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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using a tourniquet for a shorter duration during ACL (anterior cruciate ligament) reconstruction affects surgery outcomes. Researchers believe that limited tourniquet use might reduce pain during and after surgery and help patients regain muscle function faster. Participants will undergo surgery with either continuous tourniquet use or brief use during a specific part of the procedure. Ideal candidates are adults needing ACL reconstruction using a specific knee graft method and who speak English. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance surgical recovery for future patients.

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 prior data suggests that tourniquet use during ACL reconstruction is safe?

Studies have shown that using a tourniquet during ACL (anterior cruciate ligament) surgery can increase pain and fluid drainage post-operation. However, it does not have long-term negative effects on thigh muscle strength. Research indicates that while a tourniquet doesn't cause lasting harm, it may make short-term recovery more uncomfortable. In this trial, one group will use the tourniquet for a shorter duration, potentially resulting in less pain and a quicker recovery for those patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different uses of a tourniquet can impact the recovery process for ACL reconstruction. The standard approach often involves using a tourniquet throughout the entire surgery, but this trial tests using it only during the initial graft harvest for a short period. This could potentially reduce complications like muscle damage and improve overall recovery. By investigating these methods, researchers hope to find a way to make ACL surgery safer and enhance patient outcomes.

What evidence suggests that limited tourniquet use during ACL reconstruction could be effective?

This trial will compare two approaches to tourniquet use during ACL reconstruction. Research has shown that using a tourniquet during ACL surgery can increase pain and fluid drainage post-operation. Studies have found that a tourniquet does not improve visibility for the surgeon or speed up the procedure. Although tourniquets can cause more pain and temporary muscle weakness immediately after surgery, these effects are short-lived. Some evidence suggests that patients might regain leg muscle strength faster with shorter tourniquet use. Overall, reducing tourniquet use might lead to less pain and quicker muscle recovery after surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Jonathan Riboh, MD

Principal Investigator

OrthoCarolina Research Institute, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/10225536241293538

Use of tourniquet in anterior cruciate ligament reconstruction

Tourniquet use during ACL reconstruction does not improve intraoperative visualization and does not reduce surgical time but leads to greater postoperative ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11619283/

Arthroscopic anterior cruciate ligament reconstruction with and ...

Our meta-analysis indicates that tourniquet use during arthroscopic ACL reconstruction is associated with higher pain levels, increased postoperative drain ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666061X24001834

Tourniquet Use During Anterior Cruciate Ligament ...

Tourniquet use during ACL reconstruction does not have negative long-term effects on quadriceps strength. Although tourniquet use was associated with increased ...

4.

isakos.com

isakos.com/GlobalLink/Abstract/7861

Effect Of Tourniquet Use During ACL Reconstruction

Tourniquet use was associated with increased quadriceps atrophy and pain in the immediate post-operative period, but such effects do not persist chronically.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39639263/

Arthroscopic anterior cruciate ligament reconstruction with ...

Our meta-analysis indicates that tourniquet use during arthroscopic ACL reconstruction is associated with higher pain levels, increased postoperative drain ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06819696

Tourniquet vs. Dual-flow Arthroscopy Sheath in Anterior ...

This study propose to compare two groups of patients undergoing ACL reconstruction: those operated on with a tourniquet versus those operated on using the dual- ...