The MONOVISC Hip Osteoarthritis Study

Phase 3

Terminated

Conditions: Osteoarthritis of the Hip

Interventions: Device: MONOVISC
Device: Saline

Registration Number: NCT02698865

Lead Sponsor: DePuy Mitek

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 220

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MONOVISC	MONOVISC	MONOVISC High Molecular Weight Hyaluronan
Saline	Saline	Physiologic saline

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 180	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
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	Baseline, 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.

Trial Locations

Locations (27): 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
Scroll for more (17 remaining)
Tucson Orthopedic Institute
🇺🇸Tucson, Arizona, United States