Polyvinyl alcohol hydrogel implant for the treatment of hallux rigidus is associated with a high complication rate and moderate failure rate at short-term follow-up: a systematic review.

PURPOSE: Moderate-to-severe hallux rigidus is a debilitating pathology that is optimally treated with surgical intervention. Arthrodesis produces reliable clinical outcomes but is limited by restriction in 1st metatarsophalangeal joint range of motion. The advent of polyvinyl alcohol hydrogel (PVA) implants have produced early promise based on initial trials, but more recent studies have called into question the efficacy of this procedure. The purpose of this systematic review was to evaluate the clinical and radiological outcomes following the use of PVA for hallux rigidus. METHODS: The MEDLINE, EMBASE and Cochrane library databases were systematically reviewed using the preferred reporting items for systematic reviews and meta-analyses guidelines. 18 studies were included. RESULTS: In total, 1349 patients (1367 feet) underwent PVA at a weighted mean follow-up of 24.1 ± 11.1 months. There were 168 patients (169 feet) included in the cheilectomy cohort and 322 patients (322 feet) included in the arthrodesis cohort. All 3 cohorts produced comparable improvements in subjective clinical outcomes. Postoperative imaging findings in the PVA cohort included joint space narrowing, peri-implant fluid, peri-implant edema and erosion of the proximal phalanx. The complication rate in the PVA cohort, cheilectomy cohort and arthrodesis cohort was 27.9%, 11.8% and 24.1%, respectively. The failure rates in the PVA cohort, cheilectomy cohort and arthrodesis cohort was 14.8%, 0.3% and 9.0%, respectively. CONCLUSION: This systematic review demonstrated that PVA produced a high complication rate (27.9%) together with concerning postoperative imaging findings at short-term follow-up. In addition, a moderate failure rate (14.8%) and secondary surgical procedure rate (9.5%) was noted for the PVA cohort. The findings of this review calls into question the efficacy and safety of PVA for the treatment of hallux rigidus. LEVEL OF EVIDENCE: IV.

Use of synthetic cartilage implant (Cartiva®) for degeneration of the first and second metatarsophalangeal joint: what is the current evidence?

Polyvinyl alcohol hydrogel implants (also known as Synthetic Cartilage Implant or Cartiva® have been described in the treatment of degeneration of the first and second metatarsophalangeal joint (MTPJ). We reviewed literature to report characteristics of devices on the market and investigate their efficacy and safety. Following the PRISMA checklist, the Medline and Scopus databases were searched, including studies reporting use of Cartiva® for treating joint degeneration of the first and second MPTJ. Studies were searched for surgical technique, postoperative protocol, clinical scores, complications and reoperations. We found that, although some studies suggest that the use of Synthetic Cartilage Implant (Cartiva® is effective in the treatment of hallux rigidus in providing symptoms relief without sacrifice of joint motion, the redundancy of cohorts reported in studies and the frequency of conflict of interest reported by authors weaken the strength of evidence available and warrant further studies. Regarding the treatment of the second MTPJ ailments, no recommendation can be formulated to date due to the lack of primary studies.

Treatment of first metatarsophalangeal joint arthritis using hemiarthroplasty with a synthetic cartilage implant or arthrodesis: A comparison of operative and recovery time.

BACKGROUND: First metatarsophalangeal joint (MTPJ1) hemiarthroplasty using a novel synthetic cartilage implant was as effective and safe as MTPJ1 arthrodesis in a randomized clinical trial. We retrospectively evaluated operative time and recovery period for implant hemiarthroplasty (n=152) and MTPJ1 arthrodesis (n=50). METHODS: Perioperative data were assessed for operative and anaesthesia times. Recovery and return to function were prospectively assessed with the Foot and Ankle Ability Measure (FAAM) Sports and Activities of Daily Living (ADL) subscales and SF-36 Physical Functioning (PF) subscore. RESULTS: Mean operative time for hemiarthroplasty was 35±12.3min and 58±21.5min for arthrodesis (p<0.001). Anaesthesia duration was 28min shorter with hemiarthroplasty (p<0.001). At weeks 2 and 6 postoperative, hemiarthroplasty patients demonstrated clinically and statistically significantly higher FAAM Sport, FAAM ADL, and SF-36 PF subscores versus arthrodesis patients. CONCLUSION: MTPJ1 hemiarthroplasty with a synthetic cartilage implant took less operative time and resulted in faster recovery than arthrodesis. LEVEL OF EVIDENCE: III, Retrospective case control study.

