Blood Flow Restriction Following Hip Arthroscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorRush University Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Blood Flow Restriction Rehabilitative Therapy
BehavioralBFR 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
BehavioralThe 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.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Control GroupPlacebo comparator 1 intervention
Group B: BFR Postoperative RehabilitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Quadriceps Strength
Will be measured with dynamometer
Time frame
3 month time point2
Quadriceps Strength
Will be measured with dynamometer
Time frame
6 month time point3
Quadriceps Strength
Will be measured with dynamometer
Time frame
12 month time point4
Biodex strength testing
Isokinetic strength testing
Time frame
6 month time pointSecondary outcomes
1
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.
Time frame
3 month time point2
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.
Time frame
6 month time point3
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.
Time frame
12 month time point4
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.
Time frame
3 month time pointSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov