The MONOVISC Hip Osteoarthritis Study

NCT02698865 | Terminated Phase 3 Results FDA Device

• 1 other identifier: 15-MVH-01
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 27

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).

Conditions

Osteoarthritis of the Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

MONOVISC

EXPERIMENTAL

MONOVISC High Molecular Weight Hyaluronan

Device: MONOVISC

Saline

PLACEBO COMPARATOR

Physiologic saline

Device: Saline

Interventions

MONOVISC DEVICE

Two (2) intra-articular injections of 4 ml MONOVISC, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy)

MONOVISC

Saline DEVICE

Two (2) intra-articular injections of 4 ml saline, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy)

Saline

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• DePuy Mitek: lead

Study Sites (27)

Tucson Orthopedic Institute

Tucson, Arizona, 85712, United States

Location

CORE Orthopedic Medical Center

Encinitas, California, 92024, United States

Location

Eisenhower Medical Center/Desert Orthopedic Center

Rancho Mirage, California, 92270, United States

Location

Southern California Orthopedic Institute

Van Nuys, California, 91405, United States

Location

University of Colorado - Denver

Denver, Colorado, 80111, United States

Location

Denver Hip and Knee

Denver, Colorado, 80134, United States

Location

Center for Arthritis and Rheumatic Diseases

Miami, Florida, 33173, United States

Location

Integral Rheumatology & Immunology Specialists

Plantation, Florida, 33324, United States

Location

Emory Sports Complex

Brookhaven, Georgia, 30329, United States

Location

Iowa Orthopedic Center

Des Moines, Iowa, 50314, United States

Location

Sports Medicine North

Peabody, Massachusetts, 01960, United States

Location

MedSport - University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

Professional Orthopedics

Cherry Hill, New Jersey, 08034, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Columbia Medical Center

New York, New York, 10032, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

OrthoCarolina Sports Medicine Center

Charlotte, North Carolina, 28207, United States

Location

Sanford Health

Fargo, North Dakota, 58103, United States

Location

Cleveland Clinic

Garfield Heights, Ohio, 44125, United States

Location

Rothman Institute

Media, Pennsylvania, 19063, United States

Location

Texas Orthopedic Specialists

Bedford, Texas, 76021, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Inov8 Orthopaedics

Houston, Texas, 77043, United States

Location

San Antonio Orthopaedic Group

San Antonio, Texas, 78216, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

National Sports Medicine Institute

Lansdowne Town Center, Virginia, 20176, United States

Location

OrthoVirginia

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

No Study limitation was reported for this study.

Results Point of Contact

• Title: FRANCHISE MEDICAL DIRECTOR
• Organization: DePuy Synthes

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Brooks J Story, PhD

  DePuy Synthes Mitek Sports Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 4, 2016
• Study Start: January 1, 2016
• Primary Completion: March 15, 2019
• Study Completion: June 24, 2019
• Last Updated: December 1, 2021
• Results First Posted: March 4, 2020

Record last verified: 2021-11

Locations

US (27)