Tourniquet Use in Anterior Cruciate Ligament Repair

OrthoCarolina Research Institute, Inc.

Status: Invitation-only

Conditions: ACL Tear; ACL - Anterior Cruciate Ligament Deficiency; ACL Injury

Treatments: Procedure: Patients undergoing ACL reconstruction with or without a tourniquet

Study type: Interventional

Funder types: Other

Identifiers

NCT05931627

SPORT177

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients undergoing an arthroscopic assisted ACLR using a bone-tendon-bone patellar tendon autograft.
2. 18 years or older
3. English speaking

Exclusion criteria

1. Concomitant procedures (e.g., osteotomy or other ligamentous reconstructions) other than chondroplasty, partial meniscectomy or meniscal repair
2. Medical contraindications to epinephrine or TXA use.
3. Hemophilia or other predisposition for bleeding
4. Does not follow study protocol in regard to regional anesthesia, TXA, epinephrine use in the arthroscopy fluid and post-operative rehabilitation.
5. Participation in physical therapy at any facility other than the OrthoCarolina Randolph, Matthews or South Park locations

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Control

No Intervention group

Description:

Patients undergoing patellar bone-tendon-bone autograft ACL reconstruction with a tourniquet used for the duration of the case.

Treatment/Intervention

Active Comparator group

Description:

Patients undergoing ACL reconstruction with a tourniquet used only during patellar bone-tendon-bone autograft harvest, for a maximum of 20 minutes.

Treatment:

Procedure: Patients undergoing ACL reconstruction with or without a tourniquet