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Tourniquet Use in Anterior Cruciate Ligament Repair

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patients undergoing ACL reconstruction with or without a tourniquet
Sponsored by
OrthoCarolina Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for ACL - Anterior Cruciate Ligament Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients undergoing an arthroscopic assisted ACLR using a bone-tendon-bone patellar tendon autograft. 18 years or older English speaking Exclusion Criteria: 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

Sites / Locations

  • OrthoCarolina Research Institute, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Treatment/Intervention

Arm Description

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

Patients undergoing ACL reconstruction with a tourniquet used only during patellar bone-tendon-bone autograft harvest, for a maximum of 20 minutes.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Arthroscopic visibility
Arthroscopic visibility
Operative time
Operative time
Intra-operative opioid requirements
Intra-operative opioid requirements (in morphine milligram equivalents (MMEs)
PACU opioid requirements
PACU opioid requirements (MMEs)
Post-operative pain in PACU
Post-operative pain in PACU measured by a Numeric Rating Scale
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
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
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.
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.
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.
IKDC and the Marx Activity Rating Scale scores
subjective knee evaluation
IKDC and the Marx Activity Rating Scale scores
subjective knee evaluation
Limb symmetry index (LSI)
Limb symmetry index (LSI) of the peak torque of the quadriceps
Limb symmetry index (LSI)
Limb symmetry index (LSI) of the peak torque of the quadriceps

Full Information

First Posted
May 31, 2023
Last Updated
June 27, 2023
Sponsor
OrthoCarolina Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05931627
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrthoCarolina Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL - Anterior Cruciate Ligament Deficiency, ACL Injury, ACL Tear

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blinded randomized controlled clinical trial
Masking
ParticipantInvestigator
Masking Description
Treating physicians and subjects will be blinded to treatment group.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients undergoing patellar bone-tendon-bone autograft ACL reconstruction with a tourniquet used for the duration of the case.
Arm Title
Treatment/Intervention
Arm Type
Active Comparator
Arm Description
Patients undergoing ACL reconstruction with a tourniquet used only during patellar bone-tendon-bone autograft harvest, for a maximum of 20 minutes.
Intervention Type
Procedure
Intervention Name(s)
Patients undergoing ACL reconstruction with or without a tourniquet
Intervention Description
Patients undergoing ACL reconstruction with or without a tourniquet
Primary Outcome Measure Information:
Title
Limb symmetry index (LSI)
Description
Limb symmetry index (LSI) of the peak torque of the quadriceps
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Arthroscopic visibility
Description
Arthroscopic visibility
Time Frame
during surgery
Title
Operative time
Description
Operative time
Time Frame
during surgery
Title
Intra-operative opioid requirements
Description
Intra-operative opioid requirements (in morphine milligram equivalents (MMEs)
Time Frame
during surgery
Title
PACU opioid requirements
Description
PACU opioid requirements (MMEs)
Time Frame
during surgery
Title
Post-operative pain in PACU
Description
Post-operative pain in PACU measured by a Numeric Rating Scale
Time Frame
during surgery
Title
LSI of peak strength and rate of torque development of the quadriceps
Description
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
Time Frame
6 weeks
Title
LSI of peak strength and rate of torque development of the quadriceps
Description
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
Time Frame
6 months
Title
Quadriceps circumference
Description
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.
Time Frame
preoperative, 2 weeks, 6 weeks, 3 months and 6 months
Title
Number of days post-operatively until the patient can complete a straight leg raise with no extensor lag at physical therapy.
Description
Number of days post-operatively until the patient can complete a straight leg raise with no extensor lag at physical therapy.
Time Frame
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
Title
Number of days post-operatively until the patient can actively hyper-extend their knee at physical therapy.
Description
Number of days post-operatively until the patient can actively hyper-extend their knee at physical therapy.
Time Frame
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
Title
IKDC and the Marx Activity Rating Scale scores
Description
subjective knee evaluation
Time Frame
6 weeks
Title
IKDC and the Marx Activity Rating Scale scores
Description
subjective knee evaluation
Time Frame
1 year
Title
Limb symmetry index (LSI)
Description
Limb symmetry index (LSI) of the peak torque of the quadriceps
Time Frame
6 weeks
Title
Limb symmetry index (LSI)
Description
Limb symmetry index (LSI) of the peak torque of the quadriceps
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Sex
Description
Sex
Time Frame
preoperative
Title
Race
Description
Race
Time Frame
preoperative
Title
Ethnicity
Description
Ethnicity
Time Frame
preoperative
Title
Body Mass Index (BMI)
Description
Body Mass Index (BMI)
Time Frame
preoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing an arthroscopic assisted ACLR using a bone-tendon-bone patellar tendon autograft. 18 years or older English speaking Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caleb Michalek, BS
Phone
7043233698
Email
caleb.michalek@orthocarolina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Riboh, MD
Organizational Affiliation
OrthoCarolina Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
OrthoCarolina Research Institute, Inc.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caleb Michalek, BS
Phone
704-323-3698
Email
caleb.michalek@orthocarolina.com
First Name & Middle Initial & Last Name & Degree
Jonathan Riboh, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30582107
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.
Results Reference
background
PubMed Identifier
10522577
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.
Results Reference
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PubMed Identifier
25786826
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.
Results Reference
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PubMed Identifier
28830402
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.
Results Reference
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PubMed Identifier
23809456
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.
Results Reference
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PubMed Identifier
27672574
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.
Results Reference
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PubMed Identifier
24371536
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
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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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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.
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Results Reference
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Tourniquet Use in Anterior Cruciate Ligament Repair

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