Clinical trial NCT05931627: Tourniquet Use in Anterior Cruciate Ligament Repair
Official title: The Implications of Tourniquet Use on Early Quadriceps Function in Anterior Cruciate Ligament Reconstructions: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: ACL - Anterior Cruciate Ligament Deficiency
ACL Injury
ACL Tear
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded randomized controlled clinical trial
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Limb symmetry index (LSI)
timeFrame: 6 months
Secondary outcomes:
measure: Arthroscopic visibility
timeFrame: during surgery
measure: Operative time
timeFrame: during surgery
measure: Intra-operative opioid requirements
timeFrame: during surgery
measure: PACU opioid requirements
timeFrame: during surgery
measure: Post-operative pain in PACU
timeFrame: during surgery
measure: LSI of peak strength and rate of torque development of the quadriceps
timeFrame: 6 weeks
measure: LSI of peak strength and rate of torque development of the quadriceps
timeFrame: 6 months
measure: Quadriceps circumference
timeFrame: preoperative, 2 weeks, 6 weeks, 3 months and 6 months
measure: Number of days post-operatively until the patient can complete a straight leg raise with no extensor lag at physical therapy.
timeFrame: 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
measure: Number of days post-operatively until the patient can actively hyper-extend their knee at physical therapy.
timeFrame: 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
measure: IKDC and the Marx Activity Rating Scale scores
timeFrame: 6 weeks
measure: IKDC and the Marx Activity Rating Scale scores
timeFrame: 1 year
measure: Limb symmetry index (LSI)
timeFrame: 6 weeks
measure: Limb symmetry index (LSI)
timeFrame: 3 months
Other outcomes:
measure: Sex
timeFrame: preoperative
measure: Race
timeFrame: preoperative
measure: Ethnicity
timeFrame: preoperative
measure: Body Mass Index (BMI)
timeFrame: preoperative
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute, Inc.
state: North Carolina
Study officials:
affiliation: OrthoCarolina Research Institute, Inc.
name: Jonathan Riboh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
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citation: 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.
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