MedTrace Logo

Moderated Blood Flow Restriction After Anterior Cruciate Ligament Reconstruction

NCT02911909 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-03-11

Study results available
· View outcomes & findings →

Summary

The aim of this study is to determine if there is a difference in post operative rehabilitation after anterior cruciate ligament (ACL) reconstruction surgery while using moderated blood flow therapy vs. standard physical therapy. All patients undergoing ACL reconstruction, between the ages of 18-30, that consent to taking part in the study, and meet eligibility criteria, will be included in the study. Patients will be followed for two years to determine any differences in muscle strength, thigh circumference, knee range of motion, pain, functional and activity levels, patient satisfaction, levels of Human growth hormone HGH), Insulin-like Growth Factor (IGF), and Creatine Kinase (CK), KT2000, and Lachman physical examination.

Conditions

  • Anterior Cruciate Ligament Tear

Interventions

DEVICE

Delfi

Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.

OTHER

Standard rehabilitation

Patients will receive standard of care post-operative ACL reconstruction rehabilitation

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • James Cook · University of MO-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2019-10-21
Completion
2019-10-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02911909 on ClinicalTrials.gov