ACL - Anterior Cruciate Ligament Deficiency, ACL Injury, ACL Tear
Conditions
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: 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.
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.
Interventions
PROCEDUREPatients undergoing ACL reconstruction with or without a tourniquet
Patients undergoing ACL reconstruction with or without a tourniquet
Sponsors
OrthoCarolina Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Treating physicians and subjects will be blinded to treatment group.
Intervention model description
Double-blinded randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limb symmetry index (LSI) | 6 months | Limb symmetry index (LSI) of the peak torque of the quadriceps |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arthroscopic visibility | during surgery | Arthroscopic visibility |
| Operative time | during surgery | Operative time |
| Intra-operative opioid requirements | during surgery | Intra-operative opioid requirements (in morphine milligram equivalents (MMEs) |
| PACU opioid requirements | during surgery | PACU opioid requirements (MMEs) |
| Post-operative pain in PACU | during surgery | Post-operative pain in PACU measured by a Numeric Rating Scale |
| LSI of peak strength and rate of torque development of the quadriceps | 6 weeks | 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 | preoperative, 2 weeks, 6 weeks, 3 months and 6 months | 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. | 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 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. | 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. |
| IKDC and the Marx Activity Rating Scale scores | 6 weeks | subjective knee evaluation |
| Limb symmetry index (LSI) | 6 weeks | Limb symmetry index (LSI) of the peak torque of the quadriceps |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathan Riboh, MD
OrthoCarolina Research Institute, Inc.
Outcome results
None listed