Cathrine Aga1,2,3,4, May Arna Risberg2,5, Morten Wang Fagerland3,6, Steinar Johansen7, Ingrid Trøan2, Stig Heir1,3, Lars Engebretsen2,3,4. 1. Department of Orthopedic Surgery, Martina Hansens Hospital, Bærum, Norway. 2. Department of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway. 3. Oslo Sports Trauma Research Center, Oslo, Norway. 4. Institute of Clinical Medicine, University of Oslo, Oslo, Norway. 5. Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway. 6. Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway. 7. Department of Orthopedic Surgery, Lovisenberg Diaconal Hospital, Oslo, Norway.
Abstract
BACKGROUND: The double-bundle reconstruction technique was developed to resemble the properties of the native anterior cruciate ligament (ACL) more closely than the conventional single-bundle technique. The clinical benefit of the operative procedure is controversial, and there is a need for studies with a focus on patient-reported outcomes (PROs). STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. HYPOTHESIS: Anatomic double-bundle ACL reconstruction would be superior to anatomic single-bundle reconstruction regarding the change in the Knee injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subscore from baseline to 2-year follow-up. METHODS: According to sample size calculations, 120 patients aged 18 to 40 years with a primary ACL injury of their knee were randomized to the anatomic double-bundle or anatomic single-bundle reconstruction groups. Patients with posterior cruciate ligament, posterolateral corner, or lateral collateral ligament injuries or with established osteoarthritis were excluded. Patients with residual laxity from a coexistent medial collateral ligament injury were excluded. Data were registered at baseline, 1 year, and 2 years. In 24 patients, postoperative 3-dimensional computed tomography was performed to verify the positioning of the bundles. The outcome measures were the change in KOOS subscores and the International Knee Documentation Committee 2000 subjective score, pivot-shift test result, Lachman test finding, KT-1000arthrometer measurement, activity level, return-to-sports rate, and osteoarthritic changes on radiographs. A linear mixed model was used for the analysis of all the PROs, including the primary outcome. RESULTS: The change in the KOOS QoL subscore from baseline to 2-year follow-up was not different between the double- and single-bundle groups (mean change, 29.2 points vs 28.7 points, respectively; -0.5-point difference; 95% CI, -8.4 to 7.4 points; P = .91). Neither were there any differences between the 2 groups in the remaining PROs, knee laxity measurements, or activity levels of the patients. Radiological signs of osteoarthritis were found in 2 patients. Eleven patients had a graft rupture: 8 in the single-bundle group and 3 in the double-bundle group ( P = .16). Three-dimensional computed tomography of the knees verified the positioning of the anteromedial bundle, posterolateral bundle, and single-bundle grafts to be within acceptable limits. CONCLUSION: There was no difference in the KOOS QoL subscore, the remaining PROs, knee laxity measurements, or activity levels comparing the double- and single-bundle ACL reconstruction techniques. The number of bundles does not seem to influence clinical and subjective outcomes, as long as the tunnels are adequately positioned. Registration: NCT01033188 ( ClinicalTrials.gov identifier).
RCT Entities:
BACKGROUND: The double-bundle reconstruction technique was developed to resemble the properties of the native anterior cruciate ligament (ACL) more closely than the conventional single-bundle technique. The clinical benefit of the operative procedure is controversial, and there is a need for studies with a focus on patient-reported outcomes (PROs). STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. HYPOTHESIS: Anatomic double-bundle ACL reconstruction would be superior to anatomic single-bundle reconstruction regarding the change in the Knee injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subscore from baseline to 2-year follow-up. METHODS: According to sample size calculations, 120 patients aged 18 to 40 years with a primary ACL injury of their knee were randomized to the anatomic double-bundle or anatomic single-bundle reconstruction groups. Patients with posterior cruciate ligament, posterolateral corner, or lateral collateral ligament injuries or with established osteoarthritis were excluded. Patients with residual laxity from a coexistent medial collateral ligament injury were excluded. Data were registered at baseline, 1 year, and 2 years. In 24 patients, postoperative 3-dimensional computed tomography was performed to verify the positioning of the bundles. The outcome measures were the change in KOOS subscores and the International Knee Documentation Committee 2000 subjective score, pivot-shift test result, Lachman test finding, KT-1000 arthrometer measurement, activity level, return-to-sports rate, and osteoarthritic changes on radiographs. A linear mixed model was used for the analysis of all the PROs, including the primary outcome. RESULTS: The change in the KOOS QoL subscore from baseline to 2-year follow-up was not different between the double- and single-bundle groups (mean change, 29.2 points vs 28.7 points, respectively; -0.5-point difference; 95% CI, -8.4 to 7.4 points; P = .91). Neither were there any differences between the 2 groups in the remaining PROs, knee laxity measurements, or activity levels of the patients. Radiological signs of osteoarthritis were found in 2 patients. Eleven patients had a graft rupture: 8 in the single-bundle group and 3 in the double-bundle group ( P = .16). Three-dimensional computed tomography of the knees verified the positioning of the anteromedial bundle, posterolateral bundle, and single-bundle grafts to be within acceptable limits. CONCLUSION: There was no difference in the KOOS QoL subscore, the remaining PROs, knee laxity measurements, or activity levels comparing the double- and single-bundle ACL reconstruction techniques. The number of bundles does not seem to influence clinical and subjective outcomes, as long as the tunnels are adequately positioned. Registration: NCT01033188 ( ClinicalTrials.gov identifier).
Authors: Mohammed S Alomari; Abdullah A Ghaddaf; Ahmed S Abdulhamid; Mohammed S Alshehri; Mujeeb Ashraf; Hatem H Alharbi Journal: Indian J Orthop Date: 2022-08-29 Impact factor: 1.033
Authors: Anderson de Aquino Santos; Mario Carneiro-Filho; Roberto Freire da Mota E Albuquerque; João Paulo Freire Martins de Moura; Carlos Eduardo Franciozi; Marcus Vinícius Malheiros Luzo Journal: Clinics (Sao Paulo) Date: 2020-04-30 Impact factor: 2.365
Authors: Jelle P van der List; Harmen D Vermeijden; Inger N Sierevelt; Maarten V Rademakers; Mark L M Falke; Gijs T T Helmerhorst; Roy A G Hoogeslag; Wybren A van der Wal; Arthur van Noort; Gino M M J Kerkhoffs Journal: BMC Musculoskelet Disord Date: 2021-04-30 Impact factor: 2.362