BFR Therapy for Post-Knee Arthroscopy Recovery

(ACL BFR Trial)

Overseen by James Genuario, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Must not be taking: Blood thinners

Disqualifiers: DVT, Pulmonary embolism, Stroke, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial investigates if using Blood Flow Restriction (BFR) therapy can help patients recover faster and stronger after knee surgery. BFR uses a special cuff to limit blood flow during exercise, making muscles grow and strengthen with less effort. The goal is to see if this method improves recovery better than standard rehabilitation alone.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are taking blood thinners, you may not be eligible to participate.

What data supports the effectiveness of the treatment BFR Therapy for post-knee arthroscopy recovery?

Research shows that Blood Flow Restriction Therapy (BFRT) can significantly improve knee function, muscle strength, and muscle thickness after knee surgery, compared to routine rehabilitation alone. This suggests that BFRT is effective in enhancing recovery after knee procedures. ^{1 2 3 4 5}

Is Blood Flow Restriction Therapy safe for humans?

Blood Flow Restriction Therapy (BFR) has been studied for various conditions and is generally considered safe when applied correctly, although there is no standardized application among practitioners. It involves using a cuff to restrict blood flow during exercise, which can help improve muscle strength and reduce pain. ^{1 5 6 7 8}

How does BFR therapy differ from other treatments for post-knee arthroscopy recovery?

BFR therapy is unique because it uses a tourniquet to partially restrict blood flow while exercising, which allows for muscle strengthening with low resistance. This method helps improve muscle strength and size without the need for heavy weights, making it particularly beneficial for recovery after knee surgery. ^{1 3 4 5 8}

Research Team

James Genuario, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for patients who've had knee arthroscopy and are rehabilitating from ACL reconstruction. They must be able to use a smartphone with the SAGA BFR app. It's not for those with MCL repairs, clotting disorders, recent severe cardiovascular or brain events, untreated blood pressure issues, pregnancy/postpartum within 6 months, poor English understanding, recent major injuries or surgeries on both knees close together.

Inclusion Criteria

Patients must have access to a smartphone device in order to utilize the SAGA BFR application for use. The application is free to use.

I had ACL surgery using tissue from my body or a donor, with or without meniscus removal.

Exclusion Criteria

I have high blood pressure that hasn't been treated.

I have low blood pressure that hasn't been treated.

I have had a recent severe muscle injury or trauma.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo post-operative physical therapy with or without Blood Flow Restriction (BFR) therapy following knee arthroscopy

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of knee extensor strength and other functional measures

2 years

Treatment Details

Interventions

• BFR Therapy (Other)

Trial Overview The study tests how effective blood flow restriction (BFR) therapy is when used in rehabilitation after knee surgery. Participants will use a BFR cuff along with an application that guides them through the process.

Participant Groups

Group I: Control Active Control 1 Intervention

Participants undergo standard post-operative physical therapy as prescribed by their surgeon.

Group II: BFR Cuff Active Control 1 Intervention

Patients undergo standard post-operative physical therapy as prescribed by their surgeon with the addition of a Blood Flow Restriction (BFR) cuff that is used during their exercises.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

Findings from Research

Blood flow restriction (BFR) training significantly improved thigh girth and strength in patients after knee arthroscopy, with the BFR group showing approximately double the strength gains compared to conventional therapy (74.59% vs 33.5%).

No adverse events were reported during the study, indicating that BFR is a safe and effective postoperative intervention for enhancing recovery after knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training After Knee Arthroscopy: A Randomized Controlled Pilot Study. Tennent, DJ., Hylden, CM., Johnson, AE., et al.[2022]

In a study of 48 patients who underwent total knee arthroplasty (TKA), blood flow restriction (BFR) therapy did not lead to significant improvements in quadriceps and hamstring strength compared to standard physical therapy (PT) alone after a 6-week program.

Both groups, regardless of BFR use, showed a high preference for avoiding revision TKA, with over 80% of patients opting not to undergo further surgery after completing their rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Blood Flow Restriction Therapy Improve Leg Strength in Patients With a Painful Total Knee Arthroplasty? Majors, IB., Mears, SC., Oholendt, CK., et al.[2023]

Blood flow restriction (BFR) training allows patients to safely exercise with low resistance after knee surgery, promoting muscle growth and strength despite reduced oxygen delivery to muscle cells.

Orthopaedic surgeons and physical therapists are increasingly using BFR in rehabilitation protocols, highlighting its effectiveness in postoperative recovery for knee injuries and surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Therapy After Knee Surgery: Indications, Safety Considerations, and Postoperative Protocol. DePhillipo, NN., Kennedy, MI., Aman, ZS., 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]

Blood flow restriction therapy (BFRT) uses a pneumatic cuff to restrict blood flow, creating a hypoxic environment that promotes muscle growth and strength gains, making it particularly beneficial for postoperative rehabilitation.

BFRT allows for effective low-load resistance training that achieves similar strength and hypertrophy results as higher-load training, but with less muscle swelling and pain, making it a safer option for those recovering from surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Therapy: An Evidence-Based Approach to Postoperative Rehabilitation. Watson, R., Sullivan, B., Stone, A., et al.[2023]

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]

In a study involving 32 adolescents (16 in the BFRT group and 16 in the control group), blood flow restriction training (BFRT) significantly improved isometric knee extension strength at both 3 months post-surgery and at the time of return to sport compared to traditional rehabilitation alone.

The BFRT group also reported better functional outcomes, as indicated by higher Pediatric International Knee Documentation Committee (Pedi-IKDC) scores, demonstrating enhanced patient-reported function after ACL reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early- and Late-Stage Benefits of Blood Flow Restriction Training on Knee Strength in Adolescents After Anterior Cruciate Ligament Reconstruction. Roman, DP., Burland, JP., Fredericks, A., et al.[2023]

References

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

Blood Flow Restriction Training After Knee Arthroscopy: A Randomized Controlled Pilot Study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Blood flow restriction training promotes functional recovery of knee joint in patients after arthroscopic partial meniscectomy: A randomized clinical trial. [2022]

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

Does Blood Flow Restriction Therapy Improve Leg Strength in Patients With a Painful Total Knee Arthroplasty? [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Therapy After Knee Surgery: Indications, Safety Considerations, and Postoperative Protocol. [2020]

5. 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]

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

Blood Flow Restriction Therapy: An Evidence-Based Approach to Postoperative Rehabilitation. [2023]

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

Early- and Late-Stage Benefits of Blood Flow Restriction Training on Knee Strength in Adolescents After Anterior Cruciate Ligament Reconstruction. [2023]