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WithdrawnNCT05375071Updated Sep 29, 2025

BFR After Biceps Tendon Repair and MPFLR

An interventional study of Blood Flow Restriction (BFR) Therapy and Physical Therapy in Patellofemoral Joint Dislocation and Bicep Tendon Rupture, sponsored by Mayo Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
PI left Mayo Clinic, study never started
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Patellofemoral Joint Dislocation
  • Bicep Tendon Rupture

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Keywords

  • Bicep tendon repair
  • medial patellofemoral ligament reconstruction
03

In context

Patellar Dislocation

41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.

Browse Patellar Dislocation studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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  • Subjects will be withdrawn from the study if they are unable to tolerate the BFR therapy.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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    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.

    Other: Blood Flow Restriction (BFR) Therapy

  • Active comparator
    Conventional rehabilitation

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

    Other: Physical Therapy

Interventions

  • OtherBlood 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.

  • OtherPhysical Therapy

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

06

What researchers measure

Primary outcomes

  1. Change in strength

    Measured by a dynamometer

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

Secondary outcomes

  1. Change in range of motion

    Measured by a goniometer reported in degrees

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

07

Study locations

1 site
  • Mayo Clinic Rochester
    Rochester, Minnesota 55902, United States
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2025 to primary completion in Jul 2025, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2022
First posted
May 16, 2022
StartActual
Jul 29, 2025
Primary completionActual
Jul 29, 2025
CompletionActual
Jul 29, 2025
Last update
Sep 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05375071
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
May 16, 2022
Start date
Jul 29, 2025
Primary completion
Jul 29, 2025
Completion
Jul 29, 2025
Last update
Sep 29, 2025

Study contacts

Kelechi Okoroha, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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