Postoperative Blood Flow Restriction Training Following Hip Arthroscopy: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Labral Tear, Glenoid
- Sponsor
- Rush University Medical Center
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Muscle size and appearance about the hip joint
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Muscle size and appearance about the hip joint
Time Frame: 6 months postoperatively
To be assessed via hip MRI postoperatively
Biodex strength testing
Time Frame: 12 month time point
Isokinetic strength testing
Quadriceps Strength
Time Frame: 12 month time point
Will be measured with dynamometer
Standardized circumferential leg meaurements
Time Frame: 12 month time point
To assesss quadricep hypertrophy
Secondary Outcomes
- Hip Outcome Score(12 month time point)
- Visual Analog Scale for pain(12 month time point)
- Hip Disability and Osteoarthritis Outcome Score(12 month time point)
- Harris Hip Score(12 month time point)
- International hip outcome tool(12 month time point)