Cartiva interpositional arthroplasty versus arthrodesis in the treatment of Hallux rigidus: A retrospective comparative study with mean 2 year follow up.

BACKGROUND: Hallux rigidus is a common condition characterised by first metatarsophalangeal joint (MTPJ) degeneration, pain and limited range of motion (ROM). The gold standard surgical treatment is arthrodesis, providing good pain relief, but sacrifices ROM. The Cartiva synthetic cartilage implant (SCI) has been utilised as an interpositional arthroplasty, aiming to reduce pain whilst preserving range of motion. Current evidence for Cartiva SCI is limited. The aim was to evaluate the clinical outcomes of Cartiva SCI compared to arthrodesis undertaken in our centre. METHODS: A retrospective cohort study was conducted, enrolling all adult patients who underwent primary first MTPJ SCI arthroplasty or arthrodesis for the treatment hallux rigidus. The primary outcome was a validated patient-reported outcome measure (PROM), the Manchester-Oxford Foot Questionnaire (MOXFQ). Secondary outcomes included EQ-5D, complication rates, VAS Pain and FAAM (ADL). RESULTS: Between 2017 and 2020 there were 33 cases divided into two groups (17 Cartiva SCI, 16 arthrodesis, mean age 59.0 ± 9.9 years) with a mean follow up of 2.3 years. There was no statistically significant difference in any of the MOXFQ, EQ-5D, VAS Pain or FAAM (ADL) outcome scores between the Arthrodesis and SCI groups (p > 0.05). The mean MOXFQ Index score was 7.2 ± 6.4 for the SCI group and 3.9 ± 5.8 for the Arthrodesis group at final follow up (p = 0.15). Although complications were high in both groups, the overall hallux reoperation rate was 29.4 % in the SCI cohort and 0.0 % for arthrodesis. CONCLUSION: This retrospective comparative study found no significant superiority of Cartiva SCI over arthrodesis in terms of PROMs. Due to the higher rate of further surgical intervention in the SCI cohort, we recommend arthrodesis as the preferred surgical option for hallux rigidus. LEVEL OF EVIDENCE: III.

Arthrodesis vs arthroplasty for moderate and severe Hallux rigidus: Systematic review.

Hallux rigidus is the most frequent arthritis of the foot, due to multiple factors. Arthrodesis and interposition arthroplasty are treatments considered in advanced stages of the disease, when conservative treatment has failed. Although arthrodesis may be considered the technique recommended by multiple authors, for patients in whom joint mobility is to be preserved, arthroplasty could represent a reliable alternative. The purpose of this systematic review is to investigate and compare the clinical outcomes and complications of arthrodesis and interposition arthroplasty for moderate and severe stages of hallux rigidus. METHODS: For this systematic review we searched COCHRANE, EMBASE, PUBMED databases. Twenty-six research papers were obtained, with a total of 1348 feet, which were included for qualitative analysis. The following groups were included: Cartiva hemiarthroplasty (286), double stem silicone arthroplasty (276), total metallic arthroplasty (394) and arthrodesis (392). RESULTS: In the arthrodesis group, the AOFAS-HMI score was the most used, ranging from 36 to 45 in the preoperative period and from 79 to 89 in the postoperative period. The greatest improvement in the VAS PAIN score was from 86 to 4. The fusion rate was 98.6% of the total number of cases, the most frequent complication was pain due to material discomfort. In the total metallic arthroplasty group, the ROTO-GLIDE system reported an AOFAS score of 95 points, with low complication rates; but, with the TOEFIT-PLUS and BIOMED-MERCK systems, despite the good postoperative value, they report 37% and 15% revision due to aseptic loosening in the series with the longest follow-up, respectively. The Cartiva group showed a significative increase in FAAM ADL and FAAM SPORT from 59.4 to 90.4 and from 60.9 to 89.7, respectively; similarly, 20.5% implant removal and conversion to arthrodesis were reported. Finally, the double stem silicone arthroplasty group, in the series with the longest follow-up, it manages to improve the MOXFQ score from 78.1 to 11.0, with an average range of mobility of 22.3 degrees. Lysis was reported in 10% of cases. CONCLUSIONS: Arthrodesis has proven to be the best option for the treatment of advanced hallux rigidus. Arthroplasty can be a valid option for patients who demand to maintain the range of mobility of the joint; however, it is important to inform about the complications that may arise in the short and medium term. LEVEL OF CLINICAL EVIDENCE: II.

Synthetic cartilage implant hemiarthroplasty versus cheilectomy for the treatment of hallux rigidus.