The Philosophy of Surgical Success and Outcomes of Cartiva Versus Fusion.

Noninferiority studies in surgery are, by their very nature, reductionist. They use multiple variables to generate a yes or no answer about the new device being tested. A binary outcome is appropriate for a regulatory agency such as the Food and Drug Administration, but the clinical situation is more nuanced. It is critical to understand the underlying philosophies and choices that go into trial design when a surgeon is recommending a new device. In the case of Cartiva, any of 3 reasonable alternative means of defining surgical success would have altered the final outcome of the MOTION trial. Additionally, using a more rigorous noninferiority margin rather than adding an additional cushion based upon the argument that motion alone had extra inherent value would have also led to failure of the trial to demonstrate noninferiority.

Patient Satisfaction Following Hallux Rigidus Treatment With a Synthetic Cartilage Implant.

BACKGROUND: There remains no clear consensus on patient satisfaction and functional outcomes following synthetic cartilage implant (SCI) implantation for hallux rigidus. The purpose of this study was to review our experience at a single academic institution using an SCI for treatment of hallux rigidus. METHODS: A retrospective review was performed of patients who underwent the SCI procedure for treatment of hallux rigidus between January 2017 and May 2019. Functional outcomes were evaluated using Patient-Reported Outcome Measures Informational System (PROMIS)-10 scores as well as a survey investigating patient satisfaction, self-reported clinical improvement, and changes in sporting ability. Patients were divided into satisfied versus unsatisfied subgroups, and between-group differences in preoperative variables and complications were reviewed. A total of 90 patients (96 implants) were included in this study. The mean follow-up time was 26.4 months. RESULTS: In all, 81.2% of patients reported that their foot was "much improved" (55.2%) or "improved" (26.0%) since undergoing the SCI procedure, whereas a slightly lower percentage, 74.0%, stated that they were "extremely satisfied" (41.7%) or "satisfied" (32.3%) at final follow-up. Patients were able to tolerate higher impact sporting activities after the procedure, and 75.0% of patients stated they would have the same surgery again. PROMIS-10 T-scores averaged 54.2 points for physical health and 57.4 points for mental health. Only 2.1% of patients required conversion to arthrodesis. Significant differences between the satisfied versus unsatisfied subgroups were found in preoperative corticosteroid injection use (21.1% vs 41.1%, respectively; P = .029) and preoperative VAS pain score (8.2 vs 7.1, respectively; P = .036). CONCLUSION: The SCI procedure can be a viable option for treating hallux rigidus with high satisfaction overall, increased sport activity levels, and a very low revision rate. However, maximizing patient satisfaction may require more careful consideration of preoperative prognosticators and extensive patient counseling to ensure realistic expectations for recovery time and individual outcome. LEVEL OF EVIDENCE: Level IV: Retrospective case series.

Revision Surgery After Failed Index Synthetic Cartilage Implant Resurfacing for Hallux Rigidus: Single-Surgeon 5-Year Experience.

BACKGROUND: While metatarsophalangeal joint (MTPJ) arthrodesis is regarded as the gold standard treatment option for end-stage hallux rigidus (HR), synthetic cartilage implant (SCI) resurfacing has gained popularity. This study aimed to identify the SCI resurfacing failure rate for a single surgeon, while also comparing clinical outcomes of patients who underwent SCI replacement or MTPJ arthrodesis after failed index SCI resurfacing. METHODS: Health records were queried from 2016 to 2021 for patients with HR who were treated with SCI resurfacing by a single surgeon. Preoperative and postoperative range of motion, visual analog scale (VAS) pain scores, and hallux valgus angles were compared. A subgroup analysis was performed on patients who underwent revision with SCI replacement or MTPJ arthrodesis. SCI replacement included the use of bone graft, bone putty, or a custom 3D printed baseplate to prevent implant subsidence. RESULTS: A total of 219 SCI resurfacing procedures were performed by a single surgeon, including 23 revisions. When analyzing index procedures, an 8.2% revision rate was determined. The revision cohort (n = 23) consisted of 19 female patients and presented with a mean body mass index of 29.5 ± 5 kg/m2, mean age of 52.8 ± 11 years, mean follow-up duration of 22.3 (range, 3-54) months, and mean time to a revision surgery of 12.1 ± 12 (range, 1-50) months. Specifically, 12 procedures resulted in an SCI replacement, while 11 procedures resulted in arthrodesis. While all patients experienced significant improvement in their VAS pain scores (P < .001), the arthrodesis cohort experienced a greater improvement than the SCI revision cohort (P = .04). CONCLUSION: When analyzing SCI revision procedures, MTPJ arthrodesis reduced pain more significantly than SCI replacement. LEVELS OF EVIDENCE: Level IV: Retrospective case series.

