Patellofemoral Joint DislocationNCT05375071
BFR After Biceps Tendon Repair and MPFLR
A study testing Blood Flow Restriction (BFR) Therapy and Physical Therapy in people with Patellofemoral Joint Dislocation and Bicep Tendon Rupture, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patellofemoral Joint Dislocation, Bicep Tendon Rupture
- What is being tested?
- Blood Flow Restriction (BFR) Therapy and Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2025to 29 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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- Subjects will be withdrawn from the study if they are unable to tolerate the BFR therapy. Additionally if they suffer from any complications of the therapy they will be withdrawn immediately.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 locations and contacts
1 site in 1 country.
About this study
Official title: Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Biceps Tendon Rupture and Medial Patellofemoral Ligament Reconstruction
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.
- Being tested
- Blood Flow Restriction (BFR) Therapy, Physical Therapy
- Keywords
- Bicep tendon repair, medial patellofemoral ligament reconstruction
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction (BFR) TherapyOther
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.
Physical TherapyOther
Standard of care physical therapy consisting of a structured program progressing from range of motion to strength training and then functional tests
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood Flow Restriction (BFR) Therapy |
| Conventional rehabilitation | Active comparator | Following standard of care surgery, subjects will immediately be started in standard of care physical therapy. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in strength
Measured by a dynamometer
Measured: 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
Measured: Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start29 Jul 2025
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Why it stopped: PI left Mayo Clinic, study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Joint DislocationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelechi Okoroha, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375071
- Sponsor's protocol ID
- 21-006791
- Status last verified
- Sep 2025
- First submitted
- 10 May 2022
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Biceps Tendon Rupture and Medial Patellofemoral Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05375071
- Acronym / sponsor ID
- 21-006791
- Keywords
- Bicep tendon repair, medial patellofemoral ligament reconstruction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left Mayo Clinic, study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional rehabilitation plus blood flow restriction (BFR) therapy | Experimental | Other: Blood Flow Restriction (BFR) TherapyFollowing 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. |
| Conventional rehabilitation | Active comparator | Other: Physical TherapyFollowing standard of care surgery, subjects will immediately be started in standard of care physical therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction (BFR) TherapyBFR 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. | Other | Conventional rehabilitation plus blood flow restriction (BFR) therapy |
| Physical TherapyStandard of care physical therapy consisting of a structured program progressing from range of motion to strength training and then functional tests | Other | Conventional rehabilitation |
Primary outcome
Change in strength
Time frame: Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months
Measured by a dynamometer
1 secondary outcome
Change in range of motion
Time frame: Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Patellofemoral Joint Dislocation
Recruiting
Blood Flow Restriction Training After Patellar INStability
Patellar Dislocation, Knee Injuries
Active, not recruitingObservational study
Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction
Medial Patellofemoral Dislocation
Not yet recruiting
Comparison Between Medial Patellofemoral Ligament Reconstruction Alone Versus Combined MPFL & Medial Patellotibial Ligament Reconstruction in the Management of Recurrent Lateral Patellar Dislocation in Children
Recurrent Patellar Displacement, MPFL
Recruiting
Effects of Preoperative Rehabilitation on Tendon Healing, Bone Mineral Density, and Cartilage After ACLR and Patellar Dislocation
Anterior Cruciate Ligament Rupture
RecruitingObservational study
JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Patellar Dislocation, Recurrent, Patellar Dislocation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelechi Okoroha, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction (BFR) Therapy and Physical Therapy in people with Patellofemoral Joint Dislocation and Bicep Tendon Rupture, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in strength (time frame: Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.