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The Bone & Joint Journal
Vol. 98-B, Issue 7 | Pages 945 - 951
1 Jul 2016
Clement ND MacDonald D Dall GF Ahmed I Duckworth AD Shalaby HS McKinley J

Aims. To examine the mid-term outcome and cost utility of the BioPro metallic hemiarthroplasty for the treatment of hallux rigidius. Patients and Methods. We reviewed 97 consecutive BioPro metallic hemiarthroplasties performed in 80 patients for end-stage hallux rigidus, with a minimum follow-up of five years. There were 19 men and 61 women; their mean age was 55 years (22 to 74). No patient was lost to follow-up. Results. A total of 12 patients (15 first metatarso-phalangeal joints (MTPJs)) required a revision; one for infection, two for osteolysis and 12 for pain. The all cause rate of survival 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 five 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 rate of satisfaction was 75%. The cost per quality adjusted life year at five years, accounting for a 14% rate of revision was between £4431 and £6361 depending on the complexity and morbidity of the patient. Conclusion. The BioPro hemiarthroplasty offers good short to mid-term functional outcome and is a cost effective intervention. The relatively high revision rate is associated with younger age and perhaps the use of this implant should be limited to older patients. Cite this article: Bone Joint J 2016;98-B:945–51


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


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. Method. Prospective review of patients from 2009 onwards. All patients were operated on by the senior author using the same first generation hemiarthroplasty prosthesis (HemiCAP®, Arthrosurface, USA) and surgical technique. Radiological and clinical outcomes were assessed at 3, 6, 12 and 24 months post-operatively. Patients were assessed pre- and post-operatively on an outpatient basis for MTPJ range of motion as well as outcomes using AOFAS and visual analogue scale scores. Results. 20 prostheses in 19 patients over a two year period. Mean follow-up was 18 months (range 12–24). Mean AOFAS score improved from 38.66 pre-operatively to 74.93 at 12 months post-operatively. Mean VAS score improved from 9.95 pre-operatively to 4.05 post-operatively. There was radiological subsidence in one patient. 5 patients (26%) required revision to arthrodesis due to ongoing pain and stiffness. Conclusion. Despite significant improvements in functional scores and positive radiological outcomes in most patients, we have seen high revision rates with this first generation prosthesis due to ongoing pain and stiffness. Since this study, there has been a redesign of this implant with the addition of a dorsal flange, but the first generation prosthesis still remains in use. Following our results, we have discontinued our use of this product in favour of either the newer generation hemiarthroplasty or total arthroplasty system for patients with severe hallux rigidus


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. 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. 94-B, Issue SUPP_XXII | Pages 5 - 5
1 May 2012
Saltzman C
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Fusion remains the standard of care and is associated with a high satisfaction rate. But.… fusion generally requires 6 weeks of restricted weight bearing or immobilization. Potential problems include 1) nonunion, 2) malunion, 3) sesamoid pain (from DJD), 4) late onset IP1 DJD.

Complete joint replacement has been performed with a number of different designs since the early 1970's. The metal and poly designed implants are associated with a high failure rate, presumably from high shear loads, eccentric axial loads, poor fixation and bone stock problems. Resurfacing of both sides of the joint with a one piece silicone based crosslinked rubber {“silastic”} in rheumatoid patients appears to function better with use of metal grommets to reduce generation of particle debris and foreign body reaction. These silastic implants are still used by surgeons in select low-demand rheumatoid patients. Salvage after failure of any of these total joint replacements can be challenging because of loss of bone stock.

3 other methods are used to resurface the joint in severe OA: 1) resurfacing the proximal phalangeal side only, 2) resurfacing the metatarsal head only and 3) resurfacing the joint with and interposition arthroplasty. 1) advantage of the proximal phalangeal side resurfacing is simplicity of geometry; the disadvantage is disruption of the FHB attachment and the relative scarcity of severe cartilage damage at that side of the joint. 2) Advantage of the metatarsal head side for resurfacing is that is the typical location of the arthritic change; the disadvantage is potential interference with the sesamoid complex and bulkiness of fixation could lead to a more difficult salvage. 3) The advantage of interposition arthroplasty is the maintenance of bone stock; disadvantages include inconsistent local tissue and somewhat less predictable outcomes.

In this talk I will focus primarily on the technique and results of a proximal phalangeal resurfacing approach for OA of the MTP1 joint.


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


The Bone & Joint Journal
Vol. 102-B, Issue 2 | Pages 220 - 226
1 Feb 2020
Clough TM Ring J

Aims

Arthroplasty for end-stage hallux rigidus (HR) is controversial. Arthrodesis remains the gold standard for surgical treatment, although is not without its complications, with rates of up to 10% for nonunion, 14% for reoperation and 10% for metatarsalgia. The aim of this study was to analyze the outcome of a double-stemmed silastic implant (Wright-Medical, Memphis, Tennessee, USA) for patients with end-stage HR.

Methods

We conducted a retrospective review of 108 consecutive implants in 76 patients, between January 2005 and December 2016, with a minimum follow-up of two years. The mean age of the patients at the time of surgery was 61.6 years (42 to 84). There were 104 females and four males. Clinical, radiological, patient reported outcome measures (PROMS) data, a visual analogue score (VAS) for pain, and satisfaction scores were collected.


The Bone & Joint Journal
Vol. 98-B, Issue 10 | Pages 1376 - 1381
1 Oct 2016
Bucknall V Rutherford D MacDonald D Shalaby H McKinley J Breusch SJ

Aims

This is the first prospective study to report the pre- and post-operative patient reported outcomes and satisfaction scores following excision of interdigital Morton’s neuroma.

Patients and Methods

Between May 2006 and April 2013, we prospectively studied 99 consecutive patients (111 feet) who were to undergo excision of a Morton’s neuroma. There were 78 women and 21 men with a mean age at the time of surgery of 56 years (22 to 78). Patients completed the Manchester-Oxford Foot Questionnaire (MOXFQ), Short Form-12 (SF-12) and a supplementary patient satisfaction survey three months pre-operatively and six months post-operatively.