Surgical Outcomes of Synthetic Cartilage Implant Hemiarthroplasty for Metatarsophalangeal Arthropathy.

Introduction Metatarsophalangeal joint (MTPJ) arthropathy in the great toe causes considerable pain and debilitation, severely impacting quality of life. Traditional management options included conservative measures, steroid injections, and arthrodesis. New options include Cartiva, a synthetic cartilage hemiarthroplasty for the MTPJ. This prosthesis has evidence of improved pain and function without the sacrifice of joint movement seen with arthrodesis. However, the implant itself has mixed reviews. This study aims to identify the pre-, peri, and short-term post-surgical outcomes of Cartiva surgery and review the literature for existing reported outcomes. Methods We retrospectively reviewed a cohort of 22 consecutive Cartiva procedures between 2016 and 2022 in a single UK institution. Hospital records were analyzed for peri-operative complications, implant survival, additional operative interventions, patient-reported outcomes, and functional improvement. Results Twenty-one patients underwent Cartiva for the first MTPJ pathology and one for the third MTPJ pathology. Prior to surgery, 40.9% of patients had undergone alternative therapies, including MTPJ steroid injections (seven patients), cheilectomy (four patients), and bunionectomy (one patient). Total complication rates, inclusive of medical, surgical, and implant complications were 45.5% (10/22). Total reoperation rates were 18.2% (4/22) including two revisions to arthrodesis and two manipulations under anesthesia (MUA) with local anesthetic injection. At the final follow-up, 55% were still experiencing pain, 15% neurovascular symptoms, 10% swelling, and 50% stiffness or reduced range of movement. However, 85% of patients returned to usual activities of daily living within two years. Conclusion Cartiva surgery for metatarsophalangeal arthropathy has demonstrated outcomes of persistent pain, limited range of movement, and restricted function at short-term follow-up. Rates of reoperation and revision to arthrodesis were comparable with similar studies.

Adverse Events Related to Cartiva Hemiarthroplasty of First Metatarsal: An Analysis of Reports to the United States Food and Drug Administration.

Background: The results supporting Cartiva, a synthetic cartilage implant (Wright Medical) in hallux rigidus have come from limited institutions creating observational bias. Complications experienced in community centers are not routinely included in the published literature. To look at a broader range of potential complications, we reviewed the United States Food and Drug Administration's (FDA) voluntary device database and compared that data with published literature. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database of the FDA was retrospectively reviewed between July 2016 and October 2019 using the product code: PNW, assigned for Cartiva. Results: A total of 49 events have been reported and implant subsidence was the most common with 16 reports. Others include fragmentation (9), infection (4), bone erosion (3), foreign body reaction (1) and unspecified (16). Thirty-five events mentioned further surgeries at a mean interval of 4.75 months. Conclusions: The analysis of the MAUDE database disclosed certain device-related dysfunctions that have been underreported in the published literature. Because of the voluntary nature of reporting, the true incidence of each complication is unknown with this data representing a baseline. The MAUDE database could be further strengthened by a more robust reporting mechanism or mandatory reporting of device-related complications.Levels of Evidence: Level IV: Case series from large database analysis.

Complications of Hallux Rigidus Surgery.

Hallux rigidus can be treated with a variety of surgical procedures, including joint preserving techniques, arthrodesis, and arthroplasty. The most commonly reported complications for joint preserving techniques consist of progression of arthritis, continued pain, and transfer metatarsalgia. Although good outcomes have been reported for arthrodesis overall, careful attention must be paid to technique and positioning of the toe to avoid nonunion or malunion. Arthroplasty preserves motion but in the case of failure can present the additional challenge of bone loss. In these scenarios, the authors recommend distraction bone block arthrodesis with structural autograft.

