← Back to Search

Blood Flow Restriction

Blood Flow Restriction Therapy for ACL Injury (ACLBONE Trial)

N/A
Recruiting
Led By Candice Dunkin, MAT
Research Sponsored by Candice Dunkin, MS, LAT, ATC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Athletes ages 16-22
Athletes undergoing ACL reconstruction with or without meniscal pathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 28 post surgery
Awards & highlights

ACLBONE Trial Summary

This trial will investigate the effects of bone density on lower extremity loading mechanics, with the use of Blood Flow Restriction as a control group for bone health. The hypothesis is that the group with the restriction will have less bone mineral loss and improved functional performance.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of Blood Flow Restriction may include discomfort at the tourniquet site, temporary numbness or tingling in the limb after release of the restriction. Standard rehab typically has minimal side effects but can include general soreness.

ACLBONE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am an athlete between 16 and 22 years old.
Select...
I am an athlete getting ACL surgery, with or without meniscus issues.

ACLBONE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 28 post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 28 post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Leg Weight distribution landing on force plates
Secondary outcome measures
Bone mineral density

ACLBONE Trial Design

2Treatment groups
Active Control
Group I: Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction GroupActive Control2 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 GroupActive Control1 Intervention
Standard post operative ACL rehab without Blood flow restriction

Find a Location

Who is running the clinical trial?

Candice Dunkin, MS, LAT, ATCLead Sponsor
Bryan BourcierLead Sponsor
Parkview HealthOTHER
9 Previous Clinical Trials
904 Total Patients Enrolled

Media Library

Delfi's PTS Personalized Tourniquet System (Blood Flow Restriction) Clinical Trial Eligibility Overview. Trial Name: NCT04682392 — N/A
Anterior Cruciate Ligament Tear Research Study Groups: Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group, Non Delfi PTS Personalized Tourniquet System for Blood Flow Restriction Group
Anterior Cruciate Ligament Tear Clinical Trial 2023: Delfi's PTS Personalized Tourniquet System Highlights & Side Effects. Trial Name: NCT04682392 — N/A
Delfi's PTS Personalized Tourniquet System (Blood Flow Restriction) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04682392 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for enrolment in this research project?

"To be eligible to participate in this program, applicants must have suffered a tear of the anterior cruciate ligament and fall between 16 and 22 years old. The study is currently trying to enlist 60 participants in total."

Answered by AI

Are there remaining openings for participants in this research endeavor?

"Affirmative. Clinicaltrials.gov states that the current recruitment effort, which was initially launched on February 17th 2021, is still ongoing. At this point in time, they are hoping to find 60 participants at a single medical centre."

Answered by AI

Is there a maximum age limit for participants of this research project?

"This experimental research has an age range of 16 to 22. 47 studies were performed for youths under the legal age and 26 participants over 65 years old."

Answered by AI

What is the maximum capacity for participants enrolled in this research endeavor?

"Affirmative. As per the details provided on clinicaltrials.gov, this investigation is currently searching for participants, having been first posted on February 17th 2021 and last updated September 1st 2022. The study requires 60 individuals at a single site to complete it."

Answered by AI
Recent research and studies
~10 spots leftby Jan 2025