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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to look at the effects of bone density on lower extremity loading mechanics using Blood Flow Restriction (BFR) to provide the control group for bone health. Hypothesis: The BFR group will have decreased bone mineral loss and improved functional performance compared to control group.

Research Team

Candice Dunkin, MAT

Principal Investigator

Parkview Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+