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

Primary Purpose

Epicondylitis, Lateral Humeral

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care Therapy
dHACM Injection
Normal Saline Injection
Sponsored by
MiMedx Group, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epicondylitis, Lateral Humeral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beacon Orthopaedics & Sports Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dHACM

Saline Injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group.

Secondary Outcome Measures

Proportion of patients achieving improvement in range of motion in the dHACM treatment group vs the control group.

Full Information

First Posted
July 18, 2013
Last Updated
September 23, 2015
Sponsor
MiMedx Group, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01921569
Brief Title
Micronized Dehydrated Human Amniotic Membrane Suspension in the Treatment of Lateral Epicondylitis
Official Title
Micronized Dehydrated Human Amniotic Membrane (dHACM) Suspension in the Treatment of Lateral Epicondylitis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Study closed by sponsor
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MiMedx Group, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epicondylitis, Lateral Humeral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dHACM
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline Injection
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
dHACM Injection
Intervention Description
Injection into affected area with micronized dHACM suspended with total volume of 1 cc normal saline.
Intervention Type
Other
Intervention Name(s)
Normal Saline Injection
Intervention Description
Injection into affected area with 1.0 cc normal saline solution instead of active agent.
Primary Outcome Measure Information:
Title
Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients achieving improvement in range of motion in the dHACM treatment group vs the control group.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Pain scores
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Kremchek, MD
Organizational Affiliation
Beacon Orthopaedics & Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beacon Orthopaedics & Sports Medicine
City
Sharonville
State/Province
Ohio
ZIP/Postal Code
45241
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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