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Micronized Dehydrated Human Amniotic Membrane Suspension in the Treatment of Lateral Epicondylitis

NCT01921569 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-09-24

No results posted yet for this study

Summary

The purpose of this study is to determine whether micronized dehydrated human amniotic membrane (dHACM) suspension is more effective in reducing inflammation than conservative measures alone when used to treat acute/early lateral epicondylitis.

Conditions

  • Epicondylitis, Lateral Humeral

Interventions

BEHAVIORAL

Standard of Care Therapy

Rest, ice, compression, elevation (RICE), NSAID or salicylate medication for pain, Physical Therapy and stretching exercises, Reduction in impact activities, to include an arm sling.

OTHER

dHACM Injection

Injection into affected area with micronized dHACM suspended with total volume of 1 cc normal saline.

OTHER

Normal Saline Injection

Injection into affected area with 1.0 cc normal saline solution instead of active agent.

Sponsors & Collaborators

  • MiMedx Group, Inc.

    lead INDUSTRY

Principal Investigators

  • Timothy Kremchek, MD · Beacon Orthopaedics & Sports Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-03-31
Completion
2014-03-31

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 NCT01921569 on ClinicalTrials.gov