BFR After Biceps Tendon Repair and MPFLR

NCT ID: NCT05375071

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-29

Study Completion Date

2025-07-29

Brief Summary

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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.

Detailed Description

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Conditions

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Patellofemoral Joint Dislocation Bicep Tendon Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Conventional rehabilitation plus blood flow restriction (BFR) therapy

Following standard of care surgery, subjects will immediately be started in standard of care physical therapy. Additionally, a BFR Cuff will be applied during physical therapy.

Group Type EXPERIMENTAL

Blood Flow Restriction (BFR) Therapy

Intervention Type OTHER

BFR Cuff will be applied to the most proximal portion of the affected arm or leg, immediately before performing exercises during physical therapy. The cuff will remain on for the entire time while an exercise is performed and will be removed in between exercises while the subject rests.

Conventional rehabilitation

Following standard of care surgery, subjects will immediately be started in standard of care physical therapy.

Group Type ACTIVE_COMPARATOR

Physical Therapy

Intervention Type OTHER

Standard of care physical therapy consisting of a structured program progressing from range of motion to strength training and then functional tests

Interventions

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Blood Flow Restriction (BFR) Therapy

BFR Cuff will be applied to the most proximal portion of the affected arm or leg, immediately before performing exercises during physical therapy. The cuff will remain on for the entire time while an exercise is performed and will be removed in between exercises while the subject rests.

Intervention Type OTHER

Physical Therapy

Standard of care physical therapy consisting of a structured program progressing from range of motion to strength training and then functional tests

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kelechi Okoroha, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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21-006791

Identifier Type: -

Identifier Source: org_study_id

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