About this trial
The purpose of this study is to determine whether the addition of Lateral Extra-Articular Tenodesis (LET) influences postoperative lower-extremity LM recovery following bone-patellar tendon-bone (BTB) Anterior Cruciate Ligament Reconstruction (ACLR). We hypothesize that patients undergoing ACLR BTB with LET will demonstrate greater loss of operative-leg LM at 9 months postoperatively compared with patients undergoing isolated ACLR BTB.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Skeletally mature patients less than or equal to 60 years of age with ACL insufficiency scheduled to undergo primary BTB ACL reconstruction with or without LET.
Patients presenting with acute ACL injuries. Patients presenting with acute ACL injuries will be eligible for enrollment.
Acute injuries will be defined as injuries occurring within 6 weeks of presentation.
Disqualifiers
undergoing multi ligamentous reconstruction (PCL, MCL, or PLC)
revision ACL reconstruction
neuromuscular disorders
contralateral ACL injury
Trial design
Parallel
Treatments tested in this trial
Bone-patellar Tendon-bone (BTB)
Procedure/SurgeryHarvested with bone on both ends of soft tissue. A portion of the patient's patellar tendon, along with bone plugs from the patella and tibial tubercle, is harvested and used to reconstruct the torn ACL through bone tunnels created in the tibia and femur.
Bone-patellar Tendon-bone (BTB) and Lateral Extra-Articular Tenodesis (LET)
Procedure/SurgeryA strip of the iliotibial band on the outside of the knee is used to provide additional stability and reduce abnormal rotational movement following ACL reconstruction.
Treatment groups
Trial outcomes
Primary outcomes
Change in operative-leg lean mass (LM)
Sponsors and contacts
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