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

BACKGROUND: The purpose of this study was to evaluate the clinical and radiological outcomes following a polyvinyl alcohol hydrogel implant in the treatment of hallux rigidus. METHODS: A retrospective cohort study investigating patients treated with a polyvinyl alcohol hydrogel implant for hallux rigidus was performed. Clinical outcomes were evaluated with the Foot and Ankle Outcomes Score (FAOS) and visual analog scale (VAS) score at the final follow-up. Plain radiographs were assessed postoperatively. Eleven patients (11 feet) with a mean follow-up of 20.9 months (range, 14-27 months) were included. The mean age was 60.3 years. RESULTS: All FAOS subscales showed pre- to postoperative improvements, but there was no statistical significance in all subscales. The mean VAS score showed improvement from 4.1 to 3.0 (P = .012). On postoperative plain radiographs, implant subsidence was observed 60% (6/10) at 4 weeks after surgery and 90% (9/10) at the final follow-up. Fifty percent (5/10) showed radiologic lucency around the implant. Forty percent (4/10) had erosion of the proximal phalanx of the great toe. Four patients (36%) reported no improvement following surgery at the final follow-up, which were considered as failures. Three patients required additional surgery related to the implants. An additional patient is waiting to revise the implant. CONCLUSION: Our current cohort study demonstrated a high failure rate with the polyvinyl alcohol hydrogel implant in patients with hallux rigidus. Significant radiologic subsidence with lysis around the implant, erosion of the proximal phalanx countersurface, and implant wear are harbingers for concern in the long term. LEVEL OF EVIDENCE: Level IV, case series.

Cartiva case series: The efficacy of the cartiva synthetic cartilage implant interpositional arthroplasty at one year.

BACKGROUND: The Cartiva synthetic cartilage implant (SCI) is licenced for use in management of symptomatic hallux rigidus in several countries including the UK. As of now, there are no independent series for treatment of hallux rigidus utilising polyvinyl alcohol implants. METHODS: Patients at a single centre with symptomatic hallux rigidus who underwent Cartiva implant interpositional arthroplasty were identified. First metatarsophalangeal joint arthritis was radiographically graded according to the Hattrup and Johnson (HJ) classification. Pre-operative and post-operative patient-reported outcomes (PROMs) were evaluated using the Foot and Ankle Ability Measure (FAAM) activities of daily living subscale and the Manchester-Oxford Foot Questionnaire (MOXFQ). RESULTS: 55 patients (14M, 41F) (37R and 18L) were followed up for an average of 21 months (min = 12, max = 38). 14 patients suffered from HJ2/moderate arthritis and 41 patients with grade HJ3/severe arthritis.Post-operative mean FAAM scores showed statistically significant improvement (p < 0.0001). Patients reported a 40% increase in functionality during activities of daily living.All 3 MOXFQ Domain scores improved significantly (p < 0.02). The Index score improved by 34 points (p < 0.0001).There was no correlation between length of follow up or age and PROMs (r = 0.129). No statistical difference was demonstrated between sexes. Clinically, however, males and older patients exhibited better outcomes. CONCLUSIONS: Our study shows excellent results with statistically significant improvements in functional outcomes, and promising short-term follow-up with low early revision rates. Durability and survivability of the implant will continue to be studied in this cohort.

Radiographic and Magnetic Resonance Imaging of the Symptomatic Synthetic Cartilage Implant.

