Blood Flow Restriction Therapy for ACL Injury

(ACLBONE Trial)

Overseen By Candice Dunkin, MAT

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Candice Dunkin, MS, LAT, ATC

Disqualifiers: Cognitive impairment, Pregnancy, Neuromuscular disorders, others

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

Compensation: Varies

Number of Visits: 9

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how blood flow restriction (BFR) therapy can aid athletes in recovering after ACL (anterior cruciate ligament) surgery. The study uses Delfi's PTS Personalized Tourniquet System, a device for BFR therapy, to determine if restricting blood flow during rehabilitation results in less bone mineral loss and improved movement compared to standard rehab. Athletes aged 16-22 who have undergone ACL surgery, confirmed by an MRI, and have not previously used BFR, might be suitable candidates. As an unphased trial, this study provides athletes with a unique opportunity to contribute to innovative recovery methods.

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

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 Delfi's PTS Personalized Tourniquet System is safe for blood flow restriction therapy?

Research has shown that Blood Flow Restriction Therapy (BFRT) is generally safe for individuals recovering from ACL (anterior cruciate ligament) injuries. Studies have found promising results, with only minor side effects reported. For instance, one study found that teenagers who used BFRT after ACL surgery tolerated the treatment well, experiencing very few negative effects. Additionally, the Delfi's PTS Personalized Tourniquet System, used for BFRT, safely controls limb pressure, further ensuring patient safety. Overall, current data suggests that BFRT is well-tolerated and safe for use in rehabilitation settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to ACL injury rehabilitation that incorporates Blood Flow Restriction (BFR) using Delfi's PTS Personalized Tourniquet System. Unlike traditional rehab methods, which typically involve exercises without BFR, this technique aims to enhance muscle strength and recovery by limiting blood flow to the muscles, potentially leading to faster and more effective recovery. The Delfi system is designed to personalize the level of restriction, which could optimize the benefits of BFR and minimize risks, something standard rehab treatments do not offer. This innovative method could revolutionize post-operative ACL care by making rehab more efficient and tailored to individual needs.

What evidence suggests that Delfi's PTS Personalized Tourniquet System is effective for ACL injury rehabilitation?

Research has shown that Blood Flow Restriction (BFR) therapy can enhance recovery after ACL (anterior cruciate ligament) surgery. Studies have found that BFR increases muscle strength and prevents muscle loss. A review of multiple studies found that BFR effectively prevents muscle wasting in the legs after ACL surgery. In this trial, participants in one arm will use Delfi's Personalized Tourniquet System for BFR. Patients using this system have reported better recovery results compared to standard rehabilitation methods. This evidence suggests that BFR could be a valuable addition to ACL injury recovery. ^{1 2 4 6 7}

Who Is on the Research Team?

Candice Dunkin, MAT

Principal Investigator

Parkview Health

Are You a Good Fit for This Trial?

This trial is for athletes aged 16-22 who have an MRI-confirmed ACL tear and are undergoing reconstruction, with or without meniscal issues. It's not for those outside this age range, with weight bearing restrictions over 4 weeks, previous BFR use, neuromuscular disorders, cognitive impairments, re-tears or contralateral ACL tears, additional ligament/chondral repairs.

Inclusion Criteria

I am an athlete between 16 and 22 years old.

I am an athlete getting ACL surgery, with or without meniscus issues.

MRI confirming ACL tear

Exclusion Criteria

Athletes who do not or are unable to provide consent or assent (with Parental consent).

I have a cognitive impairment.

I am an athlete who has had surgery to fix ligaments or cartilage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative Assessment

Participants undergo MRI confirmation of ACL tear and are allocated to either the control or experimental group

1 week

1 visit (in-person)

Post-operative Initial Therapy

Initial post-op therapy session completed within 24-48 hours of surgery, including initial Dexascan and BFR instruction for the experimental group

1 week

1 visit (in-person)

Rehabilitation and Monitoring

Participants undergo rehabilitation with or without BFR, with Dexascans and force plate measurements every 4 weeks until 28 weeks

28 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including final assessments at week 28

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Delfi's PTS Personalized Tourniquet System
• Standard ACL rehab

Trial Overview The study compares the effects on bone density and functional performance between two groups: one using Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction during rehab and a control group receiving standard ACL rehabilitation.

How Is the Trial Designed?

Group I: Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group Active Control 2 Interventions

This group will use Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction for rehab.

Group II: Non Delfi PTS Personalized Tourniquet System for Blood Flow Restriction Group Active Control 1 Intervention

Standard post operative ACL rehab without Blood flow restriction

Who Is Running the Clinical Trial?

Candice Dunkin, MS, LAT, ATC

Lead Sponsor

Trials

1

Recruited

60+

Bryan Bourcier

Lead Sponsor

Trials

1

Recruited

60+

Parkview Health

Collaborator

Trials

10

Recruited

960+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11092532/

Outcomes of Blood Flow Restriction Training After ACL ... In elite NCAA Division I athletes, a statistically significant delay was observed in RTS with BFRT compared with standardized physical therapy alone after ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04390035

BFRT in Adolescents After ACL Reconstruction This is an interventional study that will examine effects of blood flow restriction training (BFRT) in adolescents aged 12-18 after anterior cruciate ...

3. patlynk.com patlynk.com/trial/NCT03141801

Blood Flow Restriction to Improve Muscle Strength After ... During exercise, patients will have the DELFI personalized tourniquet system applied over the quadriceps to restrict blood flow. The tourniquet will be set to a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7727417/

A SYSTEMATIC REVIEW OF THE EFFECTS OF BLOOD ... This review of the available evidence yields promising results regarding the use of BFR and LIRT in the remediation of femoral muscle atrophy after an ACL ...

5. researchgate.net researchgate.net/publication/381475234_Blood_Flow_Restriction_Enhances_Recovery_After_Anterior_Cruciate_Ligament_Reconstruction_A_Systematic_Review_and_Meta-Analysis_of_Randomized_Controlled_Trials

Blood Flow Restriction Enhances Recovery After Anterior ... Blood Flow Restriction Enhances Recovery After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

6. delfimedical.com delfimedical.com/pts-for-bfr/

PTS for BFR System - Delfi Medical The PTS Personalized Tourniquet System for Blood Flow Restriction (BFR) has been specifically designed to safely regulate and control tourniquet pressure.

7. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/32479-side-effects-and-patient-tolerance-with-the-u

Side Effects and Patient Tolerance with the Use of Blood Flow ... This preliminary report shows a very low and minor side effect profile as well as generally good tolerance to BFRT in the adolescent population after ACLR.