Mark Glazebrook1, Chris M Blundell2, Dominic O'Dowd2, Dishan Singh3, Gwyneth de Vries4, Ian L D Le5, Dominic Nielsen6, M Elizabeth Pedersen7, Anthony Sakellariou8, Matthew Solan9, Guy Wansbrough10, Alastair S E Younger11, Judith F Baumhauer12, Timothy R Daniels13. 1. 1 Dalhousie University and Queen Elizabeth II Health Sciences Center, Halifax, NS, Canada. 2. 2 Northern General Hospital, Sheffield, UK. 3. 3 Royal National Orthopaedic Hospital, Stanmore, Middlesex, UK. 4. 4 Dalhousie University and Memorial University of Newfoundland, Fredericton, NB, Canada. 5. 5 University of Calgary, Calgary, AB, Canada. 6. 6 St. George's Hospital, London, UK. 7. 7 University of Alberta, Edmonton, AB, Canada. 8. 8 Frimley Park Hospital, Frimley, Surrey, UK. 9. 9 Royal Surrey County Hospital, Guildford, Surrey, UK. 10. 10 Torbay Hospital, Torquay, Devon, UK. 11. 11 Department of Orthopaedics, University of British Columbia, Vancouver, BC, Canada. 12. 12 Department of Orthopaedics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. 13. 13 Division of Orthopaedic Surgery, St. Michael's Hospital, Toronto, ON, Canada.
Abstract
BACKGROUND: : A prospective, randomized, noninferiority clinical trial of synthetic cartilage implant hemiarthroplasty for hallux rigidus demonstrated functional outcomes and safety equivalent to first metatarsophalangeal (MTP) joint arthrodesis at 24 months. We prospectively assessed safety and efficacy outcomes for synthetic cartilage implant hemiarthroplasty at a minimum of 5 years. METHODS: : Of 135 eligible patients from the original trial, 112 (83.0%) were enrolled (mean age, 58.2 ± 8.8 years; 87 females). Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL), and FAAM Sports subscales were completed preoperatively and 2 and 5 years postoperatively. Great toe active dorsiflexion, weightbearing radiographs, secondary procedures, and safety parameters were also evaluated. RESULTS: : At 24 months, 14/152 (9.2%) patients had undergone implant removal and conversion to arthrodesis. In years 2 to 5, 9/119 (7.6%) patients underwent implant removal and conversion to arthrodesis. At mean 5.8 ± 0.7 (range, 4.4-8.0) years' follow-up, pain VAS, FAAM ADL, and FAAM Sports scores improved by 57.9 ± 18.6 points, 33.0 ± 17.6 points, and 47.9 ± 27.1 points, respectively, from baseline. Clinically significant changes in VAS pain, FAAM ADL, and FAAM Sports were reported by 103/106 (97.2%), 95/105 (90.5%), and 97/104 (93.3%) patients, respectively. Patient-reported outcomes at 24 months were maintained at 5.8 years in patients who were not revised. Active MTP joint peak dorsiflexion was maintained. Ninety-nine of 106 (93.4%) patients would have the procedure again. CONCLUSION: : Clinical and safety outcomes for synthetic cartilage implant hemiarthroplasty observed at 2 years were maintained at 5.8 years. The implant remains a viable treatment option to decrease pain, improve function, and maintain motion for advanced hallux rigidus. LEVEL OF EVIDENCE:: Level IV, case series.
RCT Entities:
BACKGROUND: : A prospective, randomized, noninferiority clinical trial of synthetic cartilage implant hemiarthroplasty for hallux rigidus demonstrated functional outcomes and safety equivalent to first metatarsophalangeal (MTP) joint arthrodesis at 24 months. We prospectively assessed safety and efficacy outcomes for synthetic cartilage implant hemiarthroplasty at a minimum of 5 years. METHODS: : Of 135 eligible patients from the original trial, 112 (83.0%) were enrolled (mean age, 58.2 ± 8.8 years; 87 females). Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL), and FAAM Sports subscales were completed preoperatively and 2 and 5 years postoperatively. Great toe active dorsiflexion, weightbearing radiographs, secondary procedures, and safety parameters were also evaluated. RESULTS: : At 24 months, 14/152 (9.2%) patients had undergone implant removal and conversion to arthrodesis. In years 2 to 5, 9/119 (7.6%) patients underwent implant removal and conversion to arthrodesis. At mean 5.8 ± 0.7 (range, 4.4-8.0) years' follow-up, pain VAS, FAAM ADL, and FAAM Sports scores improved by 57.9 ± 18.6 points, 33.0 ± 17.6 points, and 47.9 ± 27.1 points, respectively, from baseline. Clinically significant changes in VAS pain, FAAM ADL, and FAAM Sports were reported by 103/106 (97.2%), 95/105 (90.5%), and 97/104 (93.3%) patients, respectively. Patient-reported outcomes at 24 months were maintained at 5.8 years in patients who were not revised. Active MTP joint peak dorsiflexion was maintained. Ninety-nine of 106 (93.4%) patients would have the procedure again. CONCLUSION: : Clinical and safety outcomes for synthetic cartilage implant hemiarthroplasty observed at 2 years were maintained at 5.8 years. The implant remains a viable treatment option to decrease pain, improve function, and maintain motion for advanced hallux rigidus. LEVEL OF EVIDENCE:: Level IV, case series.
Entities:
Keywords:
clinical outcome; first metatarsophalangeal joint; function; hallux rigidus; hemiarthroplasty; osteoarthritis of the great toe; range of motion; synthetic cartilage implant
Authors: Stephanie K Eble; Oliver B Hansen; Bopha Chrea; Taylor N Cabe; Jonathan Garfinkel; Mark C Drakos Journal: Foot Ankle Int Date: 2020-07-10 Impact factor: 2.827