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.

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.

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.

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.