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Recruiting NCT04113759

Blood Flow Restriction Following Hip Arthroscopy

No phase Interventional Labral Tear, Glenoid Femoral Acetabular Impingement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood Flow Restriction Rehabilitative Therapy, Sham BFR Rehabilitative Therapy.
Who it may be relevant to
Registry conditions: Labral Tear, Glenoid, Femoral Acetabular Impingement. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Postoperative Blood Flow Restriction Training Following Hip Arthroscopy: A Randomized Clinical Trial

Overview

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.

Detailed description

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.

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.

Primary outcome measures

  • Quadriceps Strength [Time frame: 3 month time point]
  • Quadriceps Strength [Time frame: 6 month time point]
  • Quadriceps Strength [Time frame: 12 month time point]
  • Biodex strength testing [Time frame: 6 month time point]
  • Biodex strength testing [Time frame: 12 month time point]
  • Standardized circumferential leg meaurements [Time frame: 1 month time point]
  • Standardized circumferential leg meaurements [Time frame: 3 month time point]
  • Standardized circumferential leg meaurements [Time frame: 6 month time point]
  • Standardized circumferential leg meaurements [Time frame: 12 month time point]
  • Muscle size and appearance about the hip joint [Time frame: 6 months postoperatively]
Secondary outcome measures (12)
  • Hip Disability and Osteoarthritis Outcome Score [Time frame: 3 month time point]
  • Hip Disability and Osteoarthritis Outcome Score [Time frame: 6 month time point]
  • Hip Disability and Osteoarthritis Outcome Score [Time frame: 12 month time point]
  • Harris Hip Score [Time frame: 3 month time point]
  • Harris Hip Score [Time frame: 6 month time point]
  • Harris Hip Score [Time frame: 12 month time point]
  • Visual Analog Scale for pain [Time frame: 3 month time point]
  • Visual Analog Scale for pain [Time frame: 6 month time point]
  • Visual Analog Scale for pain [Time frame: 12 month time point]
  • International hip outcome tool [Time frame: 3 month time point]
  • International hip outcome tool [Time frame: 6 month time point]
  • International hip outcome tool [Time frame: 12 month time point]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Rush University Medical Center — Chicago

Identifiers

NCT: NCT04113759 · 19093005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