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Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

ConditionACL Tear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-60
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Deep Vein Thrombosis (DVT)

Trial design

Design model

Parallel

Treatments tested in this trial

  • BFR Cuff

    Device

    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.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: BFR CuffActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Knee extensor strength

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

Time frame
6 months

Secondary outcomes

1

hamstrings musculature strength

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.

Time frame
6 months
2

single leg squat test

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

Time frame
6 months
3

Tegner Activity Scale

Tegner Activity Scale: Range 0 (disability because of knee problems) - 10 (national or international level soccer)

Time frame
6 months
4

LEFS

Range 0 (extreme difficulty) -100 (nodifficulty);MDIC = Δ 123

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Source ClinicalTrials.gov
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