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

Abstract

Background: Previous Level I studies show promising results for the use of a hydrogel synthetic cartilage implant (SCI) for the treatment of hallux rigidus. A recent independent retrospective review has put those results into question, however. The purpose of this article is to report patient-reported outcomes and early complications using this implant so as to add to the paucity of data in the literature regarding this implant. Methods: This was a retrospective chart review of patients undergoing hydrogel synthetic cartilage implant for the treatment of hallux rigidus from July 2017 to November 2018. Data collected included patient demographics, radiographic grading, and outcomes: Veterans Rand 12 Item Health Survey (VR-12), Foot and Ankle Ability Measure (FAAM), visual analog scale (VAS), patient satisfaction, and complications. Fifty-four patients (59 feet) with an average age of 57.6 (range, 39-78) years were analyzed. The average latest follow-up was 18.9 (range, 3-31.3) months. Body mass index was 26.7 (range, 18.7-35.2). None were diabetic and 5 were smokers. Results: The mean outcome improvements were 6.5 points (VR-12 Physical), 17.2 points (FAAM ADL), 27.4 points (FAAM Sport), and 18.4 points (VAS) ( P < .01 for each). Scores were significantly improved from preoperatively to most recent follow-up for FAAM ADL (71.0 vs 88.2 points), FAAM Sports (44.6 vs 72.0 points), and VAS (49.4 vs 31.0) ( P < .01). Overall, 72.5% patients would definitely or probably have the operation again. Ten patients (18.5%) went on to have revision surgery. Of these, 7 patients were revised to an arthrodesis, and 1 metal hemiarthroplasty and 2 implants were removed because of infection. Conclusion: Synthetic cartilage implantation for the treatment of hallux rigidus demonstrated improved pain and outcome scores at short-term follow-up. Reoperation and conversion to fusion rates were comparable to prior studies. Level of Evidence: Level IV, case series.

Surgical Outcomes of Synthetic Cartilage Implant Hemiarthroplasty for Metatarsophalangeal Arthropathy

“…This study found that 55% of patients were still experiencing pain at the final follow-up. The success of SCI surgery in reducing pain from baseline is well founded with reports of significant improvement in PROMIS pain interference/intensity [ 20 ], VAS [ 11 , 21 , 25 ], and MOXFQ [ 24 ] scores from as early as six weeks post-surgery. However, despite these significant improvements, a plethora of studies still report patients experience persistent pain [ 26 ].…”

“…We found a total revision rate to arthrodesis of 8.7% due to reduced joint space with implant degeneration and a stress fracture causing subsidence and valgus drift. The short-term revision rate varied considerably in the literature from 1.9% [ 20 ] to 16.9% [ 21 ] within two years, increasing to 27.8% when considering only symptomatic patients (Table 4 ) [ 15 ]. In the largest multicenter randomized controlled trial, Baumhauer et al reported a revision rate of 9.2% within two years due to persistent pain of unknown cause [ 11 ].…”