Tibial Plateau FracturesNCT06589115
Blood Flow Restriction Therapy Improves Tibial Plateau Fracture Recovery
A study testing Blood Flow Restriction Cuff and Physical Therapy in people with Tibial Plateau Fractures, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The goal of this clinical trial is to investigates the effectiveness of physical therapy augmented with blood flow restriction (BFR) therapy relative to standard physical therapy in patients after an open reduction and internal fixation of a closed tibial plateau fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Plateau Fractures
- What is being tested?
- Blood Flow Restriction Cuff 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
- 1 Dec 2025to 31 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Equal to or greater than 18 years of age
- ORIF (open reduction and internal fixation) of a closed unicondylar tibial plateau fracture
- Planning to attend physical therapy at one of the eligible Froedtert locations with BFR therapy capabilities
Who cannot join
- Patient is unable to provide consent
- At time of tibial plateau fracture has evidence of a(n)
- Open fracture(s)
- Fracture(s) with associated vascular injury,
- Fracture(s) with extensive soft tissue injury preventing the ability to apply a tourniquet
- Ipsilateral or contralateral lower extremity fracture(s)
Show all 11Show fewer
- Pelvic or spinal trauma
- History of deep venous thrombosis (DVT)
- History of peripheral vascular disease
- Body Mass Index \> 40
- Any history of condition that would affect the patient's ability to bear weight as tolerated post-operatively.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The goal of this clinical trial is to investigates the effectiveness of physical therapy augmented with blood flow restriction (BFR) therapy relative to standard physical therapy in patients after an open reduction and internal fixation of a closed tibial plateau fracture.
The main aims are:
- Collect functional and patient self-reported outcomes data
- Assess leg muscle atrophy
- Acquire motion analysis dynamics and knee strength data.
Participants will be randomized into either a rehabilitation protocol or that protocol with blood flow restriction and be followed for 1 year.
Read the detailed description
Standardized Surveys: Participants will complete two patient reported functional outcome assessments via questionnaires, the KOOS (Knee Injury and Osteoarthritis Outcome Score) and the PROMIS PF (Patient-Reported Outcomes Measurement Information System Physical Function). The PROMIS PF is a computer adaptive, reliable, and validated instrument used to evaluate patient-reported outcome measures regarding physical function ranging from low to very high, along with mental and social well-being. The KOOS is a knee-specific self-administered questionnaire that assesses five long-term and short-term outcomes of knee injury: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
Blood Flow Restriction Cuff: Along with standard physical therapy, three of the standardized exercises will be performed while wearing an Owens Delfi blood flow restriction cuff (Delfi Medical, San Antonio, TX). To attain partial vascular occlusion, an easy-fit nylon cuff (11.5 cm x 86 cm, 5mm thick) will be placed as proximal as possible on the patient's thigh of the involved leg. Total limb occlusion pressure will be individualized and set between 60% to 80% of the complete arterial occlusion pressure. Limb occlusive pressure will be calculated with the participants in the position for exercise to ensure accurate calculation of limb occlusive pressure. This individual approach prevents excessive pressure in individuals with lower limb occlusion pressures.
Tape Measure: A non-elastic, flexible plastic tape measure will be used. The thigh circumference will be measured at a point 15 cm proximal to the superior pole of the patella. Calf circumference will be measured at the point of greatest circumference while subjects are supine with the knee extended; subcutaneous tissues will not be compressed.
Motion Analysis: Quantitative motion analysis will be conducted at the Medical College of Wisconsin (MCW) Center for Motion Analysis (CMA) using a motion analysis camera system and wireless surface electromyography (EMG) electrodes to determine temporal-spatial parameters, kinematics, kinetics, and muscle activity during walking, sit-to-stand, forward lunge, and step-up-and-over tasks. A validated standardized gait model will be used.
Leg Strength Assessment: Isometric, concentric and eccentric strength will be assessed using the Biodex System 3 Pro dynamometer. Each subject will undergo bilateral leg strength testing.
- Conditions
- Tibial Plateau Fractures
- Being tested
- Blood Flow Restriction Cuff, Physical Therapy
- Medical subject headings
- Tibial Plateau Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction CuffOther
The standardized exercises will be performed while wearing a blood flow restriction cuff.
