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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.
ClinicalTrials.gov Identifier:
NCT01921569
First received: July 18, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Epicondylitis, Lateral Humeral
Behavioral: Standard of Care Therapy
Drug: dHACM Injection
Drug: Normal Saline Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Micronized Dehydrated Human Amniotic Membrane (dHACM) Suspension in the Treatment of Lateral Epicondylitis.

Resource links provided by NLM:


Further study details as provided by MiMedx Group, Inc.:

Primary Outcome Measures:
  • Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients achieving improvement in range of motion in the dHACM treatment group vs the control group. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Pain scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: June 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Drug: dHACM Injection
Injection into affected area with micronized dHACM suspended with total volume of 1 cc normal saline.
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.
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.
Drug: Normal Saline Injection
Injection into affected area with 1.0 cc normal saline solution instead of active agent.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01921569

Locations
United States, Ohio
Beacon Orthopaedics & Sports Medicine
Sharonville, Ohio, United States, 45241
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
Principal Investigator: Timothy Kremchek, MD Beacon Orthopaedics & Sports Medicine
  More Information

No publications provided

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT01921569     History of Changes
Other Study ID Numbers: AFLATEP001
Study First Received: July 18, 2013
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dehydration
Tennis Elbow
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2014