Micronized Dehydrated Human Amniotic Membrane Suspension in the Treatment of Lateral Epicondylitis (NCT01921569) | Clinical Trial Compass
TerminatedNot Applicable
Micronized Dehydrated Human Amniotic Membrane Suspension in the Treatment of Lateral Epicondylitis
Stopped: Study closed by sponsor
United States5 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 c…
What they're measuring
1
Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group.