Physical TherapyOther
Standard physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Protocol | Active comparator | Standard physical therapy will be performed according to the clinic standard with manual lymphatic drainage, cryotherapy, and 20 minutes of physical therapy two times a week for fourteen weeks following the initial post-operative visit. Receives: Other: Physical Therapy |
| Rehabilitation Protocol and Blood Flow Restriction | Experimental | In addition to the standard physical therapy, the blood flow restriction group will also begin standard physical therapy care supplemented with blood flow restriction therapy two times a week for 10 weeks after wound healing. Receives: Other: Blood Flow Restriction Cuff; Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect participant knee injury consequences questionnaire
Participants will complete the KOOS (Knee Injury and Osteoarthritis Outcome Score) questionnaire.
Measured: Prior to initiation of therapy, and 3, 6, and 12 months postoperatively
Collect participant reported function outcome questionnaire
Participants will complete the PROMIS PF (Patient-Reported Outcomes Measurement Information System Physical Function) questionnaire.
Measured: Prior to initiation of therapy, and 3, 6, and 12 months postoperatively
Assess leg muscle atrophy
Bilateral thigh and calf circumferential girth measurements will be taken once prior to initiation of therapy and then additionally at 3, 6, and 12 months postoperatively as a surrogate for muscle mass.
Measured: Prior to initiation of therapy and 3, 6, and 12 months postoperatively
Acquire motion analysis dynamics
Participants will undergo 3D motion analysis with concurrent surface EMG (i.e., the electrical activity of the muscle) during walking, sit-to-stand, forward lunge, and step-up-and-over tasks.
Measured: 6 and 12 months postoperatively.
Acquire knee strength data.
Bilateral knee strength (i.e., muscle force production) will be assessed for isometric, concentric and eccentric muscle contractions using a Biodex dynamometer.
Measured: 6 and 12 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Why it stopped: Study withdrawn prior to enrollment due to lack of available financial resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Plateau FracturesStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Nolte, Medical College of Wisconsin
- Investigators
- Elizabeth Nolte, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589115
- Sponsor's protocol ID
- PRO00047532
- Status last verified
- Nov 2025
- First submitted
- 15 Jul 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Therapy Improves Tibial Plateau Fracture Recovery
- ClinicalTrials.gov ID
- NCT06589115
- Acronym / sponsor ID
- PRO00047532
- Conditions
- Tibial Plateau Fractures
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn prior to enrollment due to lack of available financial resources.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Sep 2024 (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 goal of this clinical trial is to investigates the effectiveness of physical therapy augmented with blood flow restriction (BFR) therapy relative to standard physical therapy in patients after an open reduction and internal fixation of a closed tibial plateau fracture.
The main aims are:
- Collect functional and patient self-reported outcomes data
- Assess leg muscle atrophy
- Acquire motion analysis dynamics and knee strength data.
Participants will be randomized into either a rehabilitation protocol or that protocol with blood flow restriction and be followed for 1 year.
Detailed description
Standardized Surveys: Participants will complete two patient reported functional outcome assessments via questionnaires, the KOOS (Knee Injury and Osteoarthritis Outcome Score) and the PROMIS PF (Patient-Reported Outcomes Measurement Information System Physical Function). The PROMIS PF is a computer adaptive, reliable, and validated instrument used to evaluate patient-reported outcome measures regarding physical function ranging from low to very high, along with mental and social well-being. The KOOS is a knee-specific self-administered questionnaire that assesses five long-term and short-term outcomes of knee injury: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
Blood Flow Restriction Cuff: Along with standard physical therapy, three of the standardized exercises will be performed while wearing an Owens Delfi blood flow restriction cuff (Delfi Medical, San Antonio, TX). To attain partial vascular occlusion, an easy-fit nylon cuff (11.5 cm x 86 cm, 5mm thick) will be placed as proximal as possible on the patient's thigh of the involved leg. Total limb occlusion pressure will be individualized and set between 60% to 80% of the complete arterial occlusion pressure. Limb occlusive pressure will be calculated with the participants in the position for exercise to ensure accurate calculation of limb occlusive pressure. This individual approach prevents excessive pressure in individuals with lower limb occlusion pressures.
