Blood Flow Restriction Therapy for Broken Bones

Overseen By Nicholas Giebel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: DVT, Vascular disease, BMI > 40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding blood flow restriction therapy to regular physical therapy aids recovery after surgery for a specific type of leg fracture. Researchers aim to determine if this combination improves movement, reduces muscle loss, and strengthens the knee more effectively than standard therapy alone. Participants will be randomly assigned to either standard therapy or therapy with added blood flow restriction and will be monitored for a year. This trial suits individuals who have undergone surgery for a closed tibial plateau fracture (a fracture just below the knee) and plan to attend therapy at specific locations. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery methods for future patients.

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.

What prior data suggests that blood flow restriction therapy is safe for patients with tibial plateau fractures?

Research shows that blood flow restriction (BFR) therapy is usually well-tolerated by patients. Studies have found that this therapy improves movement and reduces pain when combined with regular physical therapy. Reports suggest that BFR can help muscles grow and heal faster without causing major side effects. However, as with any treatment, responses may vary. Always consult the clinical team if there are any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Blood Flow Restriction Therapy for broken bones because it offers a new approach by combining standard physical therapy with a unique method that restricts blood flow to the affected area. This technique can enhance muscle strength and recovery without the need for heavy weights, which is particularly beneficial for individuals healing from fractures. While traditional care focuses on manual lymphatic drainage and cryotherapy, this therapy could potentially accelerate recovery and improve outcomes by stimulating muscle growth and healing even more efficiently.

What evidence suggests that blood flow restriction therapy might be an effective treatment for broken bones?

Research has shown that blood flow restriction (BFR) therapy can aid muscle growth and recovery. A special band or cuff reduces blood flow to the muscles, making low-intensity exercise mimic high-intensity exercise. Studies have found that BFR can increase muscle strength and size, even with light exercise. Some evidence also suggests that BFR might improve bone health and reduce pain. In this trial, one group will receive standard physical therapy, while another group will receive standard physical therapy supplemented with BFR therapy. This therapy is gaining popularity for its potential to aid recovery, especially after bone injuries like broken shins. ^{2 3 6 7 8}

Who Is on the Research Team?

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.

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?

Group I: Rehabilitation Protocol and Blood Flow Restriction Experimental Treatment 2 Interventions

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.

Group II: Rehabilitation Protocol Active Control 1 Intervention

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.

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

Approved in United States as Blood Flow Restriction Therapy for:

• Musculoskeletal injuries
• Pre-surgical strengthening
• Post-surgical rehabilitation
• Arthritis
• Tendinitis
• Non-union fractures
• IT band issues

Approved in Japan as KAATSU Training for:

• Muscle hypertrophy
• Muscle strengthening
• Rehabilitation after injury or surgery

Approved in European Union as Blood Flow Restriction Therapy for:

• Orthopedic rehabilitation
• Muscle strengthening
• Pain relief

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. Castle, JP., Tramer, JS., Turner, EHG., et al.[2023]

A randomized controlled trial with 26 healthy participants showed that low-load blood flow restriction (BFR) training significantly increased muscle strength and limb circumference compared to a control group, with no reported adverse events.

BFR training was effective for strengthening muscle groups both proximal and distal to the tourniquet, and even improved strength in the non-restricted extremity, suggesting a systemic benefit from this training method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. Bowman, EN., Elshaar, R., Milligan, H., et al.[2020]

Blood flow restriction training (BFRT) does not show significantly greater efficacy than conventional resistance training for treating knee osteoarthritis, based on a meta-analysis of 5 studies with low to moderate risk of bias.

BFRT may have a lower incidence of adverse events compared to high-load resistance training, suggesting it could be a safer option for patients with knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Blood Flow Restriction Training in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Wang, HN., Chen, Y., Cheng, L., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 considered a safe and effective method for improving musculoskeletal training outcomes, supported by 25 years of research.

There is a need for standardized, evidence-based protocols for BFR training among health professionals in South Africa to ensure its proper and safe application during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction training in South Africa - a panel discussion. Evans, RW., Ganda, J., van Schalkwyk, L., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8811521/

Blood Flow Restriction Therapy for Rehabilitation & Sport Blood flow restriction (BFR) is an expanding rehabilitation modality that uses a tourniquet to reduce arterial inflow and occlude venous outflow.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X24001652

Blood Flow Restriction Training: A Tool to Enhance ... BFRT has also been shown to have benefits for cardiovascular fitness, pain attenuation, and improvements in bone density (Table 1). The use of restricting ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07103252

Blood Flow Restriction Therapy to Optimize Muscle Size ... This study will assess the feasibility and effectiveness of blood flow restriction therapy in patients with tibia fractures (or lower leg bone).

4. physio-pedia.com physio-pedia.com/Blood_Flow_Restriction_Training

Blood Flow Restriction Training Blood Flow Restriction (BFR) training is a technique that combines low intensity exercise with blood flow occlusion that produces similar results to high ...

5. nature.com nature.com/articles/s41598-025-98053-5

Blood Flow Restriction Training & Bone Health in Older Adults While low-intensity blood flow restriction (LI-BFR) training has recently been shown to improve bone health, there remains limited evidence ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8448465/

Blood Flow Restriction Training - PMC Evidence suggests that blood flow restriction training can improve function and pain outcomes beyond traditional resistance training in individuals with joint ...

7. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/122641-the-impact-of-blood-flow-restriction-training-on-tibial-bone-stress-injury-rehabilitation-an-exploratory-case-series

The Impact of Blood Flow Restriction Training on Tibial ... The purpose of this study was to investigate the effects of lower extremity exercise with the addition of BFR upon bone mineral density, bone mineral content, ...

8. nm.org nm.org/conditions-and-care-areas/treatments/blood-flow-restriction-training

Blood Flow Restriction Training in Rehabilitation BFR training can: Speed up recovery. Strengthen the muscles in your affected limb. Help you achieve better outcomes. Your therapist will customize BFR ...