Blood Flow Restriction Following Hip Arthroscopy

Labral Tear, Glenoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04113759
• Other study ID #: 19093005
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: January 2026

Study information

• Verified date: December 2023
• Source: Rush University Medical Center
• Contact: Carla M. Edwards, PhD
• Phone: 312-563-5735
• Email: carla_edwards[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: January 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoral Acetabular Impingement
• Labral Tear, Glenoid
• Rotator Cuff Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps Strength	Will be measured with dynamometer	3 month time point
Primary	Quadriceps Strength	Will be measured with dynamometer	6 month time point
Primary	Quadriceps Strength	Will be measured with dynamometer	12 month time point
Primary	Biodex strength testing	Isokinetic strength testing	6 month time point
Primary	Biodex strength testing	Isokinetic strength testing	12 month time point
Primary	Standardized circumferential leg meaurements	To assesss quadricep hypertrophy	1 month time point
Primary	Standardized circumferential leg meaurements	To assesss quadricep hypertrophy	3 month time point
Primary	Standardized circumferential leg meaurements	To assesss quadricep hypertrophy	6 month time point
Primary	Standardized circumferential leg meaurements	To assesss quadricep hypertrophy	12 month time point
Primary	Muscle size and appearance about the hip joint	To be assessed via hip MRI postoperatively	6 months postoperatively
Secondary	Hip Disability and Osteoarthritis Outcome Score	Used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process.	3 month time point
Secondary	Hip Disability and Osteoarthritis Outcome Score	Used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process.	6 month time point
Secondary	Hip Disability and Osteoarthritis Outcome Score	Used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process.	12 month time point
Secondary	Harris Hip Score	Gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.	3 month time point
Secondary	Harris Hip Score	Gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.	6 month time point
Secondary	Harris Hip Score	Gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.	12 month time point
Secondary	Visual Analog Scale for pain	A 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."	3 month time point
Secondary	Visual Analog Scale for pain	A 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."	6 month time point
Secondary	Visual Analog Scale for pain	A 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."	12 month time point
Secondary	International hip outcome tool	Comprised of 33 questions relating to: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns	3 month time point
Secondary	International hip outcome tool	Comprised of 33 questions relating to: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns	6 month time point
Secondary	International hip outcome tool	Comprised of 33 questions relating to: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns	12 month time point
Secondary	Hip Outcome Score	A self-administered questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items.	3 month time point
Secondary	Hip Outcome Score	A self-administered questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items.	6 month time point
Secondary	Hip Outcome Score	A self-administered questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items.	12 month time point