Tourniquet Use in Anterior Cruciate Ligament Repair

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Procedure: Patients undergoing ACL reconstruction with or without a tourniquet


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blinded randomized controlled clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients undergoing patellar bone-tendon-bone autograft ACL reconstruction with a tourniquet used for the duration of the case. | |
| Active Comparator: Treatment/Intervention<br>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<br>* Patients undergoing ACL reconstruction with or without a tourniquet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb symmetry index (LSI) | Limb symmetry index (LSI) of the peak torque of the quadriceps | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthroscopic visibility | Arthroscopic visibility | during surgery | 
| Operative time | Operative time | during surgery | 
| Intra-operative opioid requirements | Intra-operative opioid requirements (in morphine milligram equivalents (MMEs) | during surgery | 
| PACU opioid requirements | PACU opioid requirements (MMEs) | during surgery | 
| Post-operative pain in PACU | Post-operative pain in PACU measured by a Numeric Rating Scale | during surgery | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| IKDC and the Marx Activity Rating Scale scores | subjective knee evaluation | 6 weeks | 
| IKDC and the Marx Activity Rating Scale scores | subjective knee evaluation | 1 year | 
| Limb symmetry index (LSI) | Limb symmetry index (LSI) of the peak torque of the quadriceps | 6 weeks | 
| Limb symmetry index (LSI) | Limb symmetry index (LSI) of the peak torque of the quadriceps | 3 months |