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Clinical Trials/NCT05375071
NCT05375071
Withdrawn
Not Applicable

Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Biceps Tendon Rupture and Medial Patellofemoral Ligament Reconstruction

Mayo Clinic1 site in 1 country68 target enrollmentJuly 29, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patellofemoral Joint Dislocation
Sponsor
Mayo Clinic
Enrollment
68
Locations
1
Primary Endpoint
Change in strength
Status
Withdrawn
Last Updated
7 months ago

Overview

Brief Summary

The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy after distal biceps tendon repair or medial patellofemoral ligament reconstruction (MPFLR) following a tear.

Registry
clinicaltrials.gov
Start Date
July 29, 2025
End Date
July 29, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Subjects will be recruited from our ambulatory sports medicine clinics. We will include patients aged 18-80 who suffered a biceps tear and are undergoing biceps repair or MPFLR

Exclusion Criteria

  • Subjects will be excluded if they are undergoing revision biceps repair or revision MPFLR, history of DVT, neurovascular injury, unable to tolerate BFR treatment, unable to complete physical therapy, peripheral vascular disease
  • Subjects will be withdrawn from the study if they are unable to tolerate the BFR therapy. Additionally if they suffer from any complications of the therapy they will be withdrawn immediately. This will be facilitated by describing the reasons for withdrawal to the patient prior to initiating the study and ask patients and other providers to inform the investigators if there are any issues or concerns.

Outcomes

Primary Outcomes

Change in strength

Time Frame: Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months

Measured by a dynamometer

Secondary Outcomes

  • Change in range of motion(Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months)

Study Sites (1)

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