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Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.

NCT02295020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-07-11

Study results available
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Summary

The objectives of the study are 1.) to evaluate pain relief following the application of the Bioskin Ten-7 knee brace and 2.) to determine if use of the Bioskin Ten-7 knee brace is more effective at reducing inflammation than standard of care alone using synovial fluid cytokine analysis and validated outcome measures.

Conditions

  • Osteoarthritis of the Knee

Interventions

DRUG

Standard treatment only

Standard treatment such as NSAIDs and injections

DEVICE

Standard treatment plus Bioskin Ten-7 knee brace

Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.

Sponsors & Collaborators

  • Cropper Medical

    lead INDUSTRY

Principal Investigators

  • Vinod Dasa, MD · LSUHSC-NO, Orthopaedic Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-04-30
Completion
2016-04-30

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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 NCT02295020 on ClinicalTrials.gov