Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05931627
Other study ID # SPORT177
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 8, 2024
Est. completion date December 31, 2026

Study information

Verified date April 2024
Source OrthoCarolina Research Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 34
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • ACL - Anterior Cruciate Ligament Deficiency
  • ACL Injury
  • ACL Tear
  • Anterior Cruciate Ligament Injuries

Intervention

Procedure:
Patients undergoing ACL reconstruction with or without a tourniquet
Patients undergoing ACL reconstruction with or without a tourniquet

Locations

Country Name City State
United States OrthoCarolina Research Institute, Inc. Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
OrthoCarolina Research Institute, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Sex Sex preoperative
Other Race Race preoperative
Other Ethnicity Ethnicity preoperative
Other Body Mass Index (BMI) Body Mass Index (BMI) preoperative
Primary Limb symmetry index (LSI) Limb symmetry index (LSI) of the peak torque of the quadriceps 6 months
Secondary Arthroscopic visibility Arthroscopic visibility during surgery
Secondary Operative time Operative time during surgery
Secondary Intra-operative opioid requirements Intra-operative opioid requirements (in morphine milligram equivalents (MMEs) during surgery
Secondary PACU opioid requirements PACU opioid requirements (MMEs) during surgery
Secondary Post-operative pain in PACU Post-operative pain in PACU measured by a Numeric Rating Scale during surgery
Secondary LSI of peak strength and rate of torque development of the quadriceps 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 6 weeks
Secondary LSI of peak strength and rate of torque development of the quadriceps 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 6 months
Secondary Quadriceps circumference 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. preoperative, 2 weeks, 6 weeks, 3 months and 6 months
Secondary Number of days post-operatively until the patient can complete a straight leg raise with no extensor lag at physical therapy. 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
Secondary Number of days post-operatively until the patient can actively hyper-extend their knee at physical therapy. 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
Secondary IKDC and the Marx Activity Rating Scale scores subjective knee evaluation 6 weeks
Secondary IKDC and the Marx Activity Rating Scale scores subjective knee evaluation 1 year
Secondary Limb symmetry index (LSI) Limb symmetry index (LSI) of the peak torque of the quadriceps 6 weeks
Secondary Limb symmetry index (LSI) Limb symmetry index (LSI) of the peak torque of the quadriceps 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT04519801 - BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft N/A
Withdrawn NCT03389685 - Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury Phase 2
Recruiting NCT04958733 - Does Bone Grafting at the Time of Bone-Patellar Tendon-Bone ACL Reconstruction Reduce the Incidence of Post-operative Anterior Knee Pain: A Randomized Controlled Clinical Study N/A
Terminated NCT04101682 - Continuous Vs Single Shot Block After ACL Early Phase 1
Not yet recruiting NCT05374382 - A Prehab Strengthening Program Prior to ACL Surgery on Lower Limb Structure and Function N/A
Not yet recruiting NCT04068701 - Real-time Sensorimotor Feedback for Injury Prevention in Males Assessed in Virtual Reality N/A
Recruiting NCT03479775 - Muscle Function and Traumatic Knee Injury in Sports
Not yet recruiting NCT05498285 - Post-ACL Reconstruction Rehab UPSCALER App RCT HPUPM N/A
Recruiting NCT05461625 - ACL Reconstruction With/Without ALL Reconstruction N/A
Active, not recruiting NCT03491046 - Molecular Imaging Assessment of ACL Viability N/A
Withdrawn NCT04342000 - The Effect of Movement Education on Jumping/Landing Quality in High School Athletes N/A
Completed NCT04993339 - Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound Phase 3
Withdrawn NCT03614351 - Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery N/A
Withdrawn NCT03670550 - Dynamic ACL Brace: In Vivo Kinematics N/A
Recruiting NCT06206200 - The Effect of Cognitive Dual-task Rehabilitation on Arthrogenic Muscle Responses After ACL Reconstruction N/A
Recruiting NCT06430775 - Exploring Prolonged AMR in ACL Reconstructed Patients
Active, not recruiting NCT06167343 - Comparison of Semitendinosus and Quadriceps Grafts for Anterior Cruciate Ligament Reconstruction N/A
Completed NCT04541940 - TeleRehabilitation Following ACL Reconstruction N/A
Terminated NCT03497780 - Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction:
Completed NCT04967937 - Neuromuscular Training Improves Single-Limb Stability N/A