Overview

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