Clinical trial NCT01921569: 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
Overall status: TERMINATED
Phase: NA
Conditions: Epicondylitis, Lateral Humeral
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2013-08-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group.
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of patients achieving improvement in range of motion in the dHACM treatment group vs the control group.
timeFrame: 12 weeks
Other outcomes:
measure: Pain scores
timeFrame: 12 weeks
Locations:
city: Sharonville
country: United States
facility: Beacon Orthopaedics & Sports Medicine
state: Ohio
Study officials:
affiliation: Beacon Orthopaedics & Sports Medicine
name: Timothy Kremchek, MD
role: PRINCIPAL_INVESTIGATOR
References: