BFR After Biceps Tendon Repair and MPFLR

Study Overview
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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.

Official Title
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Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Biceps Tendon Rupture and Medial Patellofemoral Ligament Reconstruction

Conditions
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Patellofemoral Joint Dislocation, Bicep Tendon Rupture

Intervention / Treatment
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* Other: Blood Flow Restriction (BFR) Therapy
* Other: Physical Therapy


Participation Criteria
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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unable to tolerate BFR treatment, unable to complete physical therapy, peripheral vascular disease Subjects will be withdrawn from the study if they are unable to tolerate the BFR therapy. Additionally if they suffer from any complications of the therapy they will be withdrawn immediately.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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional rehabilitation plus blood flow restriction (BFR) therapy<br>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<br>* 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.<br>|
| Active Comparator: Conventional rehabilitation<br>Following standard of care surgery, subjects will immediately be started in standard of care physical therapy. | Other: Physical Therapy<br>* Standard of care physical therapy consisting of a structured program progressing from range of motion to strength training and then functional tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in strength | Measured by a dynamometer | Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in range of motion | Measured by a goniometer reported in degrees | Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bicep tendon repair, medial patellofemoral ligament reconstruction