Hip InjuriesNCT05165927
Comparison of Methods in Post Operative Hip Arthroscopy Rehabilitation
A study testing BFR in people with Hip Injuries, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators plan to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following hip arthroscopy. BFR has shown to be great at helping the recovery process. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hip Injuries
- What is being tested?
- BFR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2022to 31 Dec 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with labral tears, femoroacetabular impingement syndrome, loose bodies, ligamentum teres tears, and related intra-articular pathology to be treated with hip arthroscopy. Patients must also have access to a smartphone device in order to utilize the SAGA BFR application for use. The application is free to use.
Who cannot join
- bilateral hip surgeries to be performed within 12 weeks of each other, concomitant Peri-acetabular osteotomy, soft tissue repairs (hamstring, glute repairs), clinically diagnosed hip dysplasia, and the following BFR contraindications:
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism
- Hemorrhagic/Thrombolytic Stroke
- Clotting Disorders
- Hemophilia or taking blood thinners
Show all 10Show fewer
- Pregnant or up to 6 months post-partum
- Untreated Hypertension
- Untreated Hypotension
- Rhabdomyolysis or recent traumatic injury
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
UCHealth Steadman Hawkins Clinic Denver
Englewood, Colorado, 80012
Lauren Heylmun, BS, 720-516-9823, lauren.heylmun@cuanschutz.edu
About this study
The investigators plan to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following hip arthroscopy. BFR has shown to be great at helping the recovery process. SAGA is a well-known smart training technology company, and the investigators aim to partner with SAGA to use the BFR cuffs as the intervention method. The BFR cuff will be added to the current SOC for hip scope PT for the intervention group.
Read the detailed description
Study Design and Research Methods i. Timeline: Treatment Protocol duration 12 weeks per participant beginning post operative day 1 following hip arthroscopy. PRO's will be collected out to 2 years post-surgery and standard rehabilitation will follow the 12-week intervention period for both the control and experimental group. Study will be a 2-year timeline in total.
ii. Procedures: Patients will be randomized to control group, who will undergo Steadman Hawkins Clinic Denver's standard hip arthroscopy rehab protocol (see appendix) or to the intervention group, who will undergo standard rehab protocol with addition of BFR. Subjects will be randomized 1:1 for intervention vs. control and controlled for gender assigned at birth.
iii. Frequency of BFR Training: 6 days per week phase 1, 3 days per week phases 2 and 3 iv. Frequency of clinic visits PT: 1 day per week v. Intervention Group: The following exercises outlined are the specific exercises that will be performed in addition to SOC. Only these exercises will involve the use of the BFR cuff.
- Phase 1 (post operative weeks 1-3)
- Dosage: 80% limb occlusion pressure (LOP). 30x15x15x15 repetitions with 30 sec rests between sets. At least 1 min rest between exercises with occlusion OFF.
- Frequency: All 3 exercises performed at least 6 days per week. The first of these sessions will be performed in clinic supervised by PT to assess LOP and form prior to performance at home
- Exercises:
- Week 1: quadriceps set, gluteal set, hamstring set ii. Week 2: short arc quad, hook lying adduction/internal rotation isometric, hook lying abduction/external rotation isometric iii. Week 3: long arc quad, bridge, standing hamstring curl
- Phase 2 (weeks 4-6)
- Dosage: 80% LOP. 30x15x15x15 repetitions with 30 sec rests between sets. At least 1 min rest between exercises with occlusion OFF
- Frequency: All 3 resistive exercises performed at least 3 days per week. The first of these sessions will be performed in clinic supervised by PT to assess LOP and form prior to performance at home
- Exercises:
- Week 4: mini squat, prone hip extension over plinth, quadruped rock ii. Week 5: mid-range squat, modified single leg bridge foot on ball, heel slide strap assist iii. Week 6: step up, standing hip abduction, single leg bridge
- Phase 3 (weeks 6-12)
- Dosage: 80% LOP at 20-30% 1 RM.1 RM re-evaluated every 2 weeks to adjust resistance prescription. 30x15x15x15 repetitions with 30 sec rests between sets. At least 1 min rest between exercises with occlusion OFF b. Frequency: All 3 resistive exercises performed at least 3 days per week. The first of these sessions will be performed in clinic supervised by PT to assess LOP and form prior to performance at home c. Exercises: i. Weeks 6-12: Single leg squat to 45 deg knee flexion (holding weight as tolerated), single leg Romanian dead lift (holding weight a weight as tolerated), Bulgarian split squat (holding a weight as tolerated)
- Phase 4 (12+ weeks) a. BFR intervention will be discontinued at 12 weeks and participants will progress per standard protocol for the remainder of their rehabilitation course vi. Control Group
- Control group will follow the standard of care outlined in Appendix A. vii. Criteria for progression within the BFR specific exercise protocol
- Regardless of functional performance, patients will not be allowed to progress ahead of the time-based exercise prescription in the BFR protocol. However, if the treating therapist determines that the current week's exercise prescription is too difficult for the patient, subject may return to the prior week's exercise set until able to advance.
