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

Epicondylitis, Lateral Humeral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01921569
• Other study ID #: AFLATEP001
• Status: Terminated
• Phase: N/A
• First received: July 18, 2013
• Last updated: September 23, 2015
• Start date: June 2013
• Est. completion date: March 2014

Study information

• Verified date: September 2015
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epicondylitis, Lateral Humeral
• Tennis Elbow

Intervention

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

Locations

Country	Name	City	State
United States	Beacon Orthopaedics & Sports Medicine	Sharonville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain scores		12 weeks	No
Primary	Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group.		12 weeks	No
Secondary	Proportion of patients achieving improvement in range of motion in the dHACM treatment group vs the control group.		12 weeks	No