search
Back to results

Blood Flow Restriction Following Hip Arthroscopy

Primary Purpose

Labral Tear, Glenoid, Femoral Acetabular Impingement

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood Flow Restriction Rehabilitative Therapy
Sham BFR Rehabilitative Therapy
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labral Tear, Glenoid

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control Group

    BFR Postoperative Rehabilitation

    Arm Description

    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.

    The experimental group will receive BFR postoperative rehabilitation, which will involve performing a series of blood flow restriction exercises identical to the control group.

    Outcomes

    Primary Outcome Measures

    Quadriceps Strength
    Will be measured with dynamometer
    Quadriceps Strength
    Will be measured with dynamometer
    Quadriceps Strength
    Will be measured with dynamometer
    Biodex strength testing
    Isokinetic strength testing
    Biodex strength testing
    Isokinetic strength testing
    Standardized circumferential leg meaurements
    To assesss quadricep hypertrophy
    Standardized circumferential leg meaurements
    To assesss quadricep hypertrophy
    Standardized circumferential leg meaurements
    To assesss quadricep hypertrophy
    Standardized circumferential leg meaurements
    To assesss quadricep hypertrophy
    Muscle size and appearance about the hip joint
    To be assessed via hip MRI postoperatively

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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."
    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."
    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."
    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
    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
    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
    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.
    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.
    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.

    Full Information

    First Posted
    October 1, 2019
    Last Updated
    March 27, 2023
    Sponsor
    Rush University Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04113759
    Brief Title
    Blood Flow Restriction Following Hip Arthroscopy
    Official Title
    Postoperative Blood Flow Restriction Training Following Hip Arthroscopy: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rush University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labral Tear, Glenoid, Femoral Acetabular Impingement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    BFR Postoperative Rehabilitation
    Arm Type
    Experimental
    Arm Description
    The experimental group will receive BFR postoperative rehabilitation, which will involve performing a series of blood flow restriction exercises identical to the control group.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Blood Flow Restriction Rehabilitative Therapy
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Sham BFR Rehabilitative Therapy
    Intervention Description
    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 Measure Information:
    Title
    Quadriceps Strength
    Description
    Will be measured with dynamometer
    Time Frame
    3 month time point
    Title
    Quadriceps Strength
    Description
    Will be measured with dynamometer
    Time Frame
    6 month time point
    Title
    Quadriceps Strength
    Description
    Will be measured with dynamometer
    Time Frame
    12 month time point
    Title
    Biodex strength testing
    Description
    Isokinetic strength testing
    Time Frame
    6 month time point
    Title
    Biodex strength testing
    Description
    Isokinetic strength testing
    Time Frame
    12 month time point
    Title
    Standardized circumferential leg meaurements
    Description
    To assesss quadricep hypertrophy
    Time Frame
    1 month time point
    Title
    Standardized circumferential leg meaurements
    Description
    To assesss quadricep hypertrophy
    Time Frame
    3 month time point
    Title
    Standardized circumferential leg meaurements
    Description
    To assesss quadricep hypertrophy
    Time Frame
    6 month time point
    Title
    Standardized circumferential leg meaurements
    Description
    To assesss quadricep hypertrophy
    Time Frame
    12 month time point
    Title
    Muscle size and appearance about the hip joint
    Description
    To be assessed via hip MRI postoperatively
    Time Frame
    6 months postoperatively
    Secondary Outcome Measure Information:
    Title
    Hip Disability and Osteoarthritis Outcome Score
    Description
    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.
    Time Frame
    3 month time point
    Title
    Hip Disability and Osteoarthritis Outcome Score
    Description
    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.
    Time Frame
    6 month time point
    Title
    Hip Disability and Osteoarthritis Outcome Score
    Description
    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.
    Time Frame
    12 month time point
    Title
    Harris Hip Score
    Description
    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.
    Time Frame
    3 month time point
    Title
    Harris Hip Score
    Description
    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.
    Time Frame
    6 month time point
    Title
    Harris Hip Score
    Description
    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.
    Time Frame
    12 month time point
    Title
    Visual Analog Scale for pain
    Description
    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."
    Time Frame
    3 month time point
    Title
    Visual Analog Scale for pain
    Description
    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."
    Time Frame
    6 month time point
    Title
    Visual Analog Scale for pain
    Description
    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."
    Time Frame
    12 month time point
    Title
    International hip outcome tool
    Description
    Comprised of 33 questions relating to: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns
    Time Frame
    3 month time point
    Title
    International hip outcome tool
    Description
    Comprised of 33 questions relating to: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns
    Time Frame
    6 month time point
    Title
    International hip outcome tool
    Description
    Comprised of 33 questions relating to: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns
    Time Frame
    12 month time point
    Title
    Hip Outcome Score
    Description
    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.
    Time Frame
    3 month time point
    Title
    Hip Outcome Score
    Description
    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.
    Time Frame
    6 month time point
    Title
    Hip Outcome Score
    Description
    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.
    Time Frame
    12 month time point

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mukesh Ahuja, MBBS
    Phone
    312-563-2214
    Email
    mukesh.ahuja@rushortho.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jorge Chahla, MD PhD
    Organizational Affiliation
    Rush University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Blood Flow Restriction Following Hip Arthroscopy

    We'll reach out to this number within 24 hrs