Degenerative arthritis of the first metatarsophalangeal joint, hallux rigidus, is the most common type of arthritis of the foot, affecting nearly 2.5% of the population over the age of 50. Hallux rigidus can be treated surgically with either Cheilectomy or Synthetic cartilage implant (SCI) hemiarthroplasty. The purpose of this study is to compare outcomes from a single institution on the treatment of hallux rigidus using cheilectomy and SCI hemiarthroplasty. Between 2012 and 2020, 49 patients underwent either a SCI (Polyvinyl alcohol hydrogels) hemiarthroplasty or Cheilectomy for the treatment of hallux rigidus. Functional scores were assessed pre and postoperatively using the American Orthopedic Foot and Ankle scoring System (AOFAS) and the Foot and Ankle Outcome Score survey (FAOS). Plantar and Dorsal range of motion was also assessed pre and postoperatively. Outcomes, complications, and any reoperations were recorded for all patients. Mean pre-op AOFAS for Cheilectomy and SCI were 49.6 and 54.8, respectively, compared to 85.3 and 89.7, respectively, after surgery (p value < 0.05). Mean pre-op Dorsal range of motion (ROM) for Cheilectomy and SCI were 24.0 and 26.0 degrees, respectively, compared to 38.0 and 42.6 degrees, respectively, after surgery (p value < 0.05). SCI hemiarthroplasty patients had higher AOFAS and dorsal ROM at the latest follow up (p value < 0.05). Synthetic cartilage implant (SCI) hemiarthroplasty and cheilectomy both offer promising results and remain viable treatment options to decrease pain, improve function, and maintain motion for hallux rigidus. SCI hemiarthroplasty may offer superior range of motion and functional outcomes than cheilectomy for hallux rigidus. LEVEL OF CLINICAL EVIDENCE: 3.

Description of a Revision Technique for Failed Polyvinyl Alcohol Hydrogel Implant in Patient with Freiberg's Disease.

Polyvinyl alcohol hydrogel synthetic cartilage implants are increasingly used to treat advanced Freiberg disease. We report a case with recurrence of symptoms within 6 weeks and required revision for fracture of the implant. We describe a revision technique with modified osteochondral bone graft to deal with the variables of revision surgery namely: the bone loss, collateral ligament insufficiency, and changes to the proximal phalanx articular surface. We describe a postoperative plan, recovery and a good outcome achieved in 12 month follow-up.

Adverse events involving hallux metatarsophalangeal joint implants: Analysis of the United States Food and Drug Administration data from 2010 to 2018.

BACKGROUND: The prevalence of osteoarthritis of the hallux metatarsophalangeal joint (MTPJ) is 1 in 40 people over the age of 50. Surgical treatment options for MTPJ arthritis include joint preservation, joint resurfacing, and arthrodesis. Hallux MTPJ implants have evolved over the past several decades, but are associated with various complications. The aim of this study was to examine the MAUDE database to determine reported adverse events for hallux MTPJ implants. MATERIALS AND METHODS: The US Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2010 to 2018 to review voluntary reported adverse event reports for approved implants within the United States. We recorded the type of adverse event and excluded duplicate reports and those extracted from already published literature. RESULTS: Among 64 reported hallux MTPJ implant adverse events, the most common modes of adverse events were component loosening (34%), infection (14.1%), component fracture (9.4%), inflammation (9.4%), and allergic reaction (7.8%). Regarding implant type, Cartiva SCI had the highest percentage of adverse events (23.4%), followed by Arthrosurface ToeMotion (20.3%), Ascension MGT (12.5%), Arthrosurface HemiCAP® (10.9%), Futura primus (9.4%), and Osteomed Reflexion (6.3%). There was an increase in reported adverse events after 2016. The MAUDE database does not report the total incidence of implant insertion. CONCLUSION: Our study of the MAUDE database demonstrated that component loosening and infection are the most common modes of adverse events for hallux MTPJ implants. Cartiva accounted for one-fourth of the implant-related adverse events during our study period, followed by ToeMotion, and Ascension MGT implants. Continued reporting of adverse events will improve our understanding on short and long-term complications of various hallux MTPJ implants. LEVEL OF EVIDENCE: Level IV; Case Series from Large Database Analysis; Treatment Study.

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.

Motion Preservation in Hallux Rigidus After Failure of Hydrogel Implantation: Treatment Considerations and a Report of 2 Cases.

Hallux rigidus is a common condition treated daily by surgeons worldwide. During the past decade, the standard treatment algorithm has been questioned by both patients and surgeons seeking alternatives to arthrodesis, which was previously considered the gold standard for advanced disease. Patients are living longer, and many have a more active lifestyle; thus, recreating and improving range of motion and achieving pain relief are increasingly desirable. The treatment spectrum and implant options for motion-preserving techniques in the metatarsophalangeal joint has been widened with the recent US Food and Drug Administration approval of a polyvinyl-alcohol hydrogel implant. In the controlled US Food and Drug Administration trial, the 2-year revision rate was 9.2% and all failures were revised to a first metatarsophalangeal arthrodesis. Outcomes comparison of these revisions to primary fusions showed less predictable pain relief and may warrant alternative treatment considerations, preferably those that allow for continuation of motion preservation. Revision of failed hydrogel implants to arthrodesis can be performed through various first metatarsophalangeal fusion techniques or, as introduced in this review, with a fourth-generation threaded hemiarthroplasty. Excellent 10-year results with primary hemiarthroplasty supported its use as revision procedure in 2 failed polyvinyl-alcohol implantations, preserving arthrodesis for future salvage if necessary. The purpose of this report was to outline a motion-preserving technique after failed hydrogel implants and describe preoperative, intraoperative, and postoperative considerations for optimized outcomes.

