Back to resultsBFR After Biceps Tendon Repair and MPFLR
Primary Purpose
Patellofemoral Joint Dislocation, Bicep Tendon Rupture
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction (BFR) Therapy
Physical Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Patellofemoral Joint Dislocation focused on measuring Bicep tendon repair, medial patellofemoral ligament reconstruction
Eligibility Criteria
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- Subjects will be withdrawn from the study if they are unable to tolerate the BFR therapy. Additionally if they suffer from any complications of the therapy they will be withdrawn immediately.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.
Sites / Locations
- Mayo Clinic Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Conventional rehabilitation plus blood flow restriction (BFR) therapy
Conventional rehabilitation
Arm 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.
Following standard of care surgery, subjects will immediately be started in standard of care physical therapy.
Outcomes
Primary Outcome Measures
Change in strength
Measured by a dynamometer
Secondary Outcome Measures
Change in range of motion
Measured by a goniometer reported in degrees
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05375071
Brief Title
BFR After Biceps Tendon Repair and MPFLR
Official Title
Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Biceps Tendon Rupture and Medial Patellofemoral Ligament Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Joint Dislocation, Bicep Tendon Rupture
Keywords
Bicep tendon repair, medial patellofemoral ligament reconstruction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional rehabilitation plus blood flow restriction (BFR) therapy
Arm Type
Experimental
Arm 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.
Arm Title
Conventional rehabilitation
Arm Type
Active Comparator
Arm Description
Following standard of care surgery, subjects will immediately be started in standard of care physical therapy.
Intervention Type
Other
Intervention Name(s)
Blood Flow Restriction (BFR) Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
Standard of care physical therapy consisting of a structured program progressing from range of motion to strength training and then functional tests
Primary Outcome Measure Information:
Title
Change in strength
Description
Measured by a dynamometer
Time Frame
Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months
Secondary Outcome Measure Information:
Title
Change in range of motion
Description
Measured by a goniometer reported in degrees
Time Frame
Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelechi Okoroha, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
BFR After Biceps Tendon Repair and MPFLR
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