BACKGROUND: Synthetic Cartilage Implantation (SCI; Cartiva) is a treatment of hallux rigidus associated with mixed clinical outcomes in the United States. Patients with persistent pain typically undergo diagnostic imaging for evaluation. We aimed to characterize the radiologic findings of SCI and surrounding tissues. METHODS: This is a retrospective review of patients treated using SCI who underwent magnetic resonance imaging (MRI) for persistent pain. Metatarsophalangeal (MTP) joint spaces were compared on plain radiographs of the foot immediately postoperatively and at most recent follow-up. MRI of the foot were assessed for dimensions of the implant, bony channel, and presence of peri-implant fluid. Clinical follow-up, including Patient-Reported Outcome Measures Informational System (PROMIS) scores, satisfaction rating, and revision surgery, was collected. Eighteen cases of symptomatic SCI from 16 patients (13 females, 3 males) were included. All but 1 case involved a 10-mm implant. RESULTS: Mean satisfaction rating was 2.25 (1-5 Likert scale). PROMIS scores indicated moderate physical dysfunction (41) and moderate pain interference (63). Six of 16 patients (37.5%) underwent revision surgery at average 20.9 months of follow-up. Plain radiographs over a 13.3-month interval showed joint space narrowing of 2 mm medially and 1.6 mm laterally (P < .001). One hundred percent of cases had radiographic evidence of osteoarthritis (OA) progression. MRI studies were obtained on average 11.5 months postoperatively. The implant diameter averaged 9.7 mm, which mismatched the bony channel diameter of 11.2 mm (P < .001). Fourteen of 18 cases had peri-implant fluid. All cases had edema in the metatarsal, proximal phalanx, and soft tissues. CONCLUSION: Radiographic loss of MTP joint space and progression of arthritis were present for all cases studied. MRI revealed bony channel widening and a smaller implant, with peri-implant fluid suggesting instability at the implant-bone interface. Persistent edema was observed in soft tissues and bone. Diagnostic imaging of SCI in symptomatic patients demonstrated concerning findings that merit further correlation with patient outcomes. LEVEL OF EVIDENCE: Level IV, case series.

Cost Comparison of Synthetic Hydrogel Implant and First Metatarsophalangeal Joint Arthrodesis.

Background. First metatarsophalangeal (MTP) arthrodesis is the "gold standard" treatment for hallux rigidus. Recently, there has been increased interest in new synthetic cartilage implants to preserve joint motion while eradicating pain. With current health care economics, the cost of a treatment is gaining particular importance. This study set out to perform a cost comparison between MTP arthrodesis and synthetic hydrogel implant to determine which treatment modality is more cost-effective based on direct aggregate costs. Study design. Economic and decision analysis. Methods. Studies in the available literature were analyzed to estimate hardware removal rates for MTP fusion and failure rates for a synthetic hydrogel implant and MTP fusion. Costs were determined by examining direct costs at a single institution for implants and data reported in the literature for operating room time. Sensitivity analysis and Monte Carlo simulation were performed to examine cost and measurement uncertainty. Results. Assuming a 4.76% MTP arthrodesis revision rate and 7.06% hardware removal rate, the total direct cost of MTP joint arthrodesis was $3632. Using a 9.2% failure rate with subsequent conversion to MTP arthrodesis, the total cost of synthetic hydrogel implant was $4565. Sensitivity analysis revealed that MTP fusion was more cost-effective even if the failure rate increased to 15% and synthetic hydrogel implant failure rate was 0%. The synthetic cartilage implant cost would have to be reduced 28% or approximately 200% the cost of MTP fusion implants to be comparable to MTP arthrodesis. Conclusion. Hallux rigidus treatment with a synthetic hydrogel implant resulted in a higher direct aggregate cost than MTP arthrodesis.Level of Evidence: Level II: Cost analysis.

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

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.

Comparing the efficacy of Cartiva synthetic cartilage implant hemiarthroplasty vs osteotomy for the treatment of conditions affecting the second metatarsal head.

BACKGROUND: Cartiva synthetic cartilage implants (SCI) have been designed for treatment of conditions affecting the second metatarsal head. Osteotomies are regularly performed for the treatment of conditions affecting the second metatarsal head such as Freiburg's disease. A comparative study between these two procedures has not yet been performed. METHODS: Patients at a single centre with symptomatic conditions affecting the second metatarsal head who received Cartiva SCI or a primary Osteotomy were identified, and patient-reported outcomes were evaluated using MOXFQ and the FAAM questionnaires. RESULTS: Six Cartiva SCI and 7 Osteotomy patients were identified and included in this study. All patients were female and were followed up for an average of 19 months (SD +/- 5.6) and 27 months (SD +/- 10.9) respectively. Cartiva SCI MOXFQ Index scores improved by 13 points from 57 to 44 (33%). Walking/and Pain domain scores improved, however, Social interaction deteriorated. Mean FAAM scores improved by 10% from 65% to 75%, and subjective FAAM scores improved by 7% from 48% to 55%. Four of the six Cartiva patients (3 Freiberg's disease and 1 Osteochondral defect) had revisions to Weil osteotomies at a mean of 15 months post-operatively. The Osteotomy group had improved MOXFQ Index and 3 Domain scores. FAAM scores improved by 26% from 66% to 92% and subjective FAAM scores improved by 28% from 60% to 88%. CONCLUSIONS: Second metatarsal head osteotomies result in high functional outcomes and should be the mainstay of treatment, especially when there is avascular necrosis of the metatarsal head.

