The MONOVISC Hip Osteoarthritis Study

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

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).

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis of the Hip
• Intervention / Treatment: Device: MONOVISC; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Tucson Orthopedic Institute
  • California
    • Encinitas, California, United States, 92024
      • CORE Orthopedic Medical Center
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Medical Center/Desert Orthopedic Center
    • Van Nuys, California, United States, 91405
      • Southern California Orthopedic Institute
  • Colorado
    • Denver, Colorado, United States, 80111
      • University of Colorado - Denver
    • Denver, Colorado, United States, 80134
      • Denver Hip and Knee
  • Florida
    • Miami, Florida, United States, 33173
      • Center for Arthritis and Rheumatic Diseases
    • Plantation, Florida, United States, 33324
      • Integral Rheumatology & Immunology Specialists
  • Georgia
    • Brookhaven, Georgia, United States, 30329
      • Emory Sports Complex
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Iowa Orthopedic Center
  • Massachusetts
    • Peabody, Massachusetts, United States, 01960
      • Sports Medicine North
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • MedSport - University of Michigan
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
      • Professional Orthopedics
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • New York, New York, United States, 10032
      • Columbia Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Sports Medicine Center
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Sanford Health
  • Ohio
    • Garfield Heights, Ohio, United States, 44125
      • Cleveland Clinic
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Rothman Institute
  • Texas
    • Bedford, Texas, United States, 76021
      • Texas Orthopedic Specialists
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • Houston, Texas, United States, 77043
      • Inov8 Orthopaedics
    • San Antonio, Texas, United States, 78216
      • San Antonio Orthopaedic Group
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
    • Lansdowne Town Center, Virginia, United States, 20176
      • National Sports Medicine Institute
    • Lynchburg, Virginia, United States, 24501
      • OrthoVirginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: DePuy Mitek
• Investigators: Study Director: Brooks J Story, PhD, DePuy Synthes Mitek Sports Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): June 24, 2019

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimate): March 4, 2016

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 15-MVH-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes