Tourniquet Use for Anterior Cruciate Ligament Repair

Overseen By Caleb Michalek, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OrthoCarolina Research Institute, Inc.

Must not be taking: Epinephrine, TXA

Disqualifiers: Concomitant procedures, Hemophilia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

34 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of tourniquet use in ACL reconstruction treatment?

Research shows that using a tourniquet during ACL reconstruction surgery can improve the surgeon's ability to see clearly during the operation, which may lead to similar recovery outcomes compared to not using a tourniquet. ^{1 2 3 4 5}

Is tourniquet use in ACL reconstruction surgery safe?

Tourniquet use in ACL reconstruction surgery is generally considered safe, but there is a small risk of infection, which can lead to complications. Studies show that using a tourniquet can improve the surgery process without significantly affecting recovery, though it may cause some temporary swelling and pain. ^{1 2 3 5 6}

What is the purpose of this 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.

Research Team

Jonathan Riboh, MD

Principal Investigator

OrthoCarolina Research Institute, Inc.

Eligibility Criteria

This trial is for English-speaking adults over 18 who need ACL reconstruction using their own patellar tendon and can attend specific physical therapy locations. It's not for those with additional knee surgeries, bleeding disorders, or allergies to certain medications used in the study.

Inclusion Criteria

English speaking

I am having ACL surgery with a graft from my patellar tendon.

Exclusion Criteria

Participation in physical therapy at any facility other than the OrthoCarolina Randolph, Matthews or South Park locations

I am not adhering to the specific study guidelines for anesthesia, medication, and post-surgery rehab.

I am only having minor knee surgeries along with my main procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo ACL reconstruction with or without limited tourniquet use

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for post-operative pain, limb symmetry index, and quadriceps function

6 months

Multiple visits (in-person) at 2 weeks, 6 weeks, 3 months, and 6 months

Follow-up

Participants are monitored for long-term outcomes such as limb symmetry index and quadriceps strength

up to 48 months

Treatment Details

Interventions

• ACL Reconstruction

Trial Overview The study tests if using a tourniquet during ACL surgery affects how well you can see inside the joint, surgery duration, patient pain levels intra-operatively and post-operatively, and speed of quadriceps muscle recovery.

Participant Groups

Group I: Control Active Control 1 Intervention

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

Group II: Treatment/Intervention Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials

37

Recruited

6,000+

Findings from Research

ACL reconstruction is a generally safe and effective procedure for knee stability, but infections, although rare, can lead to serious complications and poor outcomes.

Early diagnosis and treatment of infections with culture-specific antibiotics and debridement are crucial to prevent further damage to the knee, while the type of graft used does not appear to influence infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infections in anterior cruciate ligament reconstruction. Stucken, C., Garras, DN., Shaner, JL., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Tourniquet use in arthroscopic anterior cruciate ligament reconstruction: a systematic review and meta-analysis of randomised controlled trials. [2018]

2. Japan pubmed.ncbi.nlm.nih.gov

The effect of tourniquet use on operative performance and early postoperative results of anatomic double-bundle anterior cruciate ligament reconstruction. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Tourniquet Use Improves Intraoperative Parameters, Leading to Similar Postoperative Outcomes Compared With No Tourniquet Use in Anterior Cruciate Ligament Reconstruction: A Prospective, Double-Blind, Randomized Clinical Trial. [2023]

4. France pubmed.ncbi.nlm.nih.gov

Tourniquet used in anterior cruciate ligament reconstruction: a system review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament reconstruction without the use of a tourniquet. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Infections in anterior cruciate ligament reconstruction. [2022]