Blood Flow Restriction Training, Aspiration, and Intraarticular Normal Saline

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study is designed to allow health care professionals and researchers to answer many questions about whether either an injection of saline (salt water) in the knee or a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery after patellar dislocation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cale Jacobs, PhD
• Collaborator: The Cleveland Clinic

Criteria

Inclusion Criteria:

• Diagnosis of traumatic patellar dislocation (either primary or recurrent) determined by an American Board of Family Medicinecertified physician with a Certificate of Added Qualifications in Sports Medicine 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

• Desire to resume pre-injury activity level

Exclusion Criteria:

• Patellar subluxation but not dislocation

• 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

• History of intra-articular injection into either knee within 3 months

• History of any inflammatory disorder

• BMI > 35 kg/m2

• Diabetes or uncontrolled hypertension

• Varicose veins or a history of personal or immediate family history (parental or sibling) of deep vein thrombosis

• Pre-existing conditions or previous surgeries that effect the ability to walk

• Planned trips or vacations that will result in the inability to attend 4 consecutive physical therapy sessions