Tourniquet Use in Anterior Cruciate Ligament Repair

NCT05931627 | Enrolling By Invitation DMC

• 1 other identifier: SPORT177
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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. 1.Limited tourniquet use will not significantly impact arthroscopic visualization nor the time it takes to complete an ACL reconstruction.
2. 2.Limited tourniquet use will lead to significantly less patient pain intra-operatively and in the immediate peri-operative period.
3. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Limb symmetry index (LSI)

  Limb symmetry index (LSI) of the peak torque of the quadriceps

  6 months

Secondary Outcomes (14)

• Arthroscopic visibility

  during surgery

• Operative time

  during surgery

• Intra-operative opioid requirements

  during surgery

• PACU opioid requirements

  during surgery

• Post-operative pain in PACU

  during surgery

Other Outcomes (4)

• Sex

  preoperative

• Race

  preoperative

• Ethnicity

  preoperative

Study Arms (2)

Control

NO INTERVENTION

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

Treatment/Intervention

ACTIVE COMPARATOR

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

Interventions

Patients undergoing ACL reconstruction with or without a tourniquet PROCEDURE

Patients undergoing ACL reconstruction with or without a tourniquet

Treatment/Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing an arthroscopic assisted ACLR using a bone-tendon-bone patellar tendon autograft.
• years or older
• English speaking

You may not qualify if:

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

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, 28207, United States

Location

Related Publications (12)

• Grassi A, Carulli C, Innocenti M, Mosca M, Zaffagnini S, Bait C; SIGASCOT Arthroscopy Committee. New Trends in Anterior Cruciate Ligament Reconstruction: A Systematic Review of National Surveys of the Last 5 Years. Joints. 2018 Sep 27;6(3):177-187. doi: 10.1055/s-0038-1672157. eCollection 2018 Sep.

  PMID: 30582107 BACKGROUND

• Hooper J, Rosaeg OP, Krepski B, Johnson DH. Tourniquet inflation during arthroscopic knee ligament surgery does not increase postoperative pain. Can J Anaesth. 1999 Oct;46(10):925-9. doi: 10.1007/BF03013125.

  PMID: 10522577 BACKGROUND

• Reda W, ElGuindy AMF, Zahry G, Faggal MS, Karim MA. Anterior cruciate ligament reconstruction; is a tourniquet necessary? A randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2016 Sep;24(9):2948-2952. doi: 10.1007/s00167-015-3582-z. Epub 2015 Mar 19.

  PMID: 25786826 BACKGROUND

• Kuo LT, Yu PA, Chen CL, Hsu WH, Chi CC. Tourniquet use in arthroscopic anterior cruciate ligament reconstruction: a systematic review and meta-analysis of randomised controlled trials. BMC Musculoskelet Disord. 2017 Aug 22;18(1):358. doi: 10.1186/s12891-017-1722-y.

  PMID: 28830402 BACKGROUND

• Struijk-Mulder MC, Ettema HB, Verheyen CC, Buller HR. Deep vein thrombosis after arthroscopic anterior cruciate ligament reconstruction: a prospective cohort study of 100 patients. Arthroscopy. 2013 Jul;29(7):1211-6. doi: 10.1016/j.arthro.2013.04.015.

  PMID: 23809456 BACKGROUND

• Janssen RP, Reijman M, Janssen DM, van Mourik JB. Arterial complications, venous thromboembolism and deep venous thrombosis prophylaxis after anterior cruciate ligament reconstruction: A systematic review. World J Orthop. 2016 Sep 18;7(9):604-17. doi: 10.5312/wjo.v7.i9.604. eCollection 2016 Sep 18.

  PMID: 27672574 BACKGROUND

• Mingo-Robinet J, Castaneda-Cabrero C, Alvarez V, Leon Alonso-Cortes JM, Monge-Casares E. Tourniquet-related iatrogenic femoral nerve palsy after knee surgery: case report and review of the literature. Case Rep Orthop. 2013;2013:368290. doi: 10.1155/2013/368290. Epub 2013 Nov 26.

  PMID: 24371536 BACKGROUND

• Lee YG, Park W, Kim SH, Yun SP, Jeong H, Kim HJ, Yang DH. A case of rhabdomyolysis associated with use of a pneumatic tourniquet during arthroscopic knee surgery. Korean J Intern Med. 2010 Mar;25(1):105-9. doi: 10.3904/kjim.2010.25.1.105. Epub 2010 Feb 26.

  PMID: 20195412 BACKGROUND

• Nicholas SJ, Tyler TF, McHugh MP, Gleim GW. The effect on leg strength of tourniquet use during anterior cruciate ligament reconstruction: A prospective randomized study. Arthroscopy. 2001 Jul;17(6):603-7. doi: 10.1053/jars.2001.24854.

  PMID: 11447547 BACKGROUND

• Arciero RA, Scoville CR, Hayda RA, Snyder RJ. The effect of tourniquet use in anterior cruciate ligament reconstruction. A prospective, randomized study. Am J Sports Med. 1996 Nov-Dec;24(6):758-64. doi: 10.1177/036354659602400610.

  PMID: 8947397 BACKGROUND

• Merry K, Napier C, Chung V, Hannigan BC, MacPherson M, Menon C, Scott A. The Validity and Reliability of Two Commercially Available Load Sensors for Clinical Strength Assessment. Sensors (Basel). 2021 Dec 16;21(24):8399. doi: 10.3390/s21248399.

  PMID: 34960492 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Jonathan Riboh, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Treating physicians and subjects will be blinded to treatment group.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded randomized controlled clinical trial

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: July 5, 2023
• Study Start: March 8, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)