NCT04113759 · Rush University Medical Center
Blood Flow Restriction Following Hip Arthroscopy
What this study is about
This study will be a forward-looking randomly assigned, double-blinded, compared against an inactive treatment trial of patients undergoing primary hip arthroscopy for FAIS and/or labral pathology. All patients who sign the consent form will be enrolled in the study and randomly assigned to one of the two treatment treatment group$1.
View original scientific description
This study will be a prospective randomized, double-blinded, placebo-controlled trial of patients undergoing primary hip arthroscopy for FAIS and/or labral pathology. All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. Follow-up will take place at 1-month, 3-months, 6-months, and 1-year.
Interventions
BEHAVIORAL
Blood Flow Restriction Rehabilitative Therapy
BFR cuffs placed at the proximal thigh, just inferior to the greater trochanter. Inflation time not to exceed 20 minutes. One BFR session per treatment. BFR exercise dosage: 4 sets of the following repetitions 30, 15, 15, 15, 30 second rest between sets, 1 min rest between exercises. Progress exercise if pain \<2/10 on VAS and RPE \<5 on 0-10 scale. (Heerey et al), and no break down in form.
BEHAVIORAL
Sham BFR Rehabilitative Therapy
The schedule, type of exercises, repetition ranges, and other physical therapy interventions will be the same as the BFR experimental group - however a non-occlusive pressure will be applied with the cuff in the control group.
Primary outcome measures
Quadriceps Strength
Time frame: 3 month time point
Will be measured with dynamometer
Quadriceps Strength
Time frame: 6 month time point
Will be measured with dynamometer
Quadriceps Strength
Time frame: 12 month time point
Will be measured with dynamometer
Biodex strength testing
Time frame: 6 month time point
Isokinetic strength testing
Biodex strength testing
Time frame: 12 month time point
Isokinetic strength testing
Standardized circumferential leg meaurements
Time frame: 1 month time point
To assesss quadricep hypertrophy
Standardized circumferential leg meaurements
Time frame: 3 month time point
To assesss quadricep hypertrophy
Standardized circumferential leg meaurements
Time frame: 6 month time point
To assesss quadricep hypertrophy
Standardized circumferential leg meaurements
Time frame: 12 month time point
To assesss quadricep hypertrophy
Muscle size and appearance about the hip joint
Time frame: 6 months postoperatively
To be assessed via hip MRI postoperatively
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult patients 18-40
- English-speaking
- Clinical and radiographic examination (MRI) consistent FAIS and/or labral pathology, and are schedule for primary hip arthroscopy
- Written and informed consent for study participation
Exclusion criteria
- Patients younger than 18 or older than 40 years of age
- Non-native English speaker
- Revision surgery or prior history of ipsilateral hip or knee surgery
- Inability to comply with the proposed follow-up clinic visits
- Patients lacking decisional capacity
- Patients with a history of deep vein thrombosis, pulmonary embolism, or known clotting disorder or hypercoagulable state
- Pregnant or breast-feeding women. Pregnancy as determined by a positive pregnancy test prior to procedure. Females of childbearing potential must agree to use an acceptable birth control method during study participation.
- Worker's compensation patients
- Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
- Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2025 · Source of record for eligibility and locations