BFR Therapy for Post-Knee Arthroscopy Recovery

(ACL BFR Trial)

Overseen By Alexandra Orahovats, BS, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Blood thinners

Disqualifiers: DVT, Pulmonary embolism, Stroke, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether blood flow restriction (BFR) therapy can improve recovery after ACL surgery on the knee. It compares individuals using a special BFR cuff during exercises to those who do not. The trial aims to determine if BFR therapy enables faster and stronger return to activities. Individuals who have undergone knee surgery for ACL reconstruction (without meniscus repair) and are receiving physical therapy at a specific clinic in Denver may be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could enhance recovery methods for future patients.

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 prior data suggests that this BFR therapy is safe for post-knee arthroscopy recovery?

Research shows that blood flow restriction (BFR) therapy is generally safe after knee surgery. Studies have found no increased risk of deep vein thrombosis (DVT), a condition where blood clots form in deep veins, usually in the legs, when using BFR.

In previous research, patients who used BFR therapy after knee surgery did not experience more side effects than those who used regular therapy, suggesting that BFR is well-tolerated. The therapy involves using a cuff to limit blood flow during exercises, which can help strengthen muscles without stressing the joints excessively.

Overall, the safety data for BFR therapy is reassuring, with no major negative events reported in studies. This makes it a promising option for people recovering from knee surgeries like ACL reconstruction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Blood Flow Restriction (BFR) Therapy for post-knee arthroscopy recovery because it offers a unique way to enhance the standard physical therapy routine. Unlike typical rehabilitation exercises, BFR Therapy involves using a specialized cuff to restrict blood flow during workouts, which can lead to greater muscle strength gains while using lower intensities. This method might speed up recovery times and improve outcomes by allowing patients to build muscle strength without putting too much stress on healing tissues. By potentially reducing the time needed for recovery, BFR Therapy could offer a significant advantage over conventional post-operative care.

What evidence suggests that BFR Therapy is effective for post-knee arthroscopy recovery?

This trial will compare standard post-operative physical therapy with and without Blood Flow Restriction (BFR) therapy. Research has shown that BFR therapy can be beneficial after knee surgery, such as ACL reconstruction. Studies indicate that BFR can aid in building muscle strength and size, particularly in the thigh, during recovery. By partially blocking blood flow with a cuff, BFR might also help reduce short-term knee pain. However, research has not found significant improvements in overall knee function or long-term strength. Despite this, BFR is gaining popularity in rehabilitation due to these potential benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

James Genuario, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• BFR Therapy

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 of 40 patients recovering from arthroscopic partial meniscectomy, those who underwent blood flow restriction training (BFRT) alongside routine rehabilitation showed significantly better recovery in knee function, including improvements in pain, range of motion, and muscle strength after 8 weeks.

The RR + BFRT group demonstrated greater enhancements in quadriceps muscle strength and thickness compared to the routine rehabilitation group alone, indicating that BFRT can be an effective addition to standard rehabilitation protocols for knee recovery.

NCBI (Pubmed)

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. Ke, J., Zhou, X., Yang, Y., et al.[2022]

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 (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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27749358/

Blood Flow Restriction Training After Knee Arthroscopy Conclusions: This study suggests that BFR is an effective intervention after knee arthroscopy. Further investigation is warranted to elucidate the benefits of ...

2. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(18)30475-4/fulltext

The Role of Blood Flow Restriction Therapy Following ... The literature indicates that postoperative rehabilitation combined with BFR therapy may be effective in improving thigh muscle circumference, strength, and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1466853X25000744

Blood flow restriction training compared to conventional ... Blood flow restriction training can significantly reduce short-term knee pain. No significant effects on knee function or strength were identified.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6203234/

Blood Flow Restriction Therapy After Knee Surgery Blood flow restriction (BFR) training involves occluding venous outflow while maintaining arterial inflow by the application of an extremity tourniquet after ...

5. arthroscopysportsmedicineandrehabilitation.org arthroscopysportsmedicineandrehabilitation.org/article/S2666-061X(21)00215-7/fulltext

Blood Flow Restriction Enhances Rehabilitation and ... The use of blood flow restriction (BFR) within rehabilitation is rapidly increasing as further research is performed elucidating purported benefits.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03371901

NCT03371901 | Blood Flow Restriction Training in Patients ... The purpose of this study is to examine the feasibility of 9 weeks of supervised rehabilitation with BFR-LLST early after cartilage or meniscus repair in the ...