Aims. The Cartiva synthetic cartilage implant (SCI) entered mainstream use in the management of first metatarsophalangeal joint (MTPJ) arthritis following the positive results of large trials in 2016. Limited information is available on the longer-term outcomes of this implant within the literature, particularly when independent from the originator. This single-centre cohort study investigates the efficacy of the Cartiva SCI at up to five years. Methods. First MTPJ arthritis was radiologically graded according to the Hattrup and Johnson (HJ) classification. Preoperative and sequential postoperative patient-reported outcome measures (PROMs) were evaluated using the Manchester-Oxford Foot Questionnaire (MOXFQ), and the activities of daily living (ADL) sub-section of the Foot and Ankle Ability Measure (FAAM). Results. Patients were followed up for a mean of 66 months (SD 7.1). Of an initial 66 cases, 16 did not return PROM questionnaires. A total of six failures were noted, with survival of 82%. Overall, significant improvement in both objective scores (MOXFQ and FAAM ADL) was maintained versus preoperatively: 18.2 versus 58.0 (p > 0.001) and 86.2 versus 41.1 (p > 0.001), respectively. The improvement was noted to be less pronounced in males. Subjective scores had deteriorated since early follow-up, with an interval decrease in patient satisfaction from 89% to 68%. Furthermore, a subset of cases demonstrated clinically important interval deterioration in objective scores. However, no specific patient factors were found to be associated with outcomes following analysis. Conclusion. This study represents the longest-term independent follow-up in the literature. It shows reassuring mid-term efficacy of the Cartiva SCI with better-than-expected survival. However, deterioration in scores for a subset of patients and lower satisfaction may predict ongoing failure in this group of patients. Additionally, males were noted to have a lower degree of improvement in scores than females. As such, ongoing observation of the SCI to assess durability and survivability, and identify predictive factors, is key to improving patient selection. Cite this article: Bone Jt Open 2024;5(9):799–805

Introduction/Purpose. A randomized clinical trial of first MTP joint hemiarthroplasty with a synthetic cartilage implant demonstrated equivalent pain, function and safety outcomes to first MTP joint arthrodesis at 2 years. Recognizing that many hemiarthroplasty and total toe implants have initially good results that deteriorate over time, the purpose of this study was to prospectively assess the safety and efficacy outcomes for the synthetic cartilage implant population and to determine if the excellent outcomes were maintained at >5 years. Methods. One hundred nineteen patients were evaluated at 5+ years; 23 could not be reached for follow-up, but implant status was available for 7 of these subjects. Patients completed a pain visual analogue scale (VAS) and Foot and Ankle Ability Measure (FAAM) Sports and Activities of Daily Living (ADL) scores, preoperatively and at 2, 6, 12, 26, 52, 104 and 260 weeks postoperatively. Minimal clinically important differences are: ≥30% difference for pain VAS, 9 points for FAAM Sports, and 8 points for FAAM ADL. Great toe active dorsiflexion, weight-bearing radiographs, secondary procedures, and safety parameters were evaluated. Results. Of 119 patients available at mean 5.8 years follow-up (SD ±0.7; range: 4.4–8.0), 9 underwent implant removal and conversion to fusion in years 2–5, leaving 106 patients. The implant survival rate was 92.4% at 5.8 years. Pain and function outcomes at 5.8 years were similar to those at 2 years. VAS Pain, FAAM Sports, ADL Scores were maintained or improved at 5.8 years. No evidence of avascular necrosis, device migration or fragmentation was observed. There were no unanticipated safety events through 5.8 years. Ninety-three (93%) percent would have the procedure again. Conclusion. The synthetic cartilage hemiarthroplasty implant continues to demonstrate safety and efficacy for the treatment of advanced first MTP joint osteoarthritis with evidence of therapeutic effect and acceptable safety profile at 5.8 years

