Tourniquet Use in Anterior Cruciate Ligament Repair

ACL Injury Clinical Trial

Official title:

The Implications of Tourniquet Use on Early Quadriceps Function in Anterior Cruciate Ligament Reconstructions: A Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05931627
• Other study ID #: SPORT177
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

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 all — Click 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