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NCT Number: NCT05165927

Comparison of Methods in Post Operative Hip Arthroscopy Rehabilitation

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCHealth Steadman Hawkins Clinic Denver

Englewood, Colorado, 80012, United States

Location status: Recruiting

Location contact

Lauren Heylmun, BS

CONTACT

[email protected]

720-516-9823

About this study

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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BFR

Device

BFR cuffs will be used at home during specified exercises in addition to SOC for post hip scope PT.

Primary outcomes

  1. Hip extensor strength

    Time frame: 2 Years

    • 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 outcomes

  1. additional hip musculature strength

    Time frame: 2 Years

    • 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.
  2. single leg squat test

    Time frame: 2 Years

    • 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.
  3. i-HOT

    Time frame: 2 Years

    Range 0 (poor health) - 100 (good health); MCD = Δ13

  4. LEFS

    Time frame: 2 Years

    Range 0 (extreme difficulty) - 100 (extreme difficulty); MDIC = Δ 123

  5. PROMIS pain

    Time frame: 2 Years

    PROMIS Pain: Range 0 (low pain) - 100 (high pain); MDC = Δ 85.

  6. Brief Resiliency Score

    Time frame: 2 Years

    Range 1 (low resilience) - 5 (high resilience)

  7. PROMIS physical function

    Time frame: 2 Years

    PROMIS Physical Function: Range 0 (low function) - 100 (high function); MDC = Δ 85

  8. range of motion (ROM)

    Time frame: 2 Years

    MDC = Δ low (1-2.99) to normal (3-4.3) to high (4.31-5)

  9. Tegner Activity Scale

    Time frame: 2 Years

    Range 0 (disability because of knee problems) - 10 (national or international level soccer)

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren M Heylmun, BS

CONTACT

[email protected]

7205169823

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2021
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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