Preliminary Experience With Polyvinyl Alcohol Hydrogel Implant for Pathology of the Second Metatarsal Head.

BACKGROUND: There is no consensus regarding which surgical technique is most beneficial for pathology of the second metatarsophalangeal joint. We report the use of polyvinyl alcohol hydrogel synthetic cartilage implant hemiarthroplasty for pathology of the second metatarsal head that has failed nonoperative treatment and present 5 cases with a minimum 15 months of follow-up. METHODS: The technique for synthetic cartilage hemiarthroplasty of the second metatarsal head is described. The postoperative protocol included weightbearing as tolerated for 2 weeks and moderate limitations in activities of daily living to respect wound healing, followed by physiotherapy for range of motion exercises. Charts for patients who underwent this procedure between 2015 and 2017 were retrospectively reviewed. Outcome measures collected postoperatively included a pain visual analog scale, Short-Form 36 (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, and Foot and Ankle Ability Measure (FAAM) Sports and Activities of Daily Living (ADL) current level of function percentages. RESULTS: At 15 to 38 months of follow-up, patients reported little to no pain and good range of motion, with no complications. Mean outcome measure scores were 89 for FAAM ADL, 75 for FAAM Sports, 44.4 for SF-36 PCS, and 52.1 for SF-36 MCS. CONCLUSION: This preliminary study of synthetic cartilage hemiarthroplasty for treatment of joint-destructive conditions of the second metatarsal head demonstrated good outcomes and no complications in 5 cases at a mean 25 months of follow-up. Large prospective cohort studies are needed to prove the efficacy and safety of this new surgical technique for the treatment of pathology of the second metatarsal head. LEVEL OF EVIDENCE: Level IV, retrospective case series.

New Technology in the Treatment of Hallux Rigidus with a Synthetic Cartilage Implant Hemiarthroplasty.

Synthetic cartilage implant surgery is an excellent option for the patient with great toe arthritis and good alignment of the toe who wishes to retain first metatarsophalangeal motion and obtain 90% improved pain relief and function. Patients with osteoporosis, osteopenia, or bone defects from surgery or disease may not maintain the implant position due to poor bone quality, resulting in less than desired outcomes. Despite this being a straightforward surgery, patients need to be aware that the pain relief may not begin until 3+ months after surgery because this procedure does require bone resection and implant placement.

Midterm Outcomes of a Synthetic Cartilage Implant for the First Metatarsophalangeal Joint in Advanced Hallux Rigidus.

BACKGROUND:: A prospective, randomized, noninferiority clinical trial of synthetic cartilage implant hemiarthroplasty for hallux rigidus demonstrated functional outcomes and safety equivalent to first metatarsophalangeal (MTP) joint arthrodesis at 24 months. We prospectively assessed safety and efficacy outcomes for synthetic cartilage implant hemiarthroplasty at a minimum of 5 years. METHODS:: Of 135 eligible patients from the original trial, 112 (83.0%) were enrolled (mean age, 58.2 ± 8.8 years; 87 females). Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL), and FAAM Sports subscales were completed preoperatively and 2 and 5 years postoperatively. Great toe active dorsiflexion, weightbearing radiographs, secondary procedures, and safety parameters were also evaluated. RESULTS:: At 24 months, 14/152 (9.2%) patients had undergone implant removal and conversion to arthrodesis. In years 2 to 5, 9/119 (7.6%) patients underwent implant removal and conversion to arthrodesis. At mean 5.8 ± 0.7 (range, 4.4-8.0) years' follow-up, pain VAS, FAAM ADL, and FAAM Sports scores improved by 57.9 ± 18.6 points, 33.0 ± 17.6 points, and 47.9 ± 27.1 points, respectively, from baseline. Clinically significant changes in VAS pain, FAAM ADL, and FAAM Sports were reported by 103/106 (97.2%), 95/105 (90.5%), and 97/104 (93.3%) patients, respectively. Patient-reported outcomes at 24 months were maintained at 5.8 years in patients who were not revised. Active MTP joint peak dorsiflexion was maintained. Ninety-nine of 106 (93.4%) patients would have the procedure again. CONCLUSION:: Clinical and safety outcomes for synthetic cartilage implant hemiarthroplasty observed at 2 years were maintained at 5.8 years. The implant remains a viable treatment option to decrease pain, improve function, and maintain motion for advanced hallux rigidus. LEVEL OF EVIDENCE:: Level IV, case series.

