Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

Not Applicable

Recruiting

• Conditions: Muscle Weakness; Muscle Atrophy
• 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.

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: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-11-08
• Study Completion: 2025-11-08

Recruitment & Eligibility

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

Inclusion Criteria

• Patients with ACL reconstruction with quadriceps, hamstring, bone-patellar-bone or allograft graft, with/without meniscectomies. Patients must also have access to a smartphone device in order to utilize the SAGA BFR application for use. The application is free to use.

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Exclusion Criteria

• Bilateral knee surgeries to be performed within 12 weeks of each other, meniscus repairs, chondral lesion repair/transplants, ACL revisions that utilize contralateral autografts, MCL repairs, and the following BFR contraindications: deep vein thrombosis (DVT), pulmonary embolism, hemorrhagic/thrombolytic stroke, clotting disorders, hemophilia or taking blood thinners, pregnant or up to 6 months postpartum, untreated hypertension, untreated hypotension, rhabdomyolysis or recent traumatic injury, does not understand English, and the following BFR contraindications:

  1. Contraindications for BFR

     • 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.

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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