MONOVISC for Hip Joint Pain Relief
MONOVISC for Hip Joint Pain Relief
Obtain real world, post market data to confirm the clinical improvement and safety in
 patients treated with a single injection of MONOVISC for the symptomatic relief of
 osteoarthritis in the hip joint.
This is a prospective, post market clinical follow-up (PMCF) multi-center, open-label study
 to evaluate the residual risk of injections of MONOVISC for relief of pain in patients with a
 diagnosis of an osteoarthritic hip joint.

 The subjects in this study will be patients with a diagnosis of osteoarthritic (OA) joint who
 the investigator determines are appropriate candidates for treatment with a viscoelastic
 injection of MONOVISC.

 Up to 25 subjects will be enrolled at up to 20 investigational sites in the EU. Subject
 participation will last approximately 6 Months, with visits scheduled at Screening, Baseline,
 1 month, 3 month and 6 months.
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 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 ankle

 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 hip within 26 weeks of screening

 10. Chronic use of narcotics or cannabis.

 11. Ligament instability or tear in index joint.

 12. Diagnosis of fibromyalgia

 13. Diagnosis of osteonecrosis in index joint

 14. Subject has significant varus or valgus deformity greater than 10 degrees in either
 knee.

 15. Subject requires consistent use of an assistive device (e.g. wheelchair, walker, etc.)
 Occasional use of a cane is acceptable.

 16. Uncontrolled diabetes with HbA1c of >7%.

 17. 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.

 18. Subject is receiving or in litigation for worker's compensation.

 19. Otherwise determined by the investigator to be medically unsuitable for participation
 in this study.