The MONOVISC Hip Osteoarthritis Study

Stopped early · Phase 3

Conditions studied: Osteoarthritis of the Hip

In brief

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).

Key facts

Study ID

NCT02698865

Run by

DePuy Mitek

People needed

220

Starts

2016-01-01

Expected to finish

2019-06-24

Last updated by the study team

2021-12-01

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Tucson Orthopedic Institute — Tucson, Arizona, United States
• CORE Orthopedic Medical Center — Encinitas, California, United States
• Eisenhower Medical Center/Desert Orthopedic Center — Rancho Mirage, California, United States
• Southern California Orthopedic Institute — Van Nuys, California, United States
• University of Colorado - Denver — Denver, Colorado, United States
• Denver Hip and Knee — Denver, Colorado, United States
• Center for Arthritis and Rheumatic Diseases — Miami, Florida, United States
• Integral Rheumatology & Immunology Specialists — Plantation, Florida, United States
• Emory Sports Complex — Brookhaven, Georgia, United States
• Iowa Orthopedic Center — Des Moines, Iowa, United States
• Sports Medicine North — Peabody, Massachusetts, United States
• MedSport - University of Michigan — Ann Arbor, Michigan, United States
• Professional Orthopedics — Cherry Hill, New Jersey, United States
• Hospital for Special Surgery — New York, New York, United States
• Columbia Medical Center — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• OrthoCarolina Sports Medicine Center — Charlotte, North Carolina, United States
• Sanford Health — Fargo, North Dakota, United States
• Cleveland Clinic — Garfield Heights, Ohio, United States
• Rothman Institute — Media, Pennsylvania, United States
• Texas Orthopedic Specialists — Bedford, Texas, United States
• Houston Methodist — Houston, Texas, United States
• Inov8 Orthopaedics — Houston, Texas, United States
• San Antonio Orthopaedic Group — San Antonio, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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