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Clinical Trials/NCT04503421
NCT04503421
Completed
Not Applicable

Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal: A Prospective Randomized Control Trial

Henry Ford Health System1 site in 1 country64 target enrollmentAugust 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bicep Tendon Rupture
Sponsor
Henry Ford Health System
Enrollment
64
Locations
1
Primary Endpoint
Strength
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The goal of this investigation is to determine if using BFR during postoperative therapy would lead to increased and expedited strength gains. Additionally, the investigators would like to determine if BFR is beneficial in preventing muscle atrophy and fatty infiltration in the setting of bicep tendon tears, due to the altered tension-length relationship following surgery. The study will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding distal biceps tear and surgical repair

Registry
clinicaltrials.gov
Start Date
August 15, 2020
End Date
September 15, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Charles S Day

Orthopedic Surgeon

Henry Ford Health System

Eligibility Criteria

Inclusion Criteria

  • Age 18-80
  • Undergoing distal biceps tendon repair

Exclusion Criteria

  • Revision Biceps tendon repair,
  • Irrepairable tendon injury,
  • Biceps repairs with biologic augmentation,
  • Patients with concomitant neurovascular injury,
  • Inability to tolerate BFR treatment,
  • Unable to complete full course of physical therapy,
  • Peripheral vascular disease,
  • History of Venous thromboembolism (VTE)

Outcomes

Primary Outcomes

Strength

Time Frame: 6 months post-operatively

measured via dynamometer (pounds)

Secondary Outcomes

  • Patient reported outcome scores(6 months post-operatively)
  • Range of Motion(6 months post-operatively)
  • Perceived Pain(6 months post-operatively)

Study Sites (1)

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