| Eligibility |
Inclusion Criteria:
1. Age 18 years or older
2. Diagnosis of chronic lateral epicondylosis defined as:
1. Pain reproducible on palpation of the lateral epicondyle / common extensor
origin, and
2. Pain reproducible during resisted wrist extension
3. Failed prior treatment for lateral epicondylosis
4. Able and willing to provide signed informed consent.
5. Subject must be willing to abstain from other peri-articular treatments of the elbow
for the duration of the study.
6. Subject is willing to discontinue all analgesics including NSAIDs, except
acetaminophen/paracetamol, at least seven days before the treatment injection and
through the completion of the study.
7. Subject is willing to use only acetaminophen/paracetamol (up to a maximum of 4.0 grams
per day per the package insert) for the treatment of joint pain for the duration of
the study. At least forty-eight hours prior to the Baseline Visit and each follow-up
visit, the subject is willing to discontinue use of acetaminophen/paracetamol.
Exclusion Criteria:
1. History of hypersensitivity to any of the ingredients in the hyaluronan
2. Infection or skin disease in the area of the injection site or elbow joint
3. Subject received a peri-articular injection of Hyaluronic Acid (HA) and/or steroid in
either elbow within 6 months of signing the informed consent form (ICF). A subject
will be excluded if they are planning to receive an HA or steroid injection (other
than the study injection) in either elbow during the course of this study.
4. Known inflammatory or autoimmune disorders, or other pre-existing medical conditions
that, in the opinion of the investigator, could impact healing or affect the ability
of the subject to complete the study and comply with the study requirements.
5. Subject is taking medications at the time of signing the ICF which could interfere
with the treatment procedure, healing and/or assessments. This includes but is not
limited to oral or injectable anticoagulant treatments, anti-aggregant platelet
treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular
protection is allowed if a stable regimen is maintained for the duration of the study.
6. Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical
(excluded in index elbow only) corticosteroid within 30 days of signing the ICF are
excluded. Topical corticosteroid use at any site other than the index elbow is
allowed.
7. Subject is a woman who is pregnant or breastfeeding at the Screening Visit or a woman
of child bearing potential who refuses to use effective contraception during the
course of the study.
8. Subject was involved in any other research study involving an investigational product,
or a new application of an approved product, within 60 days of signing the ICF.
9. Subject is receiving or in litigation for worker's compensation.
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