Association Between Patient Factors and Outcome of Synthetic Cartilage Implant Hemiarthroplasty vs First Metatarsophalangeal Joint Arthrodesis in Advanced Hallux Rigidus.

BACKGROUND: We evaluated data from a clinical trial of first metatarsophalangeal joint (MTPJ1) implant hemiarthroplasty and arthrodesis to determine the association between patient factors and clinical outcomes. METHODS: Patients ≥18 years with hallux rigidus grade 2, 3, or 4 were treated with synthetic cartilage implant MTPJ1 hemiarthroplasty or arthrodesis. Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) sports and activities of daily living (ADL) scores, and Short Form-36 Physical Function (SF-36 PF) subscore were obtained preoperatively, and at 2, 6, 12, 24, 52, and 104 weeks postoperatively. Final outcome data, great toe active dorsiflexion motion, secondary procedures, radiographs, and safety parameters were evaluated for 129 implant hemiarthroplasties and 47 arthrodeses. The composite primary endpoint criteria for clinical success included VAS pain reduction ≥30%, maintenance/improvement in function, no radiographic complications, and no secondary surgical intervention at 24 months. Predictor variables included hallux rigidus grade; gender; age; body mass index (BMI); symptom duration; prior MTPJ1 surgery; preoperative hallux valgus angle, range of motion (ROM), and pain. Two-sided Fisher exact test was used ( P < .05). RESULTS: Patient demographics and baseline outcome measures were similar. Success rates between implant MTPJ1 hemiarthroplasty and arthrodesis were similar ( P > .05) when stratified by hallux rigidus grade, gender, age, BMI, symptom duration, prior MTPJ1 surgery status, and preoperative VAS pain, hallux valgus, and ROM. CONCLUSION: Synthetic cartilage implant hemiarthroplasty was appropriate for patients with grade 2, 3, or 4 hallux rigidus. Its results in those with associated mild hallux valgus (≤20 degrees) or substantial preoperative stiffness were equivalent to MTPJ1 fusion, irrespective of gender, age, BMI, hallux rigidus grade, preoperative pain or symptom duration. LEVEL OF EVIDENCE: Level II, randomized clinical trial.

Correlation of Hallux Rigidus Grade With Motion, VAS Pain, Intraoperative Cartilage Loss, and Treatment Success for First MTP Joint Arthrodesis and Synthetic Cartilage Implant.

BACKGROUND: Grading systems are used to assess severity of any condition and as an aid in guiding treatment. This study examined the relationship of baseline motion, pain, and observed intraoperative cartilage loss with hallux rigidus grade. METHODS: A prospective, randomized study examining outcomes of arthrodesis compared to synthetic cartilage implant was performed. Patients underwent preoperative clinical examination, radiographic assessment, hallux rigidus grade assignment, and intraoperative assessment of cartilage loss. Visual analog scale (VAS) score for pain was obtained preoperatively and at 24 months. Correlation was made between active peak dorsiflexion, VAS pain, cartilage loss, and hallux rigidus grade. Fisher's exact test was used to assess grade impact on clinical success ( P < .05). RESULTS: In 202 patients, 59 (29%), 110 (55%), and 33 (16%) were classified as Coughlin grades 2, 3, and 4, respectively. There was no correlation between grade and active peak dorsiflexion (-0.069, P = .327) or VAS pain (-0.078, P = .271). Rank correlations between grade and cartilage loss were significant, but correlations were small. When stratified by grade, composite success rates between the 2 treatments were nearly identical. CONCLUSIONS: Irrespective of the grade, positive outcomes were demonstrated for both fusion and synthetic cartilage implant. Clinical symptoms and signs should be used to guide treatment, rather than a grade consisting of radiographic, symptoms, and range of motion factors. LEVEL OF EVIDENCE: Level II, randomized clinical trial.