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

Micronized Dehydrated Human Amniotic Membrane (dHACM) Suspension in the Treatment of Lateral Epicondylitis.

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.

Study Overview

• Status: Terminated
• Conditions: Epicondylitis, Lateral Humeral
• Intervention / Treatment: Behavioral: Standard of Care Therapy; Other: dHACM Injection; Other: Normal Saline Injection

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Sharonville, Ohio, United States, 45241
      • Beacon Orthopaedics & Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other: 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.; Other: Normal Saline Injection; Injection into affected area with 1.0 cc normal saline solution instead of active agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients achieving improvement in range of motion in the dHACM treatment group vs the control group.	12 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Pain scores	12 weeks

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.
• Investigators: Principal Investigator: Timothy Kremchek, MD, Beacon Orthopaedics & Sports Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: July 18, 2013
• First Submitted That Met QC Criteria: August 12, 2013
• First Posted (Estimate): August 13, 2013

Study Record Updates

• Last Update Posted (Estimate): September 24, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: AFLATEP001