- Conditions
- Hip Injuries
- Being tested
- BFR
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFRDevice
BFR cuffs will be used at home during specified exercises in addition to SOC for post hip scope PT.
| Study group | Role | What they receive |
|---|---|---|
| BFR Group | Experimental | BFR cuffs will be used for specific exercises and added to the current SOC for post hip scope PT. Receives: Device: BFR |
| SOC Group | No intervention | Current SOC for post hip scope PT will be assigned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip extensor strength
- Strength of hip extensors via handheld dynamometry (HHD) and reported as a measure of limb symmetry index (LSI) comparing operative limb to non-operative limb. By 3 months post operatively, patients should be approaching 70% LSI in order to safely initiate impact activities such as jogging. Prior to discharge from therapy, patients should achieve at least 90% LSI per standard protocol.
Measured: 2 Years
Secondary outcomes (9)
additional hip musculature strength
- Strength of hip flexors, abductors and adductors via handheld dynamometry (HHD) and reported as a measure of limb symmetry index (LSI) comparing operative limb to non-operative limb. By 3 months post operatively, patients should be approaching 70% LSI in order to safely initiate impact activities such as jogging. Prior to discharge from therapy, patients should achieve at least 90% LSI per standard protocol.
Measured: 2 Years
single leg squat test
- Performance on a Repeated Single Leg Squat test to 45 deg knee flexion over the course of 90 seconds reported as a measure of LSI. Prior to initiation of impact activities such as jogging (usually around 3 months), patient should be approaching 70% LSI per standard protocol and 90% by time of discharge.
Measured: 2 Years
i-HOT
Range 0 (poor health) - 100 (good health); MCD = Δ13
Measured: 2 Years
LEFS
Range 0 (extreme difficulty) - 100 (extreme difficulty); MDIC = Δ 123
Measured: 2 Years
PROMIS pain
PROMIS Pain: Range 0 (low pain) - 100 (high pain); MDC = Δ 85.
Measured: 2 Years
Brief Resiliency Score
Range 1 (low resilience) - 5 (high resilience)
Measured: 2 Years
PROMIS physical function
PROMIS Physical Function: Range 0 (low function) - 100 (high function); MDC = Δ 85
Measured: 2 Years
range of motion (ROM)
MDC = Δ low (1-2.99) to normal (3-4.3) to high (4.31-5)
Measured: 2 Years
Tegner Activity Scale
Range 0 (disability because of knee problems) - 10 (national or international level soccer)
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start29 Apr 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip InjuriesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Genuario, MD, Principal investigator, University of Colorado SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165927
- Sponsor's protocol ID
- 21-4753
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2021
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methods in Post Operative Hip Arthroscopy Rehabilitation
- ClinicalTrials.gov ID
- NCT05165927
- Acronym / sponsor ID
- 21-4753
- Conditions
- Hip Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Dec 2021 (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.
The investigators plan to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following hip arthroscopy. BFR has shown to be great at helping the recovery process. SAGA is a well-known smart training technology company, and the investigators aim to partner with SAGA to use the BFR cuffs as the intervention method. The BFR cuff will be added to the current SOC for hip scope PT for the intervention group.
Detailed description
Study Design and Research Methods i. Timeline: Treatment Protocol duration 12 weeks per participant beginning post operative day 1 following hip arthroscopy. PRO's will be collected out to 2 years post-surgery and standard rehabilitation will follow the 12-week intervention period for both the control and experimental group. Study will be a 2-year timeline in total.
ii. Procedures: Patients will be randomized to control group, who will undergo Steadman Hawkins Clinic Denver's standard hip arthroscopy rehab protocol (see appendix) or to the intervention group, who will undergo standard rehab protocol with addition of BFR. Subjects will be randomized 1:1 for intervention vs. control and controlled for gender assigned at birth.
iii. Frequency of BFR Training: 6 days per week phase 1, 3 days per week phases 2 and 3 iv. Frequency of clinic visits PT: 1 day per week v. Intervention Group: The following exercises outlined are the specific exercises that will be performed in addition to SOC. Only these exercises will involve the use of the BFR cuff.
