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

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ClinicalTrials.gov Identifier: NCT01921569
Recruitment Status : Terminated (Study closed by sponsor)
First Posted : August 13, 2013
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.

Tracking Information
First Submitted Date  ICMJE July 18, 2013
First Posted Date  ICMJE August 13, 2013
Last Update Posted Date September 24, 2015
Study Start Date  ICMJE June 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2013)
Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group. [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01921569 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2013)
Proportion of patients achieving improvement in range of motion in the dHACM treatment group vs the control group. [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 12, 2013)
Pain scores [ Time Frame: 12 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Micronized Dehydrated Human Amniotic Membrane Suspension in the Treatment of Lateral Epicondylitis
Official Title  ICMJE Micronized Dehydrated Human Amniotic Membrane (dHACM) Suspension in the Treatment of Lateral Epicondylitis.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Epicondylitis, Lateral Humeral
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: dHACM
    Standard of Care Therapy plus dHACM injection at initial visit, to be repeated if symptoms persist at the time of week 4 and week 8 follow up visits.
    Interventions:
    • Behavioral: Standard of Care Therapy
    • Other: dHACM Injection
  • Placebo Comparator: Saline Injection
    Standard of Care Therapy plus normal saline injection instead of active agent at initial visit, to be repeated if symptoms persist at the time of week 4 and week 8 follow up visits.
    Interventions:
    • Behavioral: Standard of Care Therapy
    • Other: Normal Saline Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 12, 2014)
5
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2013)
56
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years old.
  • Medicare patients may be selected.
  • Both male and female patients will be selected.
  • A negative x-ray of the elbow
  • Diagnosis of lateral epicondylitis by history and exam with symptoms for no longer than one year.
  • Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
  • Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
  • Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

Exclusion Criteria:

  • Prior surgery at the site
  • Site exhibits clinical signs and symptoms of infection.
  • History of chronic soft tissue inflammation of more than 6 months.
  • A positive X-ray for fracture or significant anatomic abnormality including fracture, advanced arthritis, excessive calcification, etc.
  • No history of corticosteroid injection within the past 30 days.
  • Joint instability
  • No rheumatologic conditions involving the elbow.
  • No evidence of significant neurological entrapment or neurological disease of the forearm
  • Concurrent cervical radiculopathy
  • The presence of comorbidities that can be confused with or can exacerbate the condition including:

    • Previous elbow trauma
    • Previous elbow surgery
  • Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study. (i.e. a one month "washout period" for these drugs.)
  • Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
  • History of radiation at the site.
  • Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
  • Patients who are unable to understand the aims and objectives of the trial.
  • Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
  • Pregnant or breast feeding. No pregnancy within the past 6 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01921569
Other Study ID Numbers  ICMJE AFLATEP001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MiMedx Group, Inc.
Study Sponsor  ICMJE MiMedx Group, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy Kremchek, MD Beacon Orthopaedics & Sports Medicine
PRS Account MiMedx Group, Inc.
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP