Tourniquet Use in Anterior Cruciate Ligament Repair

Not Applicable

• Conditions: ACL Tear; ACL - Anterior Cruciate Ligament Deficiency; ACL Injury
• Interventions: Procedure: Patients undergoing ACL reconstruction with or without a tourniquet

• Registration Number: NCT05931627
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-05
• Study Start: 2024-03-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment/Intervention	Patients undergoing ACL reconstruction with or without a tourniquet	Patients undergoing ACL reconstruction with a tourniquet used only during patellar bone-tendon-bone autograft harvest, for a maximum of 20 minutes.

Primary Outcome Measures

Name	Time	Method
Limb symmetry index (LSI)	6 months	Limb symmetry index (LSI) of the peak torque of the quadriceps

Secondary Outcome Measures

Name	Time	Method
Limb symmetry index (LSI)	3 months	Limb symmetry index (LSI) of the peak torque of the quadriceps
Arthroscopic visibility	during surgery	Arthroscopic visibility
Operative time	during surgery	Operative time
Post-operative pain in PACU	during surgery	Post-operative pain in PACU measured by a Numeric Rating Scale
IKDC and the Marx Activity Rating Scale scores	1 year	subjective knee evaluation
Intra-operative opioid requirements	during surgery	Intra-operative opioid requirements (in morphine milligram equivalents (MMEs)
Quadriceps circumference	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.
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 complete a straight leg raise with no extensor lag at physical therapy.
PACU opioid requirements	during surgery	PACU opioid requirements (MMEs)
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	Number of days post-operatively until the patient can actively hyper-extend their knee at physical therapy.
LSI of peak strength and rate of torque development of the quadriceps	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

Trial Locations

Locations (1)

OrthoCarolina Research Institute, Inc.; 🇺🇸 Charlotte, North Carolina, United States