BFR After Biceps Tendon Repair and MPFLR

NCT05375071 | Withdrawn

• 1 other identifier: 21-006791
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Joint Dislocation; Bicep Tendon Rupture

Keywords

Bicep tendon repair; medial patellofemoral ligament reconstruction

Outcome Measures

Primary Outcomes (1)

• Change in strength

  Measured by a dynamometer

  Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months

Secondary Outcomes (1)

• Change in range of motion

  Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months

Study Arms (2)

Conventional rehabilitation plus blood flow restriction (BFR) therapy

EXPERIMENTAL

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.

Other: Blood Flow Restriction (BFR) Therapy

Conventional rehabilitation

ACTIVE COMPARATOR

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

Other: Physical Therapy

Interventions

Blood Flow Restriction (BFR) Therapy 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 plus blood flow restriction (BFR) therapy

Physical Therapy OTHER

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

Conventional rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55902, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Patellar Dislocation

Interventions

Therapeutics; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Knee Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation

Study Officials

• Kelechi Okoroha, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: July 29, 2025
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)