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Bone & Joint Open
Vol. 5, Issue 9 | Pages 799 - 805
24 Sep 2024
Fletcher WR Collins T Fox A Pillai A

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


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_9 | Pages 1 - 1
16 May 2024
Brandao B Aljawadi A Fox A Pillai A
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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


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_7 | Pages 11 - 11
8 May 2024
Daniels T
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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


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_21 | Pages 19 - 19
1 Dec 2017
Goldberg A Glazebrook M Daniels T de Vries G Pedersen M Younger A Singh D Blundell C Sakellariou A Baumhauer J
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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


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_21 | Pages 17 - 17
1 Dec 2017
Davies H Blundell C Daniels T Glazebrook M Baumhauer J Younger A Le I Pedersen E
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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


The Bone & Joint Journal
Vol. 98-B, Issue 5 | Pages 634 - 640
1 May 2016
Pedowitz DI Kane JM Smith GM Saffel HL Comer C Raikin SM

Aims. Few reports compare the contribution of the talonavicular articulation to overall range of movement in the sagittal plane after total ankle arthroplasty (TAA) and tibiotalar arthrodesis. The purpose of this study was to assess changes in ROM and functional outcomes following tibiotalar arthrodesis and TAA. Patients and Methods. Patients who underwent isolated tibiotalar arthrodesis or TAA with greater than two-year follow-up were enrolled in the study. Overall arc of movement and talonavicular movement in the sagittal plane were assessed with weight-bearing lateral maximum dorsiflexion and plantarflexion radiographs. All patients completed Short Form-12 version 2.0 questionnaires, visual analogue scale for pain (VAS) scores, and the Foot and Ankle Ability Measure (FAAM). Results. In all, 41 patients who underwent TAA and 27 patients who underwent tibiotalar arthrodesis were enrolled in the study. The mean total arc of movement was 34.2° (17.0° to 59.1°) with an average contribution from the talonavicular joint of 10.5° (1.2° to 28.8°) in the TAA cohort. The average total arc of movement was 24.3° (6.9° to 44.3°) with a mean contribution from the talonavicular joint of 22.8° (5.6° to 41.4°) in the arthrodesis cohort. A statistically significant difference was detected for both total sagittal plane movement (p = 0.00025), and for talonavicular motion (p < 0.0001). A statistically significant lower VAS score (p = 0.0096) and higher FAAM (p = 0.01, p = 0.019, respectively) was also detected in the TAA group. Conclusion. TAA preserves more anatomical movement, has better pain relief and better patient-perceived post-operative function compared with patients undergoing fusion. The relative increase of talonavicular movement in fusion patients may play a role in the outcomes compared with TAA and may predispose these patients to degenerative changes over time. Take home message: TAA preserves more anatomic sagittal plane motion and provides greater pain relief and better patient-perceived outcomes compared with ankle arthrodesis. Cite this article: Bone Joint J 2016;98-B:634–40


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_19 | Pages 4 - 4
1 Nov 2016
Poh E Vasukutty N Pillai A
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Background. Cheilectomy and arthrodesis are accepted procedures for symptomatic hallux rigidus. Although good functional outcomes have been reported, there is little data available on post-operative sporting ability for these patients. Aims. We investigated sporting ability and functional outcomes of two cohorts of patients, the first underwent dorsal cheilectomy and the second arthrodesis. Methods. Physical and sporting ability was assessed using the Foot & Ankle Ability Measure (FAAM) sports questionnaire. Functional outcomes were assessed using MOXFQ. Radiological assessment was done according to Hattrup and Johnson classification. (HJ). Results. Group A (cheilectomy) consisted of 38 feet (35 patients) with a mean age of 57.2 (31–84) and mean follow-up 21.4 months (6–43). 21.6% were HJ1, 43.2% HJ2 and 35.1% HJ3. Group B (arthrodesis) consisted of 49 feet (47 patients) with a mean age of 64.1 (41–81) and mean follow-up 18.5 months (5–41). 6.8% were HJ1, 40.9% HJ2 and 52.3% HJ3. Mean FAAM score for group A was 78.89% (28.1%–100%). Mean FAAM score for group B was 81.55% (28.1%-100%). Mean MOXFQ score for group A was 14.89/64 (0–41). Mean MOXFQ score for group B was 10.43/64 (0–50). Pain, walking/standing and social domains were 29.74 (0–70), 21.8 (0–96.4) and 17.76 (0–68.8) in group A respectively. In group B, it was 14.79 (0–75), 16.54 (0–78.6), and 17.76 (0–100) respectively. FAAM was higher for group B in comparison to group A, but not statistically significant (P=0.425). Mean MOXFQ score was better in group B compared to group A (P< 0.05). Pain domain in particular was better in group B (P< 0.05). Conclusion. Our results suggest that both cheilectomy and arthrodesis for hallux rigidus result in similar post-operative sporting ability. Arthrodesis is superior to cheilectomy in overall functional outcomes, particularly in the pain domain


The Bone & Joint Journal
Vol. 99-B, Issue 9 | Pages 1183 - 1189
1 Sep 2017
Cho BK Kim YM Choi SM Park HW SooHoo NF

Aims

The aim of this prospective study was to evaluate the intermediate-term outcomes after revision anatomical ankle ligament reconstruction augmented with suture tape for a failed modified Broström procedure.

Patients and Methods

A total of 30 patients with persistent instability of the ankle after a Broström procedure underwent revision augmented with suture tape. Of these, 24 patients who were followed up for more than two years were included in the study. There were 13 men and 11 women. Their mean age was 31.8 years (23 to 44). The mean follow-up was 38.5 months (24 to 56) The clinical outcome was assessed using the Foot and Ankle Outcome Score (FAOS) and the Foot and Ankle Ability Measure (FAAM) score. The stability of the ankle was assessed using stress radiographs.