Blood Flow Restriction Following Hip Arthroscopy

Postoperative Blood Flow Restriction Training Following Hip Arthroscopy: A Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Labral Tear, Glenoid; Femoral Acetabular Impingement
• Intervention / Treatment: Behavioral: Sham BFR Rehabilitative Therapy; Behavioral: Blood Flow Restriction Rehabilitative Therapy

Detailed Description

The investigators propose using standardized strength testing, serial quadriceps measurements, and MRI to assess the efficacy of BFR training in increasing muscle hypertrophy following hip arthroscopy. Investigators will perform a randomized double-blinded placebo-controlled controlled trial of patients undergoing primary hip arthroscopy. Quadriceps strength will be measured with dynamometers at 3, 6, and 12 month time points, with Biodex strength testing at 6 and 12 months, postoperatively. Additionally, standardized circumferential leg measurements to assess quadriceps hypertrophy will be performed at 1, 3, 6 and 12-month time points. Patients will also undergo a hip MRI at 6 months postoperatively to quantify muscle size and appearance about the hip joint. Patient reported outcomes including standard outcomes measures at 3, 6, and 12 months and return to work/sport data will also be collected at standard time points. Patients will also be followed longitudinally for rates of reinjury, return to work, and return to sport.

This study will evaluate the efficacy of BFR therapy in the postoperative period of primary hip arthroscopy to improve muscle hypertrophy during the short-term rehabilitation period. This will be directly measured by strength testing with dynamometers and Biodex testing. Other metrics will include standard validated patient reported outcomes at 3, 6 and 12 month time points including hip disability and osteoarthritis outcome score (HOOS), Harris Hip score (HHS), visual analog scale (VAS) for pain, international hip outcome tool (iHOT-12), and Hip outcome score (HOS), and return to sport questionnaires. Standardized serial circumferential thigh measurements will also be recorded at each visit, in additional to a one time MRI at 6 months postoperatively.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carla M. Edwards, PhD; Phone Number: 312-563-5735; Email: carla_edwards@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Carla M Edwards, PhD; Phone Number: 312-563-5735; Email: carla_edwards@rush.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; The control group will receive sham BFR, in which a non-occlusive pressure is applied with the cuff. The exercises performed will be identical to the BFR group.	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.
Experimental: BFR Postoperative Rehabilitation; The experimental group will receive BFR postoperative rehabilitation, which will involve performing a series of blood flow restriction exercises identical to the control group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps Strength	Will be measured with dynamometer	3 month time point
Quadriceps Strength	Will be measured with dynamometer	6 month time point
Quadriceps Strength	Will be measured with dynamometer	12 month time point
Biodex strength testing	Isokinetic strength testing	6 month time point
Biodex strength testing	Isokinetic strength testing	12 month time point
Standardized circumferential leg meaurements	To assesss quadricep hypertrophy	1 month time point
Standardized circumferential leg meaurements	To assesss quadricep hypertrophy	3 month time point
Standardized circumferential leg meaurements	To assesss quadricep hypertrophy	6 month time point
Standardized circumferential leg meaurements	To assesss quadricep hypertrophy	12 month time point
Muscle size and appearance about the hip joint	To be assessed via hip MRI postoperatively	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip Disability and Osteoarthritis Outcome Score	Used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process.	3 month time point
Hip Disability and Osteoarthritis Outcome Score	Used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process.	6 month time point
Hip Disability and Osteoarthritis Outcome Score	Used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process.	12 month time point
Harris Hip Score	Gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.	3 month time point
Harris Hip Score	Gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.	6 month time point
Harris Hip Score	Gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.	12 month time point
Visual Analog Scale for pain	A 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."	3 month time point
Visual Analog Scale for pain	A 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."	6 month time point
Visual Analog Scale for pain	A 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."	12 month time point
International hip outcome tool	Comprised of 33 questions relating to: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns	3 month time point
International hip outcome tool	Comprised of 33 questions relating to: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns	6 month time point
International hip outcome tool	Comprised of 33 questions relating to: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns	12 month time point
Hip Outcome Score	A self-administered questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items.	3 month time point
Hip Outcome Score	A self-administered questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items.	6 month time point
Hip Outcome Score	A self-administered questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items.	12 month time point

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Jorge Chahla, MD PhD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Estimated): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Joint Diseases; Rupture; Tendon Injuries; Pathological Conditions, Signs and Symptoms; Rotator Cuff Injuries; Femoracetabular Impingement
• Other Study ID Numbers: 19093005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No