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BFR Therapy After ACL Reconstruction

NCT03794570 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-12-04

No results posted yet for this study

Summary

This study is a prospective, double-blinded, randomized control trial examining the effect of blood flow restriction (BFR) therapy on reducing post-operative quadriceps atrophy in patients undergoing anterior cruciate ligament reconstruction (ACLR). Following ACLR, patients will undergo a rehabilitation protocol either w/ BFR therapy or sham BFR therapy.

Conditions

  • ACL Injury
  • Quadriceps Muscle Atrophy

Interventions

DEVICE

Blood flow restriction therapy - with Delfi Personalized Tourniquet System

Physical therapy performed with Blood flow restriction therapy tourniquet inflated to 80% limb occlusion pressure

DEVICE

Sham blood flow restriction therapy - with Delfi Personalized Tourniquet System

Physical therapy performed with Blood flow restriction therapy tourniquet inflated to only minimal pressure

Sponsors & Collaborators

  • Steadman Philippon Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2019-06-01
Completion
2019-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03794570 on ClinicalTrials.gov