Objectives. Cartiva synthetic cartilage implant (SCI) is licenced for use in management of symptomatic hallux rigidus in several countries including the UK. As for now, there are no independent comparative series for treatment of hallux rigidus utilising polyvinyl alcohol implants. Study design and methods. Patients at a single centre with symptomatic hallux rigidus who underwent Cartiva SCI implant procedure 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 were evaluated using the Foot and Ankle Ability Measure (FAAM) activities of daily living subscale and the Manchester-Oxford Foot Questionnaire (MOXFQ). Results. 66 patients (19M, 47F) (43R and 23L) were followed up for an average of 14 months (min=2, max=36). 17 patients suffered from HJ2/moderate arthritis and 49 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 28 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. However clinically, males and older patients exhibit better outcomes. There was a 89.4% patient satisfaction with the use of Cartiva. Conclusions. Our study shows excellent results with statistically significant improvements in functional outcomes, and promising short-term follow-up with low early revision rates. Pain in particular was significantly reduced. One third of patients developed post-operative stiffness requiring a manipulation under anaesthesia. Patient selection is key. Additional imaging may be required to assess sesamoid osteoarthritis. At 3 years the implant has demonstrated to be safe and efficacious in the management of hallux rigidus. Durability and survivability of the implant will continue to be studied in this cohort

Introduction. A randomized clinical trial of first metatarsophalangeal (MTP) joint hemiarthroplasty with a synthetic cartilage implant demonstrated equivalent pain, function and safety outcomes to first MTP joint arthrodesis at 2 years. The implant cohort continues to be followed under an extension of the original study and we report on prospectively determined 5+ year outcomes for subjects assessed to date. Methods. Patients treated with hemiarthroplasty implant as part of the previously mentioned trial are eligible for enrollment in the extended study (n=135). At the time of this report, 57 patients had reached the 5+ years postoperative time point, of which 5 were lost to follow-up. The remaining 52 patients with mean age of 58.5 (range, 38.0–0.0) underwent physical examination, radiographic evaluation, assessment of implant survivorship and collection of patient completed VAS pain, and Foot and Ankle Ability Measure (FAAM) sports subscale and activities of daily living (ADL) subscale scores. Mean follow-up is 5.8 (range, 4.8–8.4) years. Results. Patient reported pain and function outcome measures showed clinically and statistically meaningful improvements over baseline at 5.8 years. Mean VAS pain scores decreased 57.9 points (86% pain reduction). The mean FAAM Sports and ADL subscale scores increased from baseline 47.9 points (126%) and 32.7 points (55%) respectively. Patients maintained first MTP joint motion with mean active peak MTP dorsiflexion of 25.9° (range, 0–0°) which was a 3° improvement from baseline. Implant survivorship at 5.8 years was 92%; four were converted to fusion because of persistent pain at mean time 42 months post-operation (range, 26–26 months). These results are equivalent to the outcomes reported at 2 years follow-up. 1. Conclusion. The synthetic cartilage hemiarthroplasty implant continues to demonstrate safety and efficacy for the treatment of advanced first MTP joint osteoarthritis with mid-term evidence of a therapeutic effect and an acceptable safety profile at 5.8 years

Patients with advanced stage hallux rigidus from 12 centers in Canada and the UK were randomized (2:1) to treatment with a small (8/10 mm) hydrogel implant (Cartiva) or 1. st. MTP arthrodesis. VAS pain scale, validated outcome measures (FAAM sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment and safety parameters were evaluated. 236 patients were initially enrolled, 17 patients withdrew prior to randomization, 17 patients withdrew after randomization and 22 were non-randomized training patients, leaving 152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were similar for both groups. Mean VAS pain scores decreased from 6.8 and 6.9 respectively for the implant and arthrodesis groups from baseline to 1.4 and 0.7 at 24 months. Similarly, the FAAM sports score improved significantly from baseline levels of 37 and 36 to 24 months level of 77 and 82 respectively for the implant and arthrodesis groups. First MTP active dorsiflexion motion improved an average of 4° at 3 months after implant placement and was maintained at 24 months. Secondary surgeries occurred in 17 (11.2%) implant patients and 6 (12.0%) arthrodesis patients. Fourteen (9.2%) implants were removed and converted to arthrodesis and 6 (12.0%) arthrodesis patients had painful hardware requiring removal. There was no case of implant fragmentation, wear, or bone loss. Analysis of a single composite endpoint utilizing the three primary study outcomes (pain, function, and safety) showed statistical equivalence between the2groups. Conclusion. In patients requiring surgery for advanced stage hallux rigidus, treatment with a small synthetic cartilage implant resulted in comparable clinically important pain relief and functional outcomes compared to 1. st. MTP arthrodesis while preserving and often improving great toe motion. Secondary surgical intervention was similar in the implant and arthrodesis groups. Revision from a small implant plug to arthrodesis can be performed if needed

