Blood Flow Restriction Following Hip Arthroscopy

NCT04113759 | Recruiting

• 1 other identifier: 19093005
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labral Tear, Glenoid; Femoral Acetabular Impingement

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (15)

• Hip Disability and Osteoarthritis Outcome Score

  3 month time point

• Hip Disability and Osteoarthritis Outcome Score

  6 month time point

• Hip Disability and Osteoarthritis Outcome Score

  12 month time point

• Harris Hip Score

  3 month time point

• Harris Hip Score

  6 month time point

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

BFR Postoperative Rehabilitation

EXPERIMENTAL

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

Interventions

Blood Flow Restriction Rehabilitative Therapy BEHAVIORAL

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.

BFR Postoperative Rehabilitation

Sham BFR Rehabilitative Therapy BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries; Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jorge Chahla, MD PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla M. Edwards, PhD

CONTACT

312-563-5735; carla_edwards@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: August 1, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)