Paul Marks1, Siobhan O'Donnell, Gilbert Yee. 1. Department of Orthopaedic Surgery, Holland Orthopaedic & Arthritic Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. paul.marks@sunnybrook.ca
Abstract
PURPOSE: To compare the clinical efficacy of ACL reconstruction using the Mitek bone-tendon-bone cross pin (RIGIDfix) to the Linvatec Bioscrew (control device). METHODS:Forty subjects were randomized into one of two groups: the RIGIDfix or control group. Eligible subjects were male and female, 18 years of age and older, with an ACL injury of at least 3 weeks duration and no evidence of ACL insufficiency on the contralateral side. Subjects were followed for 24-month post-operatively. Evaluations included the International Knee Documentation Committee (IKDC) Knee Ligament Standard Evaluation, Mohtadi's ACL Deficiency Quality of Life (ACL-QOL) questionnaire and the attainment of six rehabilitation milestones. Subjects and assessors were blinded to the surgical device used. RESULTS: Four subjects in the RIGIDfix group and four controls were lost to follow-up. The change in final IKDC scores did not differ significantly between groups with the majority demonstrating an improvement of one to two grades. The change in ACL-QOL scores did not differ significantly between the RIGIDfix subjects (40.0+4.4) and controls (46.0+3.6). Furthermore, the number of weeks that the RIGIDfix subjects versus controls attained full active extension, functional range of motion, normal gait, stair climbing, running gait and sprinting did not differ significantly. CONCLUSIONS: The RIGIDfix results in a similar post-operative course to the control device and is efficacious for the reconstruction of the ACL. No adverse events were associated with the use of the RIGIDfix. The results of this study should be considered preliminary due to the small sample size.
RCT Entities:
PURPOSE: To compare the clinical efficacy of ACL reconstruction using the Mitek bone-tendon-bone cross pin (RIGIDfix) to the Linvatec Bioscrew (control device). METHODS: Forty subjects were randomized into one of two groups: the RIGIDfix or control group. Eligible subjects were male and female, 18 years of age and older, with an ACL injury of at least 3 weeks duration and no evidence of ACL insufficiency on the contralateral side. Subjects were followed for 24-month post-operatively. Evaluations included the International Knee Documentation Committee (IKDC) Knee Ligament Standard Evaluation, Mohtadi's ACL Deficiency Quality of Life (ACL-QOL) questionnaire and the attainment of six rehabilitation milestones. Subjects and assessors were blinded to the surgical device used. RESULTS: Four subjects in the RIGIDfix group and four controls were lost to follow-up. The change in final IKDC scores did not differ significantly between groups with the majority demonstrating an improvement of one to two grades. The change in ACL-QOL scores did not differ significantly between the RIGIDfix subjects (40.0+4.4) and controls (46.0+3.6). Furthermore, the number of weeks that the RIGIDfix subjects versus controls attained full active extension, functional range of motion, normal gait, stair climbing, running gait and sprinting did not differ significantly. CONCLUSIONS: The RIGIDfix results in a similar post-operative course to the control device and is efficacious for the reconstruction of the ACL. No adverse events were associated with the use of the RIGIDfix. The results of this study should be considered preliminary due to the small sample size.
Authors: Jeff R S Leiter; Nevin de Korompay; Lindsey Macdonald; Sheila McRae; Warren Froese; Peter B Macdonald Journal: Knee Surg Sports Traumatol Arthrosc Date: 2011-02-03 Impact factor: 4.342
Authors: Stephan Frosch; Anne Rittstieg; Peter Balcarek; Tim Alexander Walde; Jan P Schüttrumpf; Martin M Wachowski; Klaus M Stürmer; Karl-Heinz Frosch Journal: Knee Surg Sports Traumatol Arthrosc Date: 2012-11 Impact factor: 4.342