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
About this trial
This is an interventional treatment trial for Labral Tear, Glenoid
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
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
NCT ID
NCT04113759
First Posted
October 1, 2019
Last Updated
March 27, 2023
Sponsor
Rush University Medical Center
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
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