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

NCT01921569 | Terminated

• 1 other identifier: AFLATEP001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving improvement in ASES elbow score in the dHACM treatment group vs the control group.

  12 weeks

Secondary Outcomes (1)

• Proportion of patients achieving improvement in range of motion in the dHACM treatment group vs the control group.

  12 weeks

Other Outcomes (1)

• Pain scores

  12 weeks

Study Arms (2)

dHACM

EXPERIMENTAL

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; Other: dHACM Injection

Saline Injection

PLACEBO COMPARATOR

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; Other: Normal Saline Injection

Interventions

Standard of Care Therapy 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.

Saline Injection; dHACM

dHACM Injection OTHER

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

dHACM

Normal Saline Injection OTHER

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

Saline Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (1)

Beacon Orthopaedics & Sports Medicine

Sharonville, Ohio, 45241, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Timothy Kremchek, MD

  Beacon Orthopaedics & Sports Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: August 13, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

US (1)