NCT04113759

Blood Flow Restriction Following Hip Arthroscopy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Labral Tear, Glenoid
• Femoral Acetabular Impingement

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2027-11-01
• Completion: 2028-01-01
• First posted: 2019-10-03
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States