Blood Flow Restriction Following Hip Arthroscopy

Study Purpose

This study will be a prospective randomized, double-blinded, placebo-controlled trial of patients undergoing primary hip arthroscopy for FAIS and/or labral pathology. All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. Follow-up will take place at 1-month, 3-months, 6-months, and 1-year.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 40 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Adult patients 18-40.
  • - English-speaking.
  • - Clinical and radiographic examination (MRI) consistent FAIS and/or labral pathology, and are schedule for primary hip arthroscopy.
  • - Written and informed consent for study participation.

Exclusion Criteria:

  • - Patients younger than 18 or older than 40 years of age.
  • - Non-native English speaker.
  • - Revision surgery or prior history of ipsilateral hip or knee surgery.
  • - Inability to comply with the proposed follow-up clinic visits.
  • - Patients lacking decisional capacity.
  • - Patients with a history of deep vein thrombosis, pulmonary embolism, or known clotting disorder or hypercoagulable state.
  • - Pregnant or breast-feeding women.
Pregnancy as determined by a positive pregnancy test prior to procedure. Females of childbearing potential must agree to use an acceptable birth control method during study participation.
  • - Worker's compensation patients.
  • - Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study.
- Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04113759
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rush University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jorge Chahla, MD PhD
Principal Investigator Affiliation Rush University Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Labral Tear, Glenoid, Femoral Acetabular Impingement
Additional Details

The investigators propose using standardized strength testing, serial quadriceps measurements, and MRI to assess the efficacy of BFR training in increasing muscle hypertrophy following hip arthroscopy. Investigators will perform a randomized double-blinded placebo-controlled controlled trial of patients undergoing primary hip arthroscopy. Quadriceps strength will be measured with dynamometers at 3, 6, and 12 month time points, with Biodex strength testing at 6 and 12 months, postoperatively. Additionally, standardized circumferential leg measurements to assess quadriceps hypertrophy will be performed at 1, 3, 6 and 12-month time points. Patients will also undergo a hip MRI at 6 months postoperatively to quantify muscle size and appearance about the hip joint. Patient reported outcomes including standard outcomes measures at 3, 6, and 12 months and return to work/sport data will also be collected at standard time points. Patients will also be followed longitudinally for rates of reinjury, return to work, and return to sport. This study will evaluate the efficacy of BFR therapy in the postoperative period of primary hip arthroscopy to improve muscle hypertrophy during the short-term rehabilitation period. This will be directly measured by strength testing with dynamometers and Biodex testing. Other metrics will include standard validated patient reported outcomes at 3, 6 and 12 month time points including hip disability and osteoarthritis outcome score (HOOS), Harris Hip score (HHS), visual analog scale (VAS) for pain, international hip outcome tool (iHOT-12), and Hip outcome score (HOS), and return to sport questionnaires. Standardized serial circumferential thigh measurements will also be recorded at each visit, in additional to a one time MRI at 6 months postoperatively.

Arms & Interventions

Arms

Placebo Comparator: Control Group

The control group will receive sham BFR, in which a non-occlusive pressure is applied with the cuff. The exercises performed will be identical to the BFR group.

Experimental: BFR Postoperative Rehabilitation

The experimental group will receive BFR postoperative rehabilitation, which will involve performing a series of blood flow restriction exercises identical to the control group.

Interventions

Behavioral: - Blood Flow Restriction Rehabilitative Therapy

BFR cuffs placed at the proximal thigh, just inferior to the greater trochanter. Inflation time not to exceed 20 minutes. One BFR session per treatment. BFR exercise dosage: 4 sets of the following repetitions 30, 15, 15, 15, 30 second rest between sets, 1 min rest between exercises. Progress exercise if pain <2/10 on VAS and RPE <5 on 0-10 scale. (Heerey et al), and no break down in form.

Behavioral: - Sham BFR Rehabilitative Therapy

The schedule, type of exercises, repetition ranges, and other physical therapy interventions will be the same as the BFR experimental group - however a non-occlusive pressure will be applied with the cuff in the control group.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rush University Medical Center, Chicago, Illinois

Status

Recruiting

Address

Rush University Medical Center

Chicago, Illinois, 60612

Site Contact

Carla M Edwards, PhD

[email protected]

312-563-5735