Tourniquet Use in Anterior Cruciate Ligament Repair

May 19, 2026 updated by: OrthoCarolina Research Institute, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Research Institute, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients undergoing patellar bone-tendon-bone autograft ACL reconstruction with a tourniquet used for the duration of the case.
Active Comparator: Treatment/Intervention
Patients undergoing ACL reconstruction with a tourniquet used only during patellar bone-tendon-bone autograft harvest, for a maximum of 20 minutes.
Procedure: Patients undergoing ACL reconstruction with or without a tourniquet
Patients undergoing ACL reconstruction with or without a tourniquet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limb symmetry index (LSI)
Time Frame: 6 months
Limb symmetry index (LSI) of the peak torque of the quadriceps
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arthroscopic visibility
Time Frame: during surgery
Arthroscopic visibility
during surgery
Operative time
Time Frame: during surgery
Operative time
during surgery
Intra-operative opioid requirements
Time Frame: during surgery
Intra-operative opioid requirements (in morphine milligram equivalents (MMEs)
during surgery
PACU opioid requirements
Time Frame: during surgery
PACU opioid requirements (MMEs)
during surgery
Post-operative pain in PACU
Time Frame: during surgery
Post-operative pain in PACU measured by a Numeric Rating Scale
during surgery
LSI of peak strength and rate of torque development of the quadriceps
Time Frame: 6 weeks
LSI of peak strength and rate of torque development of the quadriceps at 6 weeks, 3 months and 6 months as measured using a Tindeq Progressor 3000 dynamometer
6 weeks
LSI of peak strength and rate of torque development of the quadriceps
Time Frame: 6 months
LSI of peak strength and rate of torque development of the quadriceps at 6 weeks, 3 months and 6 months as measured using a Tindeq Progressor 3000 dynamometer
6 months
Quadriceps circumference
Time Frame: preoperative, 2 weeks, 6 weeks, 3 months and 6 months
Quadriceps circumference (at the proximal pole of the patella with the knee in extension) at 2 weeks, 6 weeks, 3 months and 6 months post-operatively, as compared to pre-operatively.
preoperative, 2 weeks, 6 weeks, 3 months and 6 months
Number of days post-operatively until the patient can complete a straight leg raise with no extensor lag at physical therapy.
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Number of days post-operatively until the patient can complete a straight leg raise with no extensor lag at physical therapy.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Number of days post-operatively until the patient can actively hyper-extend their knee at physical therapy.
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Number of days post-operatively until the patient can actively hyper-extend their knee at physical therapy.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
IKDC and the Marx Activity Rating Scale scores
Time Frame: 6 weeks
subjective knee evaluation
6 weeks
IKDC and the Marx Activity Rating Scale scores
Time Frame: 1 year
subjective knee evaluation
1 year
Limb symmetry index (LSI)
Time Frame: 6 weeks
Limb symmetry index (LSI) of the peak torque of the quadriceps
6 weeks
Limb symmetry index (LSI)
Time Frame: 3 months
Limb symmetry index (LSI) of the peak torque of the quadriceps
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sex
Time Frame: preoperative
Sex
preoperative
Race
Time Frame: preoperative
Race
preoperative
Ethnicity
Time Frame: preoperative
Ethnicity
preoperative
Body Mass Index (BMI)
Time Frame: preoperative
Body Mass Index (BMI)
preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OrthoCarolina Research Institute, Inc.

Investigators

  • Principal Investigator: Jonathan Riboh, MD, OrthoCarolina Research Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2024

Primary Completion (Actual)

February 19, 2026

Study Completion (Actual)

February 19, 2026

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPORT177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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