BFR After Biceps Tendon Repair and MPFLR

Not Applicable

Not yet recruiting

• Conditions: Bicep Tendon Rupture; Patellofemoral Joint Dislocation
• Interventions: Other: Physical Therapy; Other: Blood Flow Restriction (BFR) Therapy

• Registration Number: NCT05375071
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Study Start: 2024-12
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 68

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

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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• Subjects will be withdrawn from the study if they are unable to tolerate the BFR therapy. Additionally if they suffer from any complications of the therapy they will be withdrawn immediately.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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conventional rehabilitation	Physical Therapy	Following standard of care surgery, subjects will immediately be started in standard of care physical therapy.
Conventional rehabilitation plus blood flow restriction (BFR) therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in strength	Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months	Measured by a dynamometer

Secondary Outcome Measures

Name	Time	Method
Change in range of motion	Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months	Measured by a goniometer reported in degrees

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States