Comparison of Methods in Post Operative Hip Arthroscopy Rehabilitation

NCT05165927 | Recruiting FDA Device

• 1 other identifier: 21-4753
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Injuries

Outcome Measures

Primary Outcomes (1)

• 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.

  2 Years

Secondary Outcomes (9)

• additional hip musculature strength

  2 Years

• single leg squat test

  2 Years

• i-HOT

  2 Years

• LEFS

  2 Years

• PROMIS pain

  2 Years

Study Arms (2)

BFR Group

EXPERIMENTAL

BFR cuffs will be used for specific exercises and added to the current SOC for post hip scope PT.

Device: BFR

SOC Group

NO INTERVENTION

Current SOC for post hip scope PT will be assigned.

Interventions

BFR DEVICE

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

BFR Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

UCHealth Steadman Hawkins Clinic Denver

Englewood, Colorado, 80012, United States

RECRUITING

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• James Genuario, MD

  University of Colorado SOM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren M Heylmun, BS

CONTACT

7205169823; lauren.heylmun@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: ACT's that collect data during visits will be blinded to what group the subject is in to prevent bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 21, 2021
• Study Start: April 29, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

US (1)