Health Trials

About this trial

This research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability.

Eligibility criteria

Qualifiers

Diagnosis of traumatic patellar instability (either primary or recurrent) determined by an American Board of Family Medicine certified physician with a Certificate of Added Qualifications in Sports Medicine or licensed Physical Therapist utilizing clinical examination, radiographic imaging, and patients' reports of instability

Age 14 to 40 years

Skeletally mature with closed growth plates visualized by radiograph

A score of 80 or more on the Sports Activity Scale, which corresponds to participating in "running, twisting, turning (tennis, racquetball, handball, ice hockey, field hockey, skiing, wrestling)" at least 1-3 times per week

Disqualifiers

Concomitant osteochondral lesion requiring surgical fixation

Radiographic evidence of osteoarthritis (< Kellgren-Lawrence Grade 2)

Previous ipsilateral or contralateral knee surgery

Most recent instability event more than 3 months before enrollment

Trial design

Treatments tested in this trial

  • Blood Flow Restriction Training
  • Sham Blood Flow Restriction Training

Treatment groups

78 Participants
are divided into 2 treatment groups

Locations

4
UK Healthcare at Turfland40504, LexingtonKentucky, United States
University of Kentucky Biomotion Laboratory40536, LexingtonKentucky, United States
Center for Sports Performance and Research02035, FoxboroughMassachusetts, United States
Foxboro Sports Medicine Clinic02035, FoxboroughMassachusetts, United States

Sponsors and collaborators

Caitlin Conley

Lead sponsor

University of Kentucky

Sponsor institution

The Cleveland Clinic

Collaborator

Source ClinicalTrials.gov