Labral Tear, GlenoidNCT04113759
Blood Flow Restriction Following Hip Arthroscopy
A study testing Blood Flow Restriction Rehabilitative Therapy in people with Labral Tear, Glenoid and Femoral Acetabular Impingement, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Labral Tear, Glenoid, Femoral Acetabular Impingement
- What is being tested?
- Blood Flow Restriction Rehabilitative Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Carla M Edwards, PhD, 312-563-5735, carla_edwards@rush.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Blood Flow Restriction Rehabilitative Therapy, Sham BFR Rehabilitative Therapy
- Medical subject headings
- Rotator Cuff Injuries, Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction Rehabilitative TherapyBehavioural
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 TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Blood Flow Restriction Rehabilitative Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Strength
Will be measured with dynamometer
Measured: 3 month time point
Quadriceps Strength
Will be measured with dynamometer
Measured: 6 month time point
Quadriceps Strength
Will be measured with dynamometer
Measured: 12 month time point
Biodex strength testing
Isokinetic strength testing
Measured: 6 month time point
Biodex strength testing
Isokinetic strength testing
Measured: 12 month time point
Standardized circumferential leg meaurements
To assesss quadricep hypertrophy
Measured: 1 month time point
Standardized circumferential leg meaurements
To assesss quadricep hypertrophy
Measured: 3 month time point
Standardized circumferential leg meaurements
To assesss quadricep hypertrophy
Measured: 6 month time point
Standardized circumferential leg meaurements
To assesss quadricep hypertrophy
Measured: 12 month time point
Muscle size and appearance about the hip joint
To be assessed via hip MRI postoperatively
Measured: 6 months postoperatively
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 month time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Aug 2023
- Primary completionNov 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labral Tear, GlenoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Chahla, MD PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113759
- Sponsor's protocol ID
- 19093005
- Status last verified
- Dec 2025
- First submitted
- 1 Oct 2019
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Blood Flow Restriction Training Following Hip Arthroscopy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04113759
- Acronym / sponsor ID
- 19093005
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Behavioral: Sham BFR Rehabilitative TherapyThe 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. |
| BFR Postoperative Rehabilitation | Experimental | Behavioral: Blood Flow Restriction Rehabilitative TherapyThe experimental group will receive BFR postoperative rehabilitation, which will involve performing a series of blood flow restriction exercises identical to the control group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction Rehabilitative TherapyBFR 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. | Behavioural | BFR Postoperative Rehabilitation |
| Sham BFR Rehabilitative TherapyThe 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. | Behavioural | Control Group |
Primary outcome
Quadriceps Strength
Time frame: 3 month time point
Will be measured with dynamometer
Quadriceps Strength
Time frame: 6 month time point
Will be measured with dynamometer
Quadriceps Strength
Time frame: 12 month time point
Will be measured with dynamometer
Biodex strength testing
Time frame: 6 month time point
Isokinetic strength testing
Biodex strength testing
Time frame: 12 month time point
Isokinetic strength testing
Standardized circumferential leg meaurements
Time frame: 1 month time point
To assesss quadricep hypertrophy
Standardized circumferential leg meaurements
Time frame: 3 month time point
To assesss quadricep hypertrophy
Standardized circumferential leg meaurements
Time frame: 6 month time point
To assesss quadricep hypertrophy
Standardized circumferential leg meaurements
Time frame: 12 month time point
To assesss quadricep hypertrophy
Muscle size and appearance about the hip joint
Time frame: 6 months postoperatively
To be assessed via hip MRI postoperatively
15 secondary outcomes
Hip Disability and Osteoarthritis Outcome Score
Time frame: 3 month time point
Hip Disability and Osteoarthritis Outcome Score
Time frame: 6 month time point
Hip Disability and Osteoarthritis Outcome Score
Time frame: 12 month time point
Harris Hip Score
Time frame: 3 month time point
Harris Hip Score
Time frame: 6 month time point
Harris Hip Score
Time frame: 12 month time point
Visual Analog Scale for pain
Time frame: 3 month time point
Visual Analog Scale for pain
Time frame: 6 month time point
Visual Analog Scale for pain
Time frame: 12 month time point
International hip outcome tool
Time frame: 3 month time point
International hip outcome tool
Time frame: 6 month time point
International hip outcome tool
Time frame: 12 month time point
Hip Outcome Score
Time frame: 3 month time point
Hip Outcome Score
Time frame: 6 month time point
Hip Outcome Score
Time frame: 12 month time point
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Recruiting
Hip Arthroscopy Postoperative Opioid Demands
Opioid Use, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jorge Chahla, MD PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Rehabilitative Therapy in people with Labral Tear, Glenoid and Femoral Acetabular Impingement, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carla M. Edwards, PhD (312-563-5735, carla_edwards@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Strength (time frame: 3 month time point). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.