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

40 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Research Team

Elizabeth Nolte, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of blood flow restriction training for the post-operation treatment of distal radius fracture. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

BFR Training Improves Patients' Reported Outcomes, Strength, and Range of Motion After Casting for Colles' Fracture. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Blood Flow Restriction Therapy after Operative Management of Distal Radius Fractures: A Randomized Controlled Study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term results of functional treatment in intraarticular knee fractures and multifragment fractures of the shaft of femurs. [2016]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Use of Blood Flow Restriction Training for Postoperative Rehabilitation. [2019]

7. India pubmed.ncbi.nlm.nih.gov

Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Blood Flow Restriction Training in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. [2022]

9. South Africa pubmed.ncbi.nlm.nih.gov

Blood flow restriction training in South Africa - a panel discussion. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. [2020]