The MONOVISC Hip Osteoarthritis Study

This is an interventional treatment trial for Osteoarthritis of the Hip Read More

Inclusion Criteria:

• Male or female ≥ 30 years old
• Body Mass Index (BMI) ≤ 35
• Clinical or radiographic diagnosis of hip osteoarthritis in the target hip, with a Kellgren-Lawrence (K/L) grade of 2 or 3.
• Walking pain NRS ≥ 4 and ≤ 8.
• Willing to discontinue all pain medications (except rescue medication) for 7 days prior to the first study injection and for the duration of the study.
• Willing to discontinue rescue medication for 48 hours prior to the first study injection.
• Willing to discontinue rescue medication for 48 hours prior to all follow-up visits
• Ability to tolerate acetaminophen (e.g. Tylenol).
• Must be physically and mentally willing and able to comply with pre and post-treatment scheduled clinical and radiographic evaluations
• Must voluntarily sign the Institutional Review Board approved Informed Consent Form.
• Must agree not to initiate cannabis therapy during the trial study period.

Exclusion Criteria:

• Radiographic evidence of osteonecrosis in the target hip
• NRS walking pain ≥ 3 the contralateral hip
• Clinically diagnosed osteoarthritis in either knee resulting in walking pain greater than NRS 5.
• Dependence on external stabilization for walking (e.g. cane, crutches, walker, etc.)
• Pain associated with lower back disorders that cannot be differentiated from target hip pain
• Major dysplasia or congenital abnormality
• Diagnosis of fibromyalgia
• Primary inflammatory arthropathy, or any other condition affecting the joint, including rheumatoid arthritis or gout in the target hip
• Any musculoskeletal condition that could impede efficacy measurement of the target hip
• Any major surgery, arthroplasty, or arthroscopy of the lower extremities in the past 6 months, or planned surgery during the study
• Infection of the injection site area
• Chronic skin disorders that could interfere with injection site evaluation
• Patients with asthma who require systemic use of corticosteroids
• Septic arthritis in any joint in the past 12 weeks
• For all patients: known hypersensitivity to hyaluronan, lidocaine, or acetaminophen
• For patients undergoing fluoroscopic injection guidance: known hypersensitivity to iodine-based fluoroscopic contrast agents, shellfish, or iodine
• Intra-articular steroid injection of the target hip within the last 3 months or hyaluronan injection of the target hip within the last 26 weeks
• Systemic corticosteroids within the last 12 weeks
• Glucosamine and/or chondroitin sulfate within last 4 weeks
• Currently on anticoagulation therapy, including aspirin therapy of > 81 mg/day (e.g. one daily "baby aspirin").
• Uncontrolled diabetes mellitus.
• Pregnant or breast feeding, or plan to be pregnant during the course of the study
• Any significant illness (metastasis of any type) that decreases the probability of the subject's survival to the 26 week endpoint
• Patients unwilling/unable to complete a pain/function and quality of life questionnaires
• Significant trauma to the index hip within 26 weeks of screening
• Is receiving workman's compensation, or is currently involved in litigation relating to hip osteoarthritis
• Is receiving prescription pain medication for conditions unrelated to hip osteoarthritis
• Chronic use of narcotics
• Unwilling to return for follow-up visits as described in this protocol
• Otherwise determined by the investigator to be medically unsuitable for participation in this study