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BFR Therapy for Hip Surgery Rehabilitation

N/A

Recruiting

Led By James Genuario, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with labral tears, femoroacetabular impingement syndrome, loose bodies, ligamentum teres tears, and related intra-articular pathology to be treated with hip arthroscopy

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will investigate whether blood flow restriction therapy can help with post-operative rehabilitation following hip arthroscopy. The cuffs will be added to the current SOC for hip scope PT for the intervention group.

Who is the study for?

This trial is for individuals with hip injuries like labral tears or femoroacetabular impingement, who are undergoing hip arthroscopy. Participants need to have a smartphone to use the free SAGA BFR app. It's not for those with untreated low blood pressure, recent severe muscle injury, planned bilateral hip surgeries close together, certain hip conditions, clotting disorders, pregnancy up to 6 months post-partum, or untreated high blood pressure.Check my eligibility

What is being tested?

The study tests the effectiveness of Blood Flow Restriction (BFR) therapy during rehabilitation after hip surgery. The intervention group will use BFR cuffs provided by SAGA alongside standard physical therapy practices and track progress using an app.See study design

What are the potential side effects?

While specific side effects of BFR aren't detailed here, generally it can cause discomfort at the cuff site and temporary changes in skin coloration due to restricted blood flow. There may be risks associated with improper application or pre-existing health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a hip condition that requires surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hip extensor strength

Secondary outcome measures

Brief Resiliency Score

LEFS

PROMIS pain

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BFR GroupExperimental Treatment1 Intervention

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

Group II: SOC GroupActive Control1 Intervention

Current SOC for post hip scope PT will be assigned.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BFR

2019

N/A

~30

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,734 Previous Clinical Trials

2,148,763 Total Patients Enrolled

James Genuario, MDPrincipal InvestigatorUniversity of Colorado SOM

3 Previous Clinical Trials

89 Total Patients Enrolled

Media Library

BFR Clinical Trial Eligibility Overview. Trial Name: NCT05165927 — N/A

Hip Injury Research Study Groups: BFR Group, SOC Group

Hip Injury Clinical Trial 2023: BFR Highlights & Side Effects. Trial Name: NCT05165927 — N/A

BFR 2023 Treatment Timeline for Medical Study. Trial Name: NCT05165927 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this research encompass individuals of a young age?

"This medical trial has outlined eligibility requirements of being between the ages of 14 and 70. There are additional studies tailored to those under 18 and over 65, both with a total participant count of 7 and 2 respectively."

Answered by AI

Is this experiment actively recruiting participants currently?

"That is accurate. According to clinicaltrials.gov, this research project – that was initially posted on April 29th 2022 – seeks participants and has recently been updated . The goal is to enroll 120 patients from a single location."

Answered by AI

How can I become enrolled in this experiment?

"This medical trial requires that prospective participants are aged between 14 and 70 years old, with hip injuries. Altogether, 120 individuals will be enrolled in the study."

Answered by AI

How large is the patient cohort enrolled in this experiment?

"Affirmative. Information hosted on clinicaltrials.gov implies that this research endeavour, first published on April 29th 2022, is currently recruiting test subjects. In order to meet their quota of 120 patients, they need volunteers from 1 distinct medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Methods in Post Operative Hip Arthroscopy Rehabilitation

2022. "Comparison of Methods in Post Operative Hip Arthroscopy Rehabilitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05165927.