Anterior Cruciate Ligament Tear, Knee Injuries, Sport Injury
Conditions
Brief summary
Evaluating the use of peri-operative blood flow restriction therapy surrounding anterior cruciate ligament tear
Detailed description
The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy both before and after anterior cruciate ligament reconstruction (ACLR) following a tear. BFR has been proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia. Muscle atrophy occurs following ACL tear and reconstruction. Thus, physical therapy is used in the peri-operative period to regain strength with the ultimate goal of returning to activity. The goal of this investigation is to determine if using BFR during perioperative therapy would lead to increased and expedited strength gains. Additionally we would like to determine if BFR helps patients to pass the standard rehabilitative functional tests and return to play sooner. We will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding ACL tear and reconstruction.
Interventions
DEVICEBlood flood restriction cuff
Blood flow restriction cuffs will be used as an augment to physical therapy
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participant and investigator will be aware of treatment arm allocation. Outcomes will be assessed in a masked fashion
Intervention model description
Parallel randomized controlled trial with a treatment and control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* ACL tear undergoing reconstruction
Exclusion criteria
* History of pulmonary embolism * History of deep vein thrombosis * Family history of PE/DVT * Hypercoaguable disorder * Multiligamentous knee injury * Neurovascular injury * Peripheral vascular disease * Unable to complete physical therapy * Unable to tolerate blood flow restriction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Strength | Three months | Quadriceps strength via handheld dynamometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Strength | six months | Quadriceps strength via handheld dynamometer |
| Knee range of motion | three months | Knee range of motion via goniometer |
| Patient reported outcome measurement information system | Three months | Patient reported outcomes measurement information system score on patient physical function, scale 0-100 with higher scores better |
| international knee documentation committee questionnaire | three months | international knee documentation committee questionnaire, scale 0-100 with higher scores better |
| Pain scores | three months | Visual analog scale pain scores, scale 0-10 higher is more pain |
| Patient reported outcomes measurement information system | Six months | Patient reported outcomes measurement information system score on patient physical function, scale 0-100 with higher scores better |
Countries
United States
Outcome results
None listed