Tape Measure: A non-elastic, flexible plastic tape measure will be used. The thigh circumference will be measured at a point 15 cm proximal to the superior pole of the patella. Calf circumference will be measured at the point of greatest circumference while subjects are supine with the knee extended; subcutaneous tissues will not be compressed.
Motion Analysis: Quantitative motion analysis will be conducted at the Medical College of Wisconsin (MCW) Center for Motion Analysis (CMA) using a motion analysis camera system and wireless surface electromyography (EMG) electrodes to determine temporal-spatial parameters, kinematics, kinetics, and muscle activity during walking, sit-to-stand, forward lunge, and step-up-and-over tasks. A validated standardized gait model will be used.
Leg Strength Assessment: Isometric, concentric and eccentric strength will be assessed using the Biodex System 3 Pro dynamometer. Each subject will undergo bilateral leg strength testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Protocol | Active comparator | Other: Physical TherapyStandard physical therapy will be performed according to the clinic standard with manual lymphatic drainage, cryotherapy, and 20 minutes of physical therapy two times a week for fourteen weeks following the initial post-operative visit. |
| Rehabilitation Protocol and Blood Flow Restriction | Experimental | Other: Blood Flow Restriction Cuff, Other: Physical TherapyIn addition to the standard physical therapy, the blood flow restriction group will also begin standard physical therapy care supplemented with blood flow restriction therapy two times a week for 10 weeks after wound healing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Equal to or greater than 18 years of age
- ORIF (open reduction and internal fixation) of a closed unicondylar tibial plateau fracture
- Planning to attend physical therapy at one of the eligible Froedtert locations with BFR therapy capabilities
Key exclusion criteria (11 listed)
- Patient is unable to provide consent
- At time of tibial plateau fracture has evidence of a(n)
- History of deep venous thrombosis (DVT)
- History of peripheral vascular disease
- Body Mass Index \> 40
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 CuffThe standardized exercises will be performed while wearing a blood flow restriction cuff. | Other | Rehabilitation Protocol and Blood Flow Restriction |
| Physical TherapyStandard physical therapy | Other | Rehabilitation Protocol, Rehabilitation Protocol and Blood Flow Restriction |
Primary outcome
Collect participant knee injury consequences questionnaire
Time frame: Prior to initiation of therapy, and 3, 6, and 12 months postoperatively
Participants will complete the KOOS (Knee Injury and Osteoarthritis Outcome Score) questionnaire.
Collect participant reported function outcome questionnaire
Time frame: Prior to initiation of therapy, and 3, 6, and 12 months postoperatively
Participants will complete the PROMIS PF (Patient-Reported Outcomes Measurement Information System Physical Function) questionnaire.
Assess leg muscle atrophy
Time frame: Prior to initiation of therapy and 3, 6, and 12 months postoperatively
Bilateral thigh and calf circumferential girth measurements will be taken once prior to initiation of therapy and then additionally at 3, 6, and 12 months postoperatively as a surrogate for muscle mass.
Acquire motion analysis dynamics
Time frame: 6 and 12 months postoperatively.
Participants will undergo 3D motion analysis with concurrent surface EMG (i.e., the electrical activity of the muscle) during walking, sit-to-stand, forward lunge, and step-up-and-over tasks.
Acquire knee strength data.
Time frame: 6 and 12 months postoperatively.
Bilateral knee strength (i.e., muscle force production) will be assessed for isometric, concentric and eccentric muscle contractions using a Biodex dynamometer.
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 10 Nov 2025.
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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.
Elizabeth Nolte, MD principal investigator
Medical College of Wisconsin
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 Cuff and Physical Therapy in people with Tibial Plateau Fractures, run by Medical College of Wisconsin 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 3 inclusion and 11 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 10 Nov 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?
Collect participant knee injury consequences questionnaire (time frame: Prior to initiation of therapy, and 3, 6, and 12 months postoperatively). The study lists 5 primary outcomes in all. 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 10 Nov 2025.