Clinical trial NCT05735236: Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation
Official title: Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACL Tear
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 78
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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. Exclusion criteria will be evaluated via the medical record as well as by the expert opinion of the physician.

      3. If at any point in the study a subject develops one of the above contraindications, they will be removed from the study.

      4. If a subject becomes pregnant while participating in the intervention portion of the study, they will be removed.

Primary outcomes:
measure: Knee extensor strength
timeFrame: 6 months
Secondary outcomes:
measure: hamstrings musculature strength
timeFrame: 6 months
measure: single leg squat test
timeFrame: 6 months
measure: Tegner Activity Scale
timeFrame: 6 months
measure: LEFS
timeFrame: 2 years
measure: Pain NPRS
timeFrame: 2 Years
measure: PROMIS Pain
timeFrame: 2 Years
measure: PROMIS Physical Function
timeFrame: 2 Years
measure: Brief Resiliency Score (BRS)
timeFrame: 2 Years
measure: ACL-RSI
timeFrame: 2 Years
measure: IKDC
timeFrame: 2 Years
Other outcomes:
Locations:
city: Centennial
country: United States
facility: UCHealth Steadman Hawkins Clinic
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: James Genuario, MD
role: PRINCIPAL_INVESTIGATOR
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