Cartiva: A Review of the Best Evidence.

The Cartiva implant is a synthetic polyvinyl alcohol hydrogel cartilage substitute that is used as a treatment of first metatarsophalangeal joint arthritis. The implant was designed to relieve the pain associated with hallux rigidus while preserving or restoring range of motion. A summary of outcomes, reasons for these outcomes, and technique pearls will be reviewed here. Seminal articles and current evidence are all included in this article. The aim is for the surgeon to understand all the literature, allowing the surgeon to counsel their patients appropriately, optimize patient selection and to deal with complications.

Surgical Management of Failed First Metatarsophalangeal Joint Arthroplasty.

This article describes the etiology, clinical presentation, surgical management, and outcomes for treatment of the failed first metatarsophalangeal (MTP) joint arthroplasty. Failure following implant arthroplasty typically creates large osseous deficits and surgical management can be difficult. Salvage arthrodesis provides reliable joint stability while maintaining hallux length. Outcomes following conversion of a failed MTP joint arthroplasty to MTP joint arthrodesis have demonstrated consistent pain relief and high satisfaction: however, high rates of complication and nonunion have been reported. Bone graft may be necessary to fill large voids in the joint. Other revision options for failed arthroplasty have been described, but outcomes remain inconsistent and varied. Ultimately, conversion to MTP joint arthrodesis is the recommended intervention for treatment of the failed MTP arthroplasty implant, providing sufficient stability and pain relief.

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.

The Use of a Synthetic Cartilage Implant for Hallux Rigidus: A Systematic Review.

Background. Hallux rigidus is a common pathology afflicting the foot, for which various joint salvage techniques have been described with a multitude of different implants. Recently, a synthetic cartilage implant composed of polyvinyl alcohol (PVA) received FDA premarket approval for the treatment of arthritis of the great toe. The purpose of this study was to (1) systematically review the clinical evidence supporting the use of a PVA implant in hallux rigidus and (2) determine the strength of the recommendation that can be made supporting the use of a PVA implant by evaluating the quality of evidence available. Methods. A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. Using the terms "cartiva OR polyvinyl alcohol OR synthetic cartilage OR hemiarthroplasty AND hallux rigidus OR great toe arthritis OR first toe arthritis" we searched the PubMed/Medline database. The quality of the included studies was evaluated using the American Academy of Orthopaedic Surgeons Clinical Practice Guideline and Systematic Review Methodology. Results. Seven studies met the inclusion criteria, 6 of these were derived from a single randomized controlled trial. A moderate recommendation can be given for the use of a PVA implant for hallux rigidus based on short-term outcomes. A limited recommendation can be given for the use of a PVA implant for hallux rigidus based on mid-term outcomes. Conclusion. There are limited studies available detailing the outcomes of a PVA implant for hallux rigidus; however, the results that are available demonstrate a high level of evidence.Levels of Evidence: Level I: Systematic review.

Joint sparing management of hallux rigidus: Cartiva SCI vs cheilectomy a comparative review.

BACKGROUND: Hallux rigidus, or first metatarsophalangeal joing arthritis, is a very common condition which causes pain and loss of motion in the joing which can be debilitating. METHODS: Patient reported outcome measures were utilised to study the difference in day to day functionality between two common surgical management options for hallux rigidus. RESULTS: 55 Cartiva and 23 Cheilectomy patients were included in this study. The Manchester Oxford Foot and Ankle Questionnaire revealed statistically significant improvements in the cheilectomy patients when compared to Cartiva SCI.Foot and Ankle Ability Measure found no statistical difference was found between the two surgical treatments. CONCLUSION: Cheilectomy offers good post-operative functional and sporting outcomes after surgery for the management of hallux rigidus at 5 years.

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.

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

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.

Comparison Between Polyvinyl Alcohol Implant and Cheilectomy With Moberg Osteotomy for Hallux Rigidus.

