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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).


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.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_9 | Pages 3 - 3
16 May 2024
Sinan L Kokkinakis E Kumar CS
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Introduction

Cheilectomy is a recommended procedure for the earlier stages of osteoarthritis of the 1st metatarsophalangeal joint. Although good improvement in symptoms have been reported in many studies, the long term performance of this procedure is not well understood. It is thought that a significant number of patients go onto have arthrodesis or joint replacement. We report on a large cohort of patients who received this procedure and report on the complications and mid-term outcome.

Methods

This is a retrospective study looking at all patients who underwent cheilectomy for hallux rigidus between November 2007 and August 2018. Departmental database was used to access patient details and outcome measures recorded include: postoperative wound infection, patient reported improvement in pain and the incidence of further surgical interventions like revision cheilectomy and conversion to arthrodesis and arthroplasty. X-rays were studied using PACS to stage the osteoarthritis (Hattrup and Johnson classification).


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_11 | Pages 23 - 23
4 Jun 2024
Trowbridge S Lewis T Shehata R Lau B Lyle S Ray R
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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).


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_14 | Pages 24 - 24
1 Dec 2015
McEntee L Killen M Karpe P Limaye R
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Background

Hallux rigidus is a degenerative condition of the first metatarsophalangeal joint (MTPJ) of the great toe, which can result in significant pain and stiffness. Treatment using joint replacement, either by means of hemiarthroplasty or total arthroplasty of the metatarsophalangeal joint is becoming an increasingly popular option for patients with severe disease.

Aim

To evaluate mid-term functional and radiological outcomes of a widely used first generation resurfacing arthroplasty system in the treatment of hallux rigidus.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXII | Pages 33 - 33
1 May 2012
Dawe E Ball T Annamalai S Davis J
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Minimally Invasive foot surgery remains controversial

Potential benefits include a reduced incidence of wound complications, faster return to employment and normal footwear. There are no studies published regarding the results of minimally invasive dorsal cheilectomy.

Patients and Methods

Thirty eight patients with painful grade I hallux rigidus underwent dorsal cheilectomy between April 2006 and June 2010. Minimally invasive cheilectomy (MIC) was introduced in August 2009. AOFAS scores, satisfaction, return to normal shoes and employment were assessed.


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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIII | Pages 15 - 15
1 Sep 2012
Morgan S Khan K Clough T
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Background

Short term results of silastic implant of first MTPJ are successful. However reservations exist regarding long term results. The aim of this study is to evaluate long term outcome of silastic implant prosthesis in treatment of hallus rigidus.

We reviewed 108 feet in 83 patients who were operated on between 1988 and 2003. Mean age at operation = 55(SD 8.1). Mean follow up = 8.31 years (SD 3.3). Patients were assessed using the American Orthopaedic Foot and Ankle Scoring system (AOFAS). Passive and active arc of motion were measured. To assess patients' satisfaction they are asked if they would repeat the procedure and also using a visual analogue scale (VAS) to express their overall satisfaction with the outcome. All the patients had anteroposterior and oblique views. Radiographs were assessed for loosening and osteolysis.

Results

Median AOFAS = 81(IQR = 15). Median VAS = 8(IQR = 3). Median active arc of motion = 35(IQR 18). Passive arc of motion = 46(IQR = 23). No significant difference in results was found in patients with associated hallux valgus (p value = 0.6). There was significant correlation between the AOFAS and VAS (Pearson correlation = 0.58, p value <.0001). No correlation was found between AOFAS, VAS and radiological changes (P value = 0.8 and 0.9 respectively). In 83 feet (76.9%) patients reported “yes” that they would repeat the procedure and in 22(20.4%) feet patients reported “no”. Prosthesis were removed in three feet at three, five and seven years respectively because of persistent pain. Radiologically, 58% showed cyst formation but didn't correlate with functional outcome.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_21 | Pages 18 - 18
1 Dec 2017
Ring J Clough T
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Introduction

Arthroplasty for treatment of end stage hallux rigidus is controversial. Arthrodesis remains the gold-standard, but this procedure is not without complications, with up to 10% non-union, 14% re-operation and 10% transfer metatarsalgia rates reported.

