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BFR After Biceps Tendon Repair and MPFLR

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Mayo Clinic

Status

Withdrawn

Conditions

Bicep Tendon Rupture
Patellofemoral Joint Dislocation

Treatments

Other: Blood Flow Restriction (BFR) Therapy
Other: Physical Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05375071
21-006791

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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  • Subjects will be withdrawn from the study if they are unable to tolerate the BFR therapy. Additionally if they suffer from any complications of the therapy they will be withdrawn immediately.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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Conventional rehabilitation plus blood flow restriction (BFR) therapy
Experimental group
Description:
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.
Treatment:
Other: Blood Flow Restriction (BFR) Therapy
Conventional rehabilitation
Active Comparator group
Description:
Following standard of care surgery, subjects will immediately be started in standard of care physical therapy.
Treatment:
Other: Physical Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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