinical outcome but it may simply be an indication that a significant number of patients were not satisfied. 4 The goal of this study was to report patient-reported outcomes and early complications using a synthetic cartilage implant in the treatment of hallux rigidus. This was a multisurgeon study performed in the United States without confounding postoperative intra-articular injections.…”

“…It is unclear how this may have impacted the clinical outcome but it may simply be an indication that a significant number of patients were not satisfied. 4…”