Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

Not Applicable

Recruiting

• Conditions: ACL Tear
• Interventions: Device: BFR Cuff

• Registration Number: NCT05735236
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2022-11-08
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-11-08
• Study Completion: 2025-11-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BFR Cuff	BFR Cuff	Patients undergo standard post-operative physical therapy as prescribed by their surgeon with the addition of a Blood Flow Restriction (BFR) cuff that is used during their exercises.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PROMIS Physical Function	2 Years	Range 0 (low function) -100 (high function); MDC = Δ 85
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.
Pain NPRS	2 Years	Range 1 (low pain) -10 (high pain); MDC = Δ 34
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
Tegner Activity Scale	6 months	Tegner Activity Scale: Range 0 (disability because of knee problems) - 10 (national or international level soccer)
PROMIS Pain	2 Years	Range 0 (low pain) -100 (highpain); 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)
LEFS	2 years	Range 0 (extreme difficulty) -100 (nodifficulty);MDIC = Δ 123
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

Trial Locations

Locations (1)

UCHealth Steadman Hawkins Clinic; 🇺🇸 Centennial, Colorado, United States