40 Participants Needed

Blood Flow Restriction Therapy for Broken Bones

KG
NG
Overseen ByNicholas Giebel, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is Blood Flow Restriction Therapy different from other treatments for broken bones?

Blood Flow Restriction Therapy is unique because it uses a cuff to partially restrict blood flow during low-weight exercises, which helps improve muscle strength and function without the need for heavy weights, reducing stress on tissues and joints.12345

What data supports the effectiveness of the treatment Blood Flow Restriction Therapy for broken bones?

Research shows that Blood Flow Restriction (BFR) therapy can help improve strength and reduce pain more quickly in patients recovering from certain types of fractures, like those in the wrist, when combined with traditional rehabilitation. This suggests it might also be beneficial for other broken bones.678910

Who Is on the Research Team?

EN

Elizabeth Nolte, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for individuals recovering from a closed tibial plateau fracture who have undergone open reduction and internal fixation surgery. Participants should be willing to undergo physical therapy with or without blood flow restriction (BFR) therapy and be available for follow-up for one year.

Inclusion Criteria

I had surgery to fix a specific type of knee fracture.
I plan to go to physical therapy at a Froedtert location that offers BFR therapy.

Exclusion Criteria

At time of tibial plateau fracture has evidence of pelvic or spinal trauma
I am unable to give consent by myself.
I have no conditions that would prevent me from bearing weight after surgery.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard physical therapy or physical therapy with blood flow restriction therapy

14 weeks
2 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of knee strength, muscle atrophy, and motion analysis

12 months
Assessments at 3, 6, and 12 months postoperatively

What Are the Treatments Tested in This Trial?

Interventions

  • Blood Flow Restriction Therapy
Trial Overview The study compares standard physical therapy to the same therapy enhanced with BFR, which may improve muscle strength and recovery after a tibial plateau fracture. Patients will be randomly assigned to either group and tracked over the course of a year.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Rehabilitation Protocol and Blood Flow RestrictionExperimental Treatment2 Interventions
Group II: Rehabilitation ProtocolActive Control1 Intervention

Blood Flow Restriction Therapy is already approved in United States, Japan, European Union for the following indications:

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Approved in United States as Blood Flow Restriction Therapy for:
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Approved in Japan as KAATSU Training for:
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Approved in European Union as Blood Flow Restriction Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Published Research Related to This Trial

In a study of 32 elderly patients with distal femur fractures, those who were restricted to partial weight-bearing (PWB) showed significantly less actual weight-bearing and a delayed return to full weight-bearing (FWB) compared to those allowed immediate FWB, indicating that weight-bearing restrictions can hinder recovery.
The PWB group also exhibited a persistently lower walking cadence at 16 and 52 weeks post-surgery, suggesting that even temporary restrictions can have long-term negative effects on gait function, making such restrictions less advisable for recovery.
Temporary Partial Weight-Bearing Restriction in Elderly Patients Treated With a Plate Fixation After a Distal Femur Fracture had a Negative Long-Term Impact on Gait Recovery.Paulsson, M., Ekholm, C., Rolfson, O., et al.[2023]
Blood flow restriction (BFR) training is effective for increasing muscle size and strength, making it a promising option for treating musculoskeletal issues and aiding in postoperative recovery.
The article highlights the need for more research on BFR's applications in rehabilitation, while also sharing the authors' practical experiences with its use after surgery.
Use of Blood Flow Restriction Training for Postoperative Rehabilitation.Wilkinson, BG., Donnenwerth, JJ., Peterson, AR.[2019]
A survey of 250 orthopedic surgeons revealed that 59.8% currently use blood flow restriction (BFR) therapy, primarily for rehabilitation after anterior cruciate ligament reconstruction (ACLR), indicating its growing acceptance in clinical practice.
BFR therapy is typically applied 2-3 times per week, allowing patients to achieve benefits similar to high-intensity training while using lighter weights, which can be particularly useful for those recovering from musculoskeletal injuries.
Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients.Castle, JP., Tramer, JS., Turner, EHG., et al.[2023]

Citations

The effectiveness and safety of blood flow restriction training for the post-operation treatment of distal radius fracture. [2023]
BFR Training Improves Patients' Reported Outcomes, Strength, and Range of Motion After Casting for Colles' Fracture. [2023]
Safety and Efficacy of Blood Flow Restriction Therapy after Operative Management of Distal Radius Fractures: A Randomized Controlled Study. [2021]
Long-term results of functional treatment in intraarticular knee fractures and multifragment fractures of the shaft of femurs. [2016]
Temporary Partial Weight-Bearing Restriction in Elderly Patients Treated With a Plate Fixation After a Distal Femur Fracture had a Negative Long-Term Impact on Gait Recovery. [2023]
Use of Blood Flow Restriction Training for Postoperative Rehabilitation. [2019]
Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. [2023]
Efficacy and Safety of Blood Flow Restriction Training in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. [2022]
Blood flow restriction training in South Africa - a panel discussion. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. [2020]
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