The aim of this study was to analyse the outcome of the double-stemmed silastic implant (Wright-Medical) for end stage hallux rigidus.

Method

We conducted a retrospective review of a consecutive series of 108 silastic 1st MTPJ implanted in our Unit (January 2005 – December 2016). Data was collected from our research databases, patient notes, PACS and PROMS. No patient was lost to follow-up.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_14 | Pages 25 - 25
1 Dec 2015
Dall G Clement N McDonald D Ahmed I Duckworth A Shalaby H McKinley J
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We present a review of 97 consecutive BioPro® metallic hemiarthroplasties performed in 80 patients for end-stage hallux rigidus, with a minimum of five years follow-up.

The mean age of the cohort was 55 (22 to 74) years. No patient was lost to follow-up. There were 15 revisions performed, one for infection, two for osteolysis, and 12 for pain. The all cause survival rate at five years was 85.6% (95% confidence interval (CI) 83.5 to 87.9). Younger age was a significant predictor of revision (odds ratio 1.09, 95% CI 1.02 to 1.17, p=0.014) on excluding infection and adjusting for confounding variables (Cox regression). Significant improvements were demonstrated at 5 years in the Manchester Oxford foot questionnaire (13.9, 95% CI 10.5 to 17.2) and in the physical component of the short form 12 score (6.5, 95% CI 4.1 to 8.9). The overall satisfaction rate was 72%. The cost per quality-adjusted-life-year at 5 years, accounting for a 3% per year revision rate, was £3,714.

The BioPro offers good short to mid-term functional outcome and is a cost effective intervention. The relative high revision rate is associated with younger age and the use of this implant may be limited to older patients.


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).


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_14 | Pages 26 - 26
1 Dec 2015
Baumhauer J Singh D Glazebrook M Blundell C Wansbrough G de Vries G Le I Nielson D Petersen E Sakellariou A Solan M Younger A Daniels T
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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 1st 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 1st 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.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_21 | Pages 32 - 32
1 Apr 2013
Al-Maiyah M Rice P Schneider T
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Introduction. Hallux Rigidus affects 2–10% of population, usually treated with cheilectomy or arthrodesis, however, for the subclass of patients who refuse to undergo fusion, Arthroplasty is an alternative solution, it maintain some degree of motion and provide pain relief. Toefit; is one of the prostheses being used. It is a total joint replacement with polyethylene insert. The aim of this study is to find clinical and radiological outcomes of Toefit arthroplasty. Method. A prospective study. Ethical committee approval was obtained. Patient who have received Toefit Arthroplasty with at least 12 months follow-up and were willing to participate in the study were included. Patients were reviewed by independent surgeon. Questionnaires were completed followed by clinical examination. This followed by radiographic assessment. Patients, who were willing to take part in the study but could not attend a clinical review, were invited to participate in telephone questionnaire. Pre and postoperative AOFAS scores were compared, patients' satisfaction and clinical and radiological outcome were assessed using descriptive statistics, t-test and survivalship analysis were done. Results. 180 patients had Toefit (September 2004–June 2011). 160 patients participated in the study (170 prostheses), 87% were females. Age range (38–89) year. AOFAS improved significantly from 38 to 83, with average arc of movement of 37 degrees. Patient satisfaction was high, VAS score1. Failure rate of 4.9%, there was high rate of revision of 29% due to sesamoid pain or stiffness in the initial group of patients, decreased to 8% in the second group. Radiological review showed asymptomatic aseptic loosening of 20%, mainly of the proximal phalanx components. Conclusion. First MTP joint replacement can provide pain relief and maintain good range of movement. However, this study highlighted high rate of revision and aseptic loosening. Long term review is required