Actively Recruiting

Phase Not Applicable
Age: 16Years - 60Years
All Genders
ID05735236

Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

Led by University of Colorado, Denver · Updated on 2025-05-08

78

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of blood flow restriction (BFR) therapy during rehabilitation after knee arthroscopy for primary ACL reconstruction. This study compares the use of BFR therapy combined with standard physical therapy to standard therapy alone, aiming to see if BFR can improve muscle strength and speed up recovery. The study tracks strength and patient outcomes over a two-year period to better understand BFR's impact on post-operative rehabilitation. Participants will be randomly assigned to two groups: one receiving standard post-operative physical therapy with a BFR cuff applied during exercises, and the other receiving standard therapy without the cuff. The BFR cuff is placed on the upper thigh of the surgical leg and uses a set pressure adjusted through an app. All participants will follow a 12-week rehabilitation program after surgery based on their assigned group. During the study, participants will have strength measurements, including knee extensor and hamstring strength, and functional tests like a single leg squat assessed at 6 months. Patient-reported outcomes such as activity scales, pain levels, physical function, resilience, and knee-specific questionnaires will be collected up to 2 years. The study includes regular monitoring to track progress and safety throughout the rehabilitation process and beyond.

CONDITIONS

Brief Title

Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

Who Can Participate

Age: 16Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Age between 16 and 60 years
Not Eligible

You will not qualify if you...

  • Bilateral knee surgeries planned within 12 weeks of each other
  • Patients who received meniscus repairs or chondral lesion repair/transplants
  • Prior surgery on the same knee
  • Contraindications for BFR therapy including deep vein thrombosis, pulmonary embolism, hemorrhagic/thrombolytic stroke, clotting disorders, hemophilia or use of blood thinners
  • Pregnant or up to 6 months postpartum
  • Untreated hypertension or hypotension
  • Rhabdomyolysis or recent traumatic injury
  • Development of any contraindications during the study leads to removal
  • Pregnancy during intervention leads to removal

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 12 weeks

Participants undergo standard post-operative physical therapy prescribed by their surgeon. Those in the intervention group use a Blood Flow Restriction (BFR) cuff on the surgical leg during specified exercises to augment rehabilitation.

Weekly visits for physical therapy sessions

Post-operative Follow-up

Duration - Up to 2 years

Participants are assessed for functional recovery, strength, pain, and other patient-reported outcomes over the long term following the rehabilitation period.

Periodic follow-up visits up to 2 years

Trial Site Locations

Total: 1 location

1

UCHealth Steadman Hawkins Clinic

Centennial, Colorado, United States, 80111

Actively Recruiting

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Research Team

L

Lauren Heylmun, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial.

Eric N Bowman, Rami Elshaar, Heather Milligan...

https://pubmed.ncbi.nlm.nih.gov/30638439

A SYSTEMATIC REVIEW OF THE EFFECTS OF BLOOD FLOW RESTRICTION TRAINING ON QUADRICEPS MUSCLE ATROPHY AND CIRCUMFERENCE POST ACL RECONSTRUCTION.

Derek Charles, Ryan White, Caleb Reyes...

https://pubmed.ncbi.nlm.nih.gov/33344004

The Patient Acceptable Symptomatic State for the Modified Harris Hip Score and Hip Outcome Score Among Patients Undergoing Surgical Treatment for Femoroacetabular Impingement.

Jaskarndip Chahal, Geoffrey S Van Thiel, Richard C Mather...

https://pubmed.ncbi.nlm.nih.gov/26078452

Psychometric Properties of the Dance Functional Outcome Survey (DFOS): Reliability, Validity, and Responsiveness.

Shaw Bronner, Evie Chodock, Igor Edwardo Reis Urbano...

https://pubmed.ncbi.nlm.nih.gov/30053790