BACKGROUND: Biodegradable cross-pins have been shown to provide higher failure loads than do screws for fixation of hamstring tendons under laboratory conditions. PURPOSE: To compare the clinical results of biodegradable pins (RigidFix) and interference screws (BioCryl) for fixation of hamstring grafts in arthroscopically assisted anterior cruciate ligament reconstruction. Study Design Randomized controlled trial; Level of evidence, 1. METHODS: To test the hypothesis of a difference of 1.0 +/- 1.2 mm in anterior knee laxity between the two fixation options, 54 patients were randomly assigned to groups via a block randomization scheme and sealed envelopes. All patients underwent standardized hamstring graft reconstruction and had similar postoperative aftercare by an accelerated rehabilitation protocol. Measures assessed at baseline and after 1 and 2 years of follow-up included (1) the side-to-side difference in anterior laxity (KT-1000 arthrometer), (2) Short Form 36 physical and mental component scores, and (3) the International Knee Documentation Committee form scores. RESULTS: After 1 and 2 years, 26 and 21 patients in the BioCryl group and 28 and 24 patients in the RigidFix group were available for follow-up examination. No significant difference was noted in instrumented anterior translation between BioCryl and RigidFix fixation: 1 year, 0.11 (95% CI, -0.60 to 0.82; P = .7537); 2 years, 0.33 (95% CI, -0.43 to 1.08 mm; P = .3849). Also, there were no significant differences in the mean physical and mental component scores and International Knee Documentation Committee form scores and in overall complication and surgical revision rates. A pin dislocation was classified as the sole procedure-specific serious adverse event. CONCLUSION: Bioresorbable pins do not provide better clinical results than do resorbable interference screws for hamstring graft fixation in anterior cruciate ligament reconstruction surgery.
RCT Entities:
BACKGROUND: Biodegradable cross-pins have been shown to provide higher failure loads than do screws for fixation of hamstring tendons under laboratory conditions. PURPOSE: To compare the clinical results of biodegradable pins (RigidFix) and interference screws (BioCryl) for fixation of hamstring grafts in arthroscopically assisted anterior cruciate ligament reconstruction. Study Design Randomized controlled trial; Level of evidence, 1. METHODS: To test the hypothesis of a difference of 1.0 +/- 1.2 mm in anterior knee laxity between the two fixation options, 54 patients were randomly assigned to groups via a block randomization scheme and sealed envelopes. All patients underwent standardized hamstring graft reconstruction and had similar postoperative aftercare by an accelerated rehabilitation protocol. Measures assessed at baseline and after 1 and 2 years of follow-up included (1) the side-to-side difference in anterior laxity (KT-1000 arthrometer), (2) Short Form 36 physical and mental component scores, and (3) the International Knee Documentation Committee form scores. RESULTS: After 1 and 2 years, 26 and 21 patients in the BioCryl group and 28 and 24 patients in the RigidFix group were available for follow-up examination. No significant difference was noted in instrumented anterior translation between BioCryl and RigidFix fixation: 1 year, 0.11 (95% CI, -0.60 to 0.82; P = .7537); 2 years, 0.33 (95% CI, -0.43 to 1.08 mm; P = .3849). Also, there were no significant differences in the mean physical and mental component scores and International Knee Documentation Committee form scores and in overall complication and surgical revision rates. A pin dislocation was classified as the sole procedure-specific serious adverse event. CONCLUSION: Bioresorbable pins do not provide better clinical results than do resorbable interference screws for hamstring graft fixation in anterior cruciate ligament reconstruction surgery.
Authors: Luiz Gabriel Betoni Guglielmetti; Ricardo de Paula Leite Cury; Victor Marques de Oliveira; Osmar Pedro Arbix de Camargo; Nilson Roberto Severino; Patrícia Maria de Moraes Barros Fucs Journal: J Orthop Surg Res Date: 2014-11-19 Impact factor: 2.359