The MONOVISC Hip Osteoarthritis Study

NCT ID: NCT02698865

Last Updated: 2021-12-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-06-24

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.

Conditions

Osteoarthritis of the Hip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MONOVISC

MONOVISC High Molecular Weight Hyaluronan

Group Type: EXPERIMENTAL

MONOVISC

Intervention Type: DEVICE

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

Saline

Physiologic saline

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DEVICE

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

Interventions

MONOVISC

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

Intervention Type: DEVICE

Saline

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Mitek

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brooks J Story, PhD

Role: STUDY_DIRECTOR

DePuy Synthes Mitek Sports Medicine

Locations

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

National Sports Medicine Institute

Lansdowne Town Center, Virginia, United States

OrthoVirginia

Lynchburg, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

15-MVH-01

Identifier Type: -

Identifier Source: org_study_id