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NCT Number: NCT04113759

Blood Flow Restriction Following Hip Arthroscopy

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Carla M Edwards, PhD

CONTACT

[email protected]

312-563-5735

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Quadriceps Strength

    Time frame: 3 month time point

    Will be measured with dynamometer

  2. Quadriceps Strength

    Time frame: 6 month time point

    Will be measured with dynamometer

  3. Quadriceps Strength

    Time frame: 12 month time point

    Will be measured with dynamometer

  4. Biodex strength testing

    Time frame: 6 month time point

    Isokinetic strength testing

  5. Biodex strength testing

    Time frame: 12 month time point

    Isokinetic strength testing

  6. Standardized circumferential leg meaurements

    Time frame: 1 month time point

    To assesss quadricep hypertrophy

  7. Standardized circumferential leg meaurements

    Time frame: 3 month time point

    To assesss quadricep hypertrophy

  8. Standardized circumferential leg meaurements

    Time frame: 6 month time point

    To assesss quadricep hypertrophy

  9. Standardized circumferential leg meaurements

    Time frame: 12 month time point

    To assesss quadricep hypertrophy

  10. Muscle size and appearance about the hip joint

    Time frame: 6 months postoperatively

    To be assessed via hip MRI postoperatively

Secondary outcomes

  1. Hip Disability and Osteoarthritis Outcome Score

    Time frame: 3 month time point

    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.

  2. Hip Disability and Osteoarthritis Outcome Score

    Time frame: 6 month time point

    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. Hip Disability and Osteoarthritis Outcome Score

    Time frame: 12 month time point

    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.

  4. Harris Hip Score

    Time frame: 3 month time point

    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.

  5. Harris Hip Score

    Time frame: 6 month time point

    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. Harris Hip Score

    Time frame: 12 month time point

    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.

  7. Visual Analog Scale for pain

    Time frame: 3 month time point

    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."

  8. Visual Analog Scale for pain

    Time frame: 6 month time point

    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."

  9. Visual Analog Scale for pain

    Time frame: 12 month time point

    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."

  10. International hip outcome tool

    Time frame: 3 month time point

    Comprised of 33 questions relating to:

    Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns

  11. International hip outcome tool

    Time frame: 6 month time point

    Comprised of 33 questions relating to:

    Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns

  12. International hip outcome tool

    Time frame: 12 month time point

    Comprised of 33 questions relating to:

    Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns

  13. Hip Outcome Score

    Time frame: 3 month time point

    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.

  14. Hip Outcome Score

    Time frame: 6 month time point

    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.

  15. Hip Outcome Score

    Time frame: 12 month time point

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carla M. Edwards, PhD

CONTACT

[email protected]

312-563-5735

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 3, 2019
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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