| Eligibility |
Inclusion Criteria:
1. Age 18 years or older
2. Body Mass Index (BMI) = 35 kg/m2
3. Diagnosis of symptomatic osteoarthritic joint in the index joint (Kellgren-Lawrence
grade I to III) to be treated with MONOVISC injection.
4. Failed conservative treatment for joint osteoarthritis.
5. NRS pain on walking =4 and =9 in the index joint.
6. Subject must be willing to abstain from other treatments of the index joint for the
duration of the study.
7. 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.
8. 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.
9. Subject is willing to maintain a stable dose of oral glucosamine and/or chondroitin
sulfate products throughout the study, if taken prior to signing the informed consent
form (ICF).
10. Able and willing to provide signed informed consent.
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 index joint
3. NRS pain on walking > 3 in the contralateral joint
4. NRS pain on walking > 3 in the ipsilateral knee or hip
5. Subject received an injection of Hyaluronic Acid (HA) and/or steroid in either joint
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 joint during the course of this study.
6. Known inflammatory or autoimmune disorders (including rheumatoid arthritis, gout), or
other pre-existing medical conditions that, in the opinion of the investigator, could
impact treatment of the index joint or affect the ability of the subject to accurately
complete the study questionnaires and comply with the study requirements.
7. 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.
8. Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical
(excluded in index joint only) corticosteroid prior 30 days of signing the ICF are
excluded. Topical corticosteroid use at any site other than the index joint is
allowed.
9. Significant trauma to the index ankle within 26 weeks of screening
10. Chronic use of narcotics or cannabis.
11. Ligament instability or tear in index joint.
12. Chronic impingement in the index joint requiring surgical treatment
13. Diagnosis of fibromyalgia
14. Diagnosis of osteonecrosis in index joint
15. Subject has significant varus or valgus deformity greater than 10 degrees in either
knee.
16. Subject requires consistent use of an assistive device (e.g. wheelchair, walker, etc.)
Occasional use of a cane is acceptable.
17. Uncontrolled diabetes with HbA1c of >7%.
18. 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.
19. Subject is receiving or in litigation for worker's compensation.
20. Otherwise determined by the investigator to be medically unsuitable for participation
in this study.
|