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. Recently 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 largely based on a single cohort with mixed outcomes. We sought to evaluate the clinical outcomes of Cartiva SCI compared to arthrodesis undertaken in our centre. Methods. Retrospective review of patients undergoing Cartiva SCI or arthrodesis for treating hallux rigidus was conducted. Preoperative arthritis was radiographically graded using the Vanore classification. Patient reported outcomes (PROMs) were assessed using EuroQol 5-dimension score (EQ-5D-5L) and Manchester-Oxford Foot Questionnaire (MOXFQ). Results. Between 2017 and 2020 there were 33 cases (17 Cartiva, 16 arthrodesis, mean age 59.0±9.9 years) with a mean follow up of 2.3 years. For the first MTPJ arthrodesis cohort, the MOXFQ domain scores were: Index 3.9±5.8, Walking/Standing 5.1±7.6, Pain 3.2±5.0, and Social Interaction 2.6±4.0. EQ-5D-5L Index score was 0.828±0.270 and the EQ-VAS was 72.5±23.3. For the Cartiva cohort, the MOXFQ domain scores were: Index 7.7±6.0, Walking/Standing 8.9±7.9, Pain 7.1±5.0, and Social Interaction 6.4±5.4. EQ-5D-5L Index score was 0.631±0.234 and the EQ-VAS was 74.8±20.8. There was no statistically significant difference between any MOXFQ domain or EQ-5D-5L scores. However, a negative trend in MOXFQ domains was identified for the Cartiva group, as well as a reoperation rate of 23.5%. Conclusions. The Cartiva SCI demonstrated no advantage over arthrodesis in PROMs, despite the presumed benefit of preserved ROM. A significant reoperation rate was also observed. Surgeons should be cautious in the use of this novel implant

Introduction. Studies have compared outcomes of first metatarsophalangeal joint (MTPJ1) implant hemiarthroplasty and arthrodesis, but there is a paucity of data on the influence of patient factors on outcomes. We evaluated data from a prospective, RCT of MTPJ1 implant hemiarthroplasty (Cartiva) and arthrodesis to determine the association between patient factors and clinical outcomes. Methods. Patients ≥18 years with Coughlin hallux rigidus grade 2, 3, or 4 were treated with implant MTPJ1 hemiarthroplasty or arthrodesis. Pain VAS, Foot and Ankle Ability Measure (FAAM) Sports and ADL, and SF-36 PF scores were obtained preoperatively, and at 2, 6, 12, 24, 52 and 104 weeks postoperatively. Final outcomes, MTPJ1 active peak dorsiflexion, secondary procedures, radiographs and safety parameters were evaluated for 129 implant hemiarthroplasties and 47 arthrodeses. Composite primary endpoint criteria for clinical success included pain reduction ≥30%, maintenance/improvement in function, and no radiographic complications or secondary surgical intervention at 24 months. Predictor variables included: grade; gender; age; BMI; symptom duration; prior MTPJ1 surgery; preoperative hallux valgus angle, ROM, and pain. Two-sided Fisher's Exact test was used (p< 0.05). Results. Patient demographics and baseline outcome measures were similar. Success rates between implant MTPJ1 hemiarthroplasty and arthrodesis were similar when stratified by hallux rigidus grade, gender, age, BMI, symptom duration, prior MTPJ1 surgery status, and preoperative VAS pain, hallux valgus and ROM (p0.05). Conclusion. Synthetic cartilage implant hemiarthroplasty (Cartiva) is an appropriate treatment for patients with hallux rigidus grade 2, 3 or 4 and is a reasonable choice in hallux rigidus in patients with < 20 degrees HVA, with a high degree of preoperative stiffness, irrespective of gender, age, BMI, hallux rigidus grade, preoperative pain, or duration of symptoms, in contrast to what might have been expected

