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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
34
Patients undergoing ACL reconstruction with or without a tourniquet
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, United States
Limb symmetry index (LSI)
Limb symmetry index (LSI) of the peak torque of the quadriceps
Time frame: 6 months
Arthroscopic visibility
Arthroscopic visibility
Time frame: during surgery
Operative time
Operative time
Time frame: during surgery
Intra-operative opioid requirements
Intra-operative opioid requirements (in morphine milligram equivalents (MMEs)
Time frame: during surgery
PACU opioid requirements
PACU opioid requirements (MMEs)
Time frame: during surgery
Post-operative pain in PACU
Post-operative pain in PACU measured by a Numeric Rating Scale
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
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
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.
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
IKDC and the Marx Activity Rating Scale scores
subjective knee evaluation
Time frame: 6 weeks
IKDC and the Marx Activity Rating Scale scores
subjective knee evaluation
Time frame: 1 year
Limb symmetry index (LSI)
Limb symmetry index (LSI) of the peak torque of the quadriceps
Time frame: 6 weeks
Limb symmetry index (LSI)
Limb symmetry index (LSI) of the peak torque of the quadriceps
Time frame: 3 months
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