Clinical trial NCT04113759: Blood Flow Restriction Following Hip Arthroscopy
Official title: Postoperative Blood Flow Restriction Training Following Hip Arthroscopy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labral Tear, Glenoid
Femoral Acetabular Impingement
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Quadriceps Strength
timeFrame: 3 month time point
measure: Quadriceps Strength
timeFrame: 6 month time point
measure: Quadriceps Strength
timeFrame: 12 month time point
measure: Biodex strength testing
timeFrame: 6 month time point
measure: Biodex strength testing
timeFrame: 12 month time point
measure: Standardized circumferential leg meaurements
timeFrame: 1 month time point
measure: Standardized circumferential leg meaurements
timeFrame: 3 month time point
measure: Standardized circumferential leg meaurements
timeFrame: 6 month time point
measure: Standardized circumferential leg meaurements
timeFrame: 12 month time point
measure: Muscle size and appearance about the hip joint
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Hip Disability and Osteoarthritis Outcome Score
timeFrame: 3 month time point
measure: Hip Disability and Osteoarthritis Outcome Score
timeFrame: 6 month time point
measure: Hip Disability and Osteoarthritis Outcome Score
timeFrame: 12 month time point
measure: Harris Hip Score
timeFrame: 3 month time point
measure: Harris Hip Score
timeFrame: 6 month time point
measure: Harris Hip Score
timeFrame: 12 month time point
measure: Visual Analog Scale for pain
timeFrame: 3 month time point
measure: Visual Analog Scale for pain
timeFrame: 6 month time point
measure: Visual Analog Scale for pain
timeFrame: 12 month time point
measure: International hip outcome tool
timeFrame: 3 month time point
measure: International hip outcome tool
timeFrame: 6 month time point
measure: International hip outcome tool
timeFrame: 12 month time point
measure: Hip Outcome Score
timeFrame: 3 month time point
measure: Hip Outcome Score
timeFrame: 6 month time point
measure: Hip Outcome Score
timeFrame: 12 month time point
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Jorge Chahla, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: