NCT05931627

Tourniquet Use in Anterior Cruciate Ligament Repair

The Implications of Tourniquet Use on Early Quadriceps Function in Anterior Cruciate Ligament Reconstructions: A Randomized Controlled Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: OrthoCarolina Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the intra-operative and post-operative effects of tourniquet use during ACL reconstruction. We hypothesize that: 1. Limited tourniquet use will not significantly impact arthroscopic visualization nor the time it takes to complete an ACL reconstruction. 2. Limited tourniquet use will lead to significantly less patient pain intra-operatively and in the immediate peri-operative period. 3. Patients who undergo an ACL reconstruction with limited tourniquet use will have earlier return of quadriceps functions as compared to those undergoing reconstruction with the use of a tourniquet.

Detailed description

Type of Study Double-blinded randomized controlled clinical trial Group 1 (Control): Patients undergoing patellar bone-tendon-bone autograft ACL reconstruction with a tourniquet used for the duration of the case. Group 2 (Treatment/Intervention, if applicable): Patients undergoing ACL reconstruction with a tourniquet used only during patellar bone-tendon-bone autograft harvest, for a maximum of 20 minutes.

Conditions

• ACL - Anterior Cruciate Ligament Deficiency
• ACL Injury
• ACL Tear

Interventions

Type	Name	Description
PROCEDURE	Patients undergoing ACL reconstruction with or without a tourniquet	Patients undergoing ACL reconstruction with or without a tourniquet

Timeline

• Start date: 2024-03-08
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2023-07-05
• Last updated: 2025-04-30

Locations

1 site across 1 country: United States