BACKGROUND: In 2016, the US Food and Drug Administration (FDA) approved the use of a polyvinyl alcohol (PVA) hydrogel implant for the surgical management of hallux rigidus. Though recent studies have evaluated the safety and efficacy of the implant, no study has compared outcomes following PVA implantation with those following traditional joint-preserving procedures for hallux rigidus, such as cheilectomy with Moberg osteotomy. The purpose of this study was to compare clinical and patient-reported outcomes for patients undergoing cheilectomy and Moberg osteotomy, with or without PVA implant, at a single multisurgeon academic center. Our hypothesis was that the addition of the PVA implant would result in superior clinical and patient-reported outcomes. METHODS: In total, 166 patients were identified who underwent cheilectomy and Moberg osteotomy with (PVACM; n = 72) or without (CM; n = 94) a PVA implant between January 2016 and December 2018 by 1 of 8 foot and ankle fellowship-trained orthopedic surgeons at our institution. Of these patients, 60 PVACM and 73 CM patients had both baseline and minimum 1-year postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores. The average time to survey follow-up was 14.5 months for PVACM patients and 15.6 months for CM patients. Retrospective chart review was performed to assess the incidence of postoperative complications and reoperations, with an average clinical follow-up of 27.7 (range, 16.0-46.4) months for PVACM patients and 36.6 (range, 18.6-47.8) months for CM patients. RESULTS: Both PVACM and CM cohorts demonstrated significant improvement in the PROMIS Physical Function, Pain Interference, Pain Intensity, and Global Physical Health domains when comparing preoperative and postoperative scores within each group (P < .01). When comparing scores between the PVACM and CM cohorts, preoperative scores were similar, while CM patients demonstrated significantly higher postoperative Physical Function (51.8 ± 8.7 vs 48.8 ± 8.0; P = .04) and significantly lower Pain Intensity (39.9 ± 8.3 vs 43.4 ± 8.7; P = .02) scores. The pre- to postoperative change in Physical Function was also significantly greater for CM patients (7.1 ± 8.5 vs 3.6 ± 6.2; P = .011). In the PVACM group, there were 3 revisions (5%), 1 reimplantation, 1 conversion to arthrodesis, and 1 revision to correct hyperdorsiflexion. In the CM group, there was 1 revision (1.4%), a conversion to arthrodesis (P = .21). Other postoperative complications included persistent pain (7 out of 60 PVACM patients [11.7%] and 8 out of 73 CM patients [11.0%]; P = .90) and infection in 3 PVACM patients (5%) and no CM patients (P = .05). CONCLUSION: Though our results generally support the safety and utility of the PVA implant as previously established by the clinical trial, at 1 to 2 years of follow-up, CM without a PVA implant may provide equivalent or better relief compared with a PVACM procedure, while avoiding potential risks associated with the implant. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

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.

Clinical Outcomes of the Polyvinyl Alcohol (PVA) Hydrogel Implant for Hallux Rigidus.

BACKGROUND: Hallux rigidus is a common arthritic condition that has been addressed surgically with a range of techniques, from an isolated cheilectomy to first metatarsophalangeal (MTP) joint fusion. Recently, hemiarthroplasty with polyvinyl alcohol (PVA) hydrogel implant has been used as an alternative treatment to relieve pain while preserving motion of the first MTP joint. We retrospectively reviewed patient-reported outcome scores and clinical outcomes for patients treated for hallux rigidus with PVA hydrogel implant at an academic, multisurgeon center. METHODS: A total of 103 patients who underwent first MTP hemiarthroplasty with PVA hydrogel implant between January 2017 and October 2018 were retrospectively reviewed (average, 26.2 months). Eight surgeons were represented. Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) scores for the Physical Function, Pain Interference, Pain Intensity, Global Physical Health, Global Mental Health, and Depression domains were collected prospectively and compared with PROMIS scores collected at a minimum of 1 year postoperatively (average, 13.9 months). Seventy-three patients had both preoperative and postoperative scores. Ten of these patients had undergone a prior procedure of the first MTP, and 52 underwent concurrent Moberg osteotomy at the time of PVA hydrogel implantation. RESULTS: For patients with baseline and postoperative PROMIS scores, significant pre- to postoperative improvement was detected for the Physical Function, Pain Interference, Pain Intensity, and Global Physical Health domains (P < .05). Patients who had undergone a prior procedure of the first MTP had significantly higher postoperative Pain Intensity scores compared with those who did not undergo a prior procedure. Patients undergoing concurrent Moberg osteotomy had significantly lower postoperative Pain Interference and Pain Intensity scores compared with those who did not undergo a Moberg. Two patients underwent revision procedures in the first 2 years postoperatively, one with revision hemiarthroplasty and one with conversion to arthrodesis. CONCLUSION: On average across our entire cohort, physical function and pain scores improved significantly pre- to postoperatively; however, postoperative pain scores were significantly higher for patients who had undergone a prior procedure of the first MTP and significantly lower for patients who underwent concurrent Moberg osteotomy. The implant displayed excellent survivorship in the first 2 years postoperatively, with only 2 revision procedures. LEVEL OF EVIDENCE: Level III, comparative series.

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.