ACL Tear
Conditions
Brief summary
The aim of this study is to investigate the efficacy of blood flow restriction (BFR) therapy in post-operative rehabilitation following knee arthroscopy for primary ACL reconstruction. BFR has been shown to effect time to return to activity and strength postoperatively. This study aims to analyze the effects of BFR therapy in patients who underwent primary ACL reconstruction surgery compared to controls. Participants will be randomized into either a treatment (BFR Cuff) or control (no BFR cuff) group. All participants will follow standard of care (SOC) physical therapy protocol for 12 weeks after surgery according to their treatment group. Strength and patient outcome measures will be recorded throughout the 2 year study period.
Detailed description
The aim of this study is to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following knee arthroscopy. The current standard of care and post-operative pain levels can limit patients from applying load necessary to increase muscle size and strength development due to partial weight baring after surgery. We hypothesize that immediate and consistent use of BFR augmenting our current standard post operative knee arthroscopy rehabilitation protocol will result in greater improvement in strength and quicker achievement of phase-based rehabilitation goals. We hypothesize that these objective improvements in strength will correlate with clinically meaningful improvement in Tegner activity scale, International Knee Documentation Committee (IKDC), return to sport, Lower Extremity Functional Scale (LEFS), pain and resiliency (patient reported outcome, PRO) scores indicative of greater functional recovery compared to our standard rehabilitation protocol alone.
Interventions
DEVICEBFR Cuff
The BFR cuff will be applied to the proximal thigh of the surgical leg while the patient completes specified physical therapy exercises.80% occlusion pressure will be determined by PT's in clinic through the use of a Delphi unit. Subjects will then be able to use the Saga Fitness app to adjust this pressure if it differs from the automatic calibrated pressure.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing primary knee arthroscopy for ACL reconstruction without meniscus repair * Completing initial 12 weeks of physical therapy at the Steadman Hawkins Clinic in Denver * Patients with access to smartphone device
Exclusion criteria
* Bilateral knee surgeries to be performed within 12 weeks of each other * Patients received meniscus repairs, chondral lesion repair/transplants, * Prior surgery on the same knee * Anyone who meets the following contraindications for BFR therapy: * Deep Vein Thrombosis (DVT) * Pulmonary Embolism * Hemorrhagic/Thrombolytic Stroke * Clotting Disorders * Hemophilia or taking blood thinners * Pregnant or up to 6 months post-partum * Untreated Hypertension * Untreated Hypotension * Rhabdomyolysis or recent traumatic injury 2\.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee extensor strength | 6 months | Strength of knee extensors via handheld dynamometry (HHD) and reported as a measure of limb symmetry index (LSI) comparing operative limb to non-operative lim |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hamstrings musculature strength | 6 months | Strength of knee flexors via handheld dynamometry (HHD) and reported as a measure of limb symmetry index (LSI) comparing operative limb to non-operative limb. |
| single leg squat test | 6 months | Performance on a Repeated Single Leg Squat test to 45 deg knee flexion over the course of 90 seconds reported as a measure of LSI |
| Tegner Activity Scale | 6 months | Tegner Activity Scale: Range 0 (disability because of knee problems) - 10 (national or international level soccer) |
| LEFS | 2 years | Range 0 (extreme difficulty) -100 (nodifficulty);MDIC = Δ 123 |
| Pain NPRS | 2 Years | Range 1 (low pain) -10 (high pain); MDC = Δ 34 |
| PROMIS Pain | 2 Years | Range 0 (low pain) -100 (highpain); MDC = Δ 85 |
| PROMIS Physical Function | 2 Years | Range 0 (low function) -100 (high function); MDC = Δ 85 |
| Brief Resiliency Score (BRS) | 2 Years | Range 1(low resilience) -5 (high resilience); MDC = Δ low (1-2.99) to normal (3-4.3) to high (4.31-5) |
| ACL-RSI | 2 Years | Range 1 (low function) -100 (high function); MDC = ∆15.1 for short form version |
| IKDC | 2 Years | Range 1 (low function) -100 (high function); MDC = ∆8.8 low to ∆15.6 high |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStephanie Mayer, MD
University of Colorado, Denver
Outcome results
None listed