Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT02918734
Brief Summary:
In this randomized controlled trial the investigators will compare the results after primary anterior cruciate ligament (ACL) reconstruction using two different methods for femoral fixation of a bone-patellar tendon-bone (BPTB) autograft. Interference screws have been the standard method for fixing the femoral side of BPTB grafts; however, several pitfalls have been reported. Cortical fixation with the Endobutton CL BTB Fixation System has become available and the clinical results have been described as promising; however, no randomized controlled trials comparing these two femoral fixation methods have been conducted, and there is no published data that confirms that the bone block heals in the tunnel with the newer method.
The aim of our study is to compare the outcome after primary ACL reconstruction with BPTB autografts using the Endobutton CL BTB or metal interference screw for femoral fixation.
Detailed Description:
Primary anterior cruciate ligament (ACL) reconstructions with bone-patellar tendon-bone (BPTB) autografts have recently been found to have a lower risk of revision compared with hamstring tendon autografts, and BPTB has again become our graft of choice. Interference screws have been the standard method for fixing the femoral side of a BPTB graft; however problems such as damage of the graft and failure due to nonparallel screw placement have been reported. Cortical fixation using a suspensory system has been used for soft-tissue graft fixation for several years, and a corresponding device, the Endobutton CL BTB Fixation System (Smith \& Nephew, Inc., Andover, MA, USA), has become available for fixation of bone-tendon-bone grafts. The clinical results after fixation with the Endobutton CL BTB have been described as promising; however, no randomized controlled trials comparing these two fixation methods have been conducted, and there is no published data that confirms that the bone block heals in the tunnel with the newer method.
In this randomized controlled trial, patients undergoing primary ACL reconstruction will be randomized into either an Endobutton group or an interference screw group. The primary aim of the study is to compare these two fixation methods, assessed by patient reported outcomes, laxity, range of motion and muscle strength. Knee related quality of life 2 years after surgery is the primary outcome, measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) subscale "knee related Quality of life (QOL)". Other aims are to see if there is any difference in the integration of the bone block in the femoral tunnel assessed by CT scan, in the risk of developing osteoarthritis assessed by radiographs, or in the risk of a postoperative complication or revision. The patients will be followed up 6 weeks, 6 months, 2 years and 10 years after surgery. CT scan will be performed after 6 months, and radiographs after 2 years and 10 years. In addition details of the rehabilitation will be recorded. Patients undergoing a revision will be followed up but excluded from further comparisons in the study.
Our hypothesis is that there is no difference in the outcome after primary ACL reconstruction with BPTB autografts using the Endobutton CL BTB or metal interference screw for femoral fixation, both with a metal interference screw for the tibial fixation.
Study:
NCT02918734
Study Brief:
Protocol Section:
NCT02918734