The MONOVISC Hip Osteoarthritis Study

Study Overview
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Brief Summary
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This study is being done to determine the effectiveness of MONOVISC for the relief of pain and symptoms of osteoarthritis of the hip. Specifically, the study will determine if MONOVISC is more effective than a placebo treatment when delivered as intra-articular injections (injected directly into the hip joint). In this case, the placebo will be a dilute solution of salt water (saline).

Detailed Description
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The primary objective of this study is determine whether two intra-articular injections of MONOVISC, separated by 1 month, are superior to two intra-articular injections of physiologic saline, separated by 1 month, in relieving hip osteoarthritis pain, as determined by reduction in walking pain change from baseline.

Official Title
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A Pivotal Study Comparing Two Injections of MONOVISC to Two Injections of Saline in Patients With Osteoarthritis of the Hip

Conditions
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Osteoarthritis of the Hip

Intervention / Treatment
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* Device: MONOVISC
* Device: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MONOVISC<br>MONOVISC High Molecular Weight Hyaluronan | Device: MONOVISC<br>* Two (2) intra-articular injections of 4 ml MONOVISC, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy)<br>|
| Placebo Comparator: Saline<br>Physiologic saline | Device: Saline<br>* Two (2) intra-articular injections of 4 ml saline, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 180 | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. Walking Pain Score is measured by question A1 on the WOMAC 3.1 Index. The WOMAC questionnaire used in this study was administered in the Numerical rating scale (NRS) format. Question A1 on the WOMAC 3.1 Index measures the amount of pain that a participant has when walking on a flat surface. It is one question that is collected on a scale from 0 to 10 where a score of 0 indicates no pain and a score of 10 indicates extreme pain. | Baseline and Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. Walking Pain Score is measured by question A1 on the WOMAC 3.1 Index. The WOMAC questionnaire used in this study was administered in the Numerical rating scale (NRS) format. Question A1 on the WOMAC 3.1 Index measures the amount of pain that a participant has when walking on a flat surface. It is one question that is collected on a scale from 0 to 10 where a score of 0 indicates no pain and a score of 10 indicates extreme pain. | Baseline, Day 14, 28, 60 and 120 |