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Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 12 - 12
1 Mar 2021
Glazebrook M Baumhauer J Younger A Fitch D Quiton J Daniels T DiGiovanni C
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Autologous bone has been the gold standard for grafting material in foot and ankle arthrodesis. While autograft use has been effective, the harvest procedure does present risks to the patient including readmission, infection, and persistent graft harvest site pain. Previous studies have examined graft harvest site pain, but most have focused on the iliac crest and none have long term follow-up. The purpose of this study was to examine long-term (7–10 year) harvest site pain in subjects undergoing autograft harvest from multiple sites for hindfoot and/or ankle arthrodesis.

Sixty (60) subjects underwent hindfoot or ankle arthrodesis supplemented with autograft as part of the control arm of a prospective, randomized trial. The mean subject age was 59.4 years (range, 24.7–76.8) and mean body mass index was 30.6 kg/m2 (range, 22.0–44.0). There were 29 males and 31 female subjects. Subjects had the tibiotalar (37.9%), subtalar (24.1%), talonavicular (10.3%), subtalar/talonavicular (5.1%), or subtalar/calcaneocuboid/talonavicular (22.4%) joints arthrodesed. Autograft was harvested from either the proximal tibia (51.7%), iliac crest (17.2%), calcaneous (15.5%), distal tibia (6.8%), or other location (8.6%). Graft harvest site pain was evaluated using a 100-point visual analog score (VAS), with clinically significant pain being any score greater than 20.

Subjects were followed a mean of 9.0 years (range, 7.8–10.5). The percentage of subjects who reported clinically significant pain was 35.7%, 21.4%, 18.2%, 10.5%, 8.9%, and 5.2% at 2, 6, 12, 24, 52 weeks, and final follow-up (7.8–10.5 years), respectively. The mean VAS autograft harvest site pain at final follow-up was 4.4 (range, 0.0–97.0), with 37.9% of subjects reporting at least some pain. For three subjects (5%) with clinically significant pain (VAS >20) at final follow-up, two had proximal tibial harvest sites and one had an iliac crest harvest site. There was no correlation between graft volume and harvest site pain.

This study is the first to examine long-term pain following autologous bone graft harvest for hindfoot and/or ankle arthrodesis. Over a third of patients reported having some pain at an average follow-up of nine years, with 5% experiencing clinically significant pain. The results of this study suggest that harvesting autograft bone carries a risk of persistent, long-term pain regardless of the volume of graft that is harvested. This potential for persistent pain should be considered when informing patients of procedure risks and when deciding to use autograft or a bone graft substitute material.


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. 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. 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.