Recruiting

Rehabilitation Methods

Sponsor:

University of Colorado, Denver

Code:

NCT05165927

Conditions

Hip Injuries

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

BFR

Study Details

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

Study ID

NCT05165927

Start date

Apr 29, 2022

Status verified date

Dec, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BFR Group

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

no intervention: SOC Group

Current SOC for post hip scope PT will be assigned.

Interventions

BFR

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

Primary outcome measure

  • Hip extensor strength [ Time Frame: 2 Years ]

Central Contacts and Locations

Central contacts

Lauren M Heylmun, BS

7205169823lauren.heylmun@cuanschutz.edu

Locations

UCHealth Steadman Hawkins Clinic Denver

Recruiting

Englewood, Colorado, United States, 80012

Contacts

Lauren Heylmun, BS

720-516-9823lauren.heylmun@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Dec 11, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-12-11.