NCT05375071WithdrawnNot Applicable
Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Biceps Tendon Rupture and Medial Patellofemoral Ligament Reconstruction
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Mayo Clinic
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Change in strength
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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- •Subjects will be withdrawn from the study if they are unable to tolerate the BFR therapy. Additionally if they suffer from any complications of the therapy they will be withdrawn immediately.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.
Arms & Interventions
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.
Intervention: Blood Flow Restriction (BFR) Therapy (Other)
Conventional rehabilitation
Active Comparator
Following standard of care surgery, subjects will immediately be started in standard of care physical therapy.
Intervention: Physical Therapy (Other)
Outcomes
Primary Outcomes
Change in strength
Time Frame: Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months
Measured by a dynamometer
Secondary Outcomes
- Change in range of motion(Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months)
Investigators
Study Sites (1)
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