Introduction: Always more orthopaedic surgeons are nowadays putting all their efforts in improving knee osteochondral defects treatment. Material and Methods: In order to relieve patient symptoms we have retained of value, among other treatment options in use at our institution, to rely, in older patients, on a new, non biological, method of treating chondral and osteochondral defects and since November 2002 we started using artificial synthetic cartilage implants made of polyvinylalcohol-hydrogel (SaluCartilage™ – Salumedica). Results: Serial clinical and MRI follow-ups have been conducted. The 65 treated patients have shown significant improvement over preoperative values of 2000 International Knee Documentation Committee Knee Examination Forms. In fact at one year follow-up patients showed an average increase of 24 points over preoperative values of IKDC score, this improvement further raised up at the two year follow-up to a 33 points improvement (range of improvement 14,94 – 68,67) and has been confirmed at the three years evaluation. Follow-up MRI images revealed normal healing process, without signs of osteolysis or wear. No synovial joint reaction has been observed, but one case of implant’s dislocation occurred. Conclusions: Based on our mid term results, that have confirmed the short term ones, this study demonstrates that, in middle aged patients, between the fourth and the seventh decade, the use of a non biologic device, the implantation of a polyvinyl alcohol prosthesis in the chondral defect, represents an innovative treatment choice that knee surgeons need to be aware of and prompt to use it in the correct cases. In fact, in our opinion, the “chondral surgeon” must be ready to use different treatments in the different patients. To facilitate the use of Salucartilage ™ implant we suggest the rationale of it’s use with the auspice that surgeon’s experience and round tables will be able to better define the correct indications of each surgical possible solution of chondral defects. The immediate postoperative weight bearing and full regaining of recreational and sport activities are an added advantage of this technique that can be therefore when needed associated to other surgical procedures, such as osteotomies or ACL reconstructions

Although various treatment options are available, which include shaving, microfractures, abrasion arthroplasty osteochondral allografts and autografts, chondrocyte grafts and unicondylar prostheses, symptomatic articular cartilage defects represent a therapeutic challenge. Since November 2002, as a non-biological answer to the problem, we started using synthetic cartilage implants made of polyvinyl alcohol- hydrogel (PVA – H) (SaluCartilage). This is a transparent synthetic polymer with a molecular weight of 308,000 daltons and 20% of water content, available in cylindrical shape of various diameters. Following the second part of the OATS technique, under arthroscopic control and by mini-arthrotomy, or completely arthroscopically assisted, the cylindrical implant is inserted, using press-fit technique, into previously punched out and dilatated osteochondral defects. Our patients, whose mean age was 56 years (range 48–68 years) have been post-operatively reviewed clinically and by serial MRI exams. Patients showed significant improvement over pre-operative values in the IKDC score, with an average increase of 20 points. Follow-up MRI images revealed a normal healing process, without signs of osteolysis or wear. As complications we had one case of implant dislocation 1 year after surgery and one case of progressive loosening due to osteoarthritic disease, both of which have required a knee prosthesis. Our experience has led us to emphasise the use of this type of treatment only in cases that fullfil precise indications: (a) Third and fourth degree chondral or osteochondral symptomatic defects; (b) focal unicompartmental defects with 15 mm maximum extent; (c) patient’s age limited from fourth to seventh decade of life; and (d) absence of angular deformities or articular instabilities. The synthetic cartilage resurfacing technique has the advantages of no donor defect, one short-step surgical procedure, immediate weight-bearing and no extensive rehabilitation programme. Early results of first 15 patients are being presented, expecting a longer observation follow-up study