Comparison of Methods in Post Operative Hip Arthroscopy Rehabilitation
Primary Purpose
Hip Injuries
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BFR
Sponsored by
About this trial
This is an interventional treatment trial for Hip Injuries
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
- Pregnant or up to 6 months post-partum
- Untreated Hypertension
- Untreated Hypotension
- Rhabdomyolysis or recent traumatic injury
Sites / Locations
- UCHealth Steadman Hawkins Clinic DenverRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
BFR Group
SOC Group
Arm Description
BFR cuffs will be used for specific exercises and added to the current SOC for post hip scope PT.
Current SOC for post hip scope PT will be assigned.
Outcomes
Primary Outcome Measures
Hip extensor strength
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.
Secondary Outcome Measures
additional hip musculature strength
1. 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.
single leg squat test
2. 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.
i-HOT
Range 0 (poor health) - 100 (good health); MCD = Δ13
LEFS
Range 0 (extreme difficulty) - 100 (extreme difficulty); MDIC = Δ 123
PROMIS pain
PROMIS Pain: Range 0 (low pain) - 100 (high pain); MDC = Δ 85.
Brief Resiliency Score
Range 1 (low resilience) - 5 (high resilience)
PROMIS physical function
PROMIS Physical Function: Range 0 (low function) - 100 (high function); MDC = Δ 85
range of motion (ROM)
MDC = Δ low (1-2.99) to normal (3-4.3) to high (4.31-5)
Tegner Activity Scale
Range 0 (disability because of knee problems) - 10 (national or international level soccer)
Full Information
NCT ID
NCT05165927
First Posted
December 3, 2021
Last Updated
July 6, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT05165927
Brief Title
Comparison of Methods in Post Operative Hip Arthroscopy Rehabilitation
Official Title
Comparison of Methods in Post Operative Hip Arthroscopy Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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:
i. 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:
i. 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)
a. 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
1. Control group will follow the standard of care outlined in Appendix A. vii. Criteria for progression within the BFR specific exercise protocol
1. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
ACT's that collect data during visits will be blinded to what group the subject is in to prevent bias.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BFR Group
Arm Type
Experimental
Arm Description
BFR cuffs will be used for specific exercises and added to the current SOC for post hip scope PT.
Arm Title
SOC Group
Arm Type
No Intervention
Arm Description
Current SOC for post hip scope PT will be assigned.
Intervention Type
Device
Intervention Name(s)
BFR
Intervention Description
BFR cuffs will be used at home during specified exercises in addition to SOC for post hip scope PT.
Primary Outcome Measure Information:
Title
Hip extensor strength
Description
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.
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
additional hip musculature strength
Description
1. 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.
Time Frame
2 Years
Title
single leg squat test
Description
2. 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.
Time Frame
2 Years
Title
i-HOT
Description
Range 0 (poor health) - 100 (good health); MCD = Δ13
Time Frame
2 Years
Title
LEFS
Description
Range 0 (extreme difficulty) - 100 (extreme difficulty); MDIC = Δ 123
Time Frame
2 Years
Title
PROMIS pain
Description
PROMIS Pain: Range 0 (low pain) - 100 (high pain); MDC = Δ 85.
Time Frame
2 Years
Title
Brief Resiliency Score
Description
Range 1 (low resilience) - 5 (high resilience)
Time Frame
2 Years
Title
PROMIS physical function
Description
PROMIS Physical Function: Range 0 (low function) - 100 (high function); MDC = Δ 85
Time Frame
2 Years
Title
range of motion (ROM)
Description
MDC = Δ low (1-2.99) to normal (3-4.3) to high (4.31-5)
Time Frame
2 Years
Title
Tegner Activity Scale
Description
Range 0 (disability because of knee problems) - 10 (national or international level soccer)
Time Frame
2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Pregnant or up to 6 months post-partum
Untreated Hypertension
Untreated Hypotension
Rhabdomyolysis or recent traumatic injury
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren M Heylmun, BS
Phone
7205169823
Email
lauren.heylmun@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Genuario, MD
Organizational Affiliation
University of Colorado SOM
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCHealth Steadman Hawkins Clinic Denver
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Heylmun, BS
Phone
720-516-9823
Email
lauren.heylmun@cuanschutz.edu
12. IPD Sharing Statement
Learn more about this trial
Comparison of Methods in Post Operative Hip Arthroscopy Rehabilitation
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