- Phase 1 (post operative weeks 1-3)
- Dosage: 80% limb occlusion pressure (LOP). 30x15x15x15 repetitions with 30 sec rests between sets. At least 1 min rest between exercises with occlusion OFF.
- Frequency: All 3 exercises performed at least 6 days per week. The first of these sessions will be performed in clinic supervised by PT to assess LOP and form prior to performance at home
- Exercises:
- Week 1: quadriceps set, gluteal set, hamstring set ii. Week 2: short arc quad, hook lying adduction/internal rotation isometric, hook lying abduction/external rotation isometric iii. Week 3: long arc quad, bridge, standing hamstring curl
- Phase 2 (weeks 4-6)
- Dosage: 80% LOP. 30x15x15x15 repetitions with 30 sec rests between sets. At least 1 min rest between exercises with occlusion OFF
- Frequency: All 3 resistive exercises performed at least 3 days per week. The first of these sessions will be performed in clinic supervised by PT to assess LOP and form prior to performance at home
- Exercises:
- Week 4: mini squat, prone hip extension over plinth, quadruped rock ii. Week 5: mid-range squat, modified single leg bridge foot on ball, heel slide strap assist iii. Week 6: step up, standing hip abduction, single leg bridge
- Phase 3 (weeks 6-12)
- Dosage: 80% LOP at 20-30% 1 RM.1 RM re-evaluated every 2 weeks to adjust resistance prescription. 30x15x15x15 repetitions with 30 sec rests between sets. At least 1 min rest between exercises with occlusion OFF b. Frequency: All 3 resistive exercises performed at least 3 days per week. The first of these sessions will be performed in clinic supervised by PT to assess LOP and form prior to performance at home c. Exercises: i. Weeks 6-12: Single leg squat to 45 deg knee flexion (holding weight as tolerated), single leg Romanian dead lift (holding weight a weight as tolerated), Bulgarian split squat (holding a weight as tolerated)
- Phase 4 (12+ weeks) a. BFR intervention will be discontinued at 12 weeks and participants will progress per standard protocol for the remainder of their rehabilitation course vi. Control Group
- Control group will follow the standard of care outlined in Appendix A. vii. Criteria for progression within the BFR specific exercise protocol
- Regardless of functional performance, patients will not be allowed to progress ahead of the time-based exercise prescription in the BFR protocol. However, if the treating therapist determines that the current week's exercise prescription is too difficult for the patient, subject may return to the prior week's exercise set until able to advance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR Group | Experimental | Device: BFRBFR cuffs will be used for specific exercises and added to the current SOC for post hip scope PT. |
| SOC Group | No intervention | –Current SOC for post hip scope PT will be assigned. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with labral tears, femoroacetabular impingement syndrome, loose bodies, ligamentum teres tears, and related intra-articular pathology to be treated with hip arthroscopy. Patients must also have access to a smartphone device in order to utilize the SAGA BFR application for use. The application is free to use.
Key exclusion criteria (10 listed)
- bilateral hip surgeries to be performed within 12 weeks of each other, concomitant Peri-acetabular osteotomy, soft tissue repairs (hamstring, glute repairs), clinically diagnosed hip dysplasia, and the following BFR contraindications:
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 |
|---|---|---|
| BFRBFR cuffs will be used at home during specified exercises in addition to SOC for post hip scope PT. | Device | BFR Group |
Primary outcome
Hip extensor strength
Time frame: 2 Years
1. Strength of hip extensors via handheld dynamometry (HHD) and reported as a measure of limb symmetry index (LSI) comparing operative limb to non-operative limb. By 3 months post operatively, patients should be approaching 70% LSI in order to safely initiate impact activities such as jogging. Prior to discharge from therapy, patients should achieve at least 90% LSI per standard protocol.
9 secondary outcomes
additional hip musculature strength
Time frame: 2 Years
single leg squat test
Time frame: 2 Years
i-HOT
Time frame: 2 Years
LEFS
Time frame: 2 Years
PROMIS pain
Time frame: 2 Years
Brief Resiliency Score
Time frame: 2 Years
PROMIS physical function
Time frame: 2 Years
range of motion (ROM)
Time frame: 2 Years
Tegner Activity Scale
Time frame: 2 Years
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 11 Dec 2024.
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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.
James Genuario, MD principal investigator
University of Colorado SOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR in people with Hip Injuries, run by University of Colorado, Denver 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 1 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 11 Dec 2024. 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. 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 Lauren M Heylmun, BS (7205169823, lauren.heylmun@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip extensor strength (time frame: 2 Years). 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 11 Dec 2024.