WithdrawnNot Applicable

Blood Flow Restriction Therapy Improves Tibial Plateau Fracture Recovery

Stopped: Study withdrawn prior to enrollment due to lack of available financial resources.

United States0Started 2025-12-01

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Collect participant knee injury consequences questionnaire

Timeframe: Prior to initiation of therapy, and 3, 6, and 12 months postoperatively

Collect participant reported function outcome questionnaire

Timeframe: Prior to initiation of therapy, and 3, 6, and 12 months postoperatively

Assess leg muscle atrophy

Timeframe: Prior to initiation of therapy and 3, 6, and 12 months postoperatively

Acquire motion analysis dynamics

Timeframe: 6 and 12 months postoperatively.

Acquire knee strength data.

Timeframe: 6 and 12 months postoperatively.

Trial details

NCT IDNCT06589115

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

View on ClinicalTrials.gov More Tibial Plateau Fractures trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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,

What they're measuring

Collect participant knee injury consequences questionnaire

Timeframe: Prior to initiation of therapy, and 3, 6, and 12 months postoperatively

Collect participant reported function outcome questionnaire

Timeframe: Prior to initiation of therapy, and 3, 6, and 12 months postoperatively

Assess leg muscle atrophy

Timeframe: Prior to initiation of therapy and 3, 6, and 12 months postoperatively

Acquire motion analysis dynamics

Timeframe: 6 and 12 months postoperatively.

Acquire knee strength data.

Timeframe: 6 and 12 months postoperatively.