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

NCT ID: NCT01921569

Last Updated: 2015-09-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-03-31

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.

Conditions

Epicondylitis, Lateral Humeral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Standard of Care Therapy

Intervention Type: BEHAVIORAL

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.

dHACM Injection

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

Standard of Care Therapy

Intervention Type: BEHAVIORAL

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.

Normal Saline Injection

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

dHACM Injection

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

Intervention Type: OTHER

Normal Saline Injection

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MiMedx Group, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Kremchek, MD

Role: PRINCIPAL_INVESTIGATOR

Beacon Orthopaedics & Sports Medicine

Locations

Beacon Orthopaedics & Sports Medicine

Sharonville, Ohio, United States

Countries

United States

Other Identifiers

AFLATEP001

Identifier Type: -

Identifier Source: org_study_id