The MONOVISC Hip Osteoarthritis Study

DePuy Synthes

Status and phase: Terminated; Phase 3

Conditions: Osteoarthritis of the Hip

Treatments: Device: Saline; Device: MONOVISC

Study type: Interventional

Funder types: Industry

Identifiers

NCT02698865

15-MVH-01

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 220 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups, including a placebo group

MONOVISC

Experimental group

Description:

MONOVISC High Molecular Weight Hyaluronan

Treatment:

Device: MONOVISC

Saline

Placebo Comparator group

Description:

Physiologic saline

Treatment:

Device: Saline