The MONOVISC Hip Osteoarthritis Study

Osteoarthritis of the Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02698865
• Other study ID #: 15-MVH-01
• Status: Terminated
• Phase: Phase 3
• Start date: January 1, 2016
• Est. completion date: June 24, 2019

Study information

• Verified date: November 2021
• Source: DePuy Mitek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 220
• Est. completion date: June 24, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Hip
• Osteoarthritis, Hip

Intervention

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

Locations

Country	Name	City	State
United States	MedSport - University of Michigan	Ann Arbor	Michigan
United States	Texas Orthopedic Specialists	Bedford	Texas
United States	Emory Sports Complex	Brookhaven	Georgia
United States	University of North Carolina	Chapel Hill	North Carolina
United States	OrthoCarolina Sports Medicine Center	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Professional Orthopedics	Cherry Hill	New Jersey
United States	Denver Hip and Knee	Denver	Colorado
United States	University of Colorado - Denver	Denver	Colorado
United States	Iowa Orthopedic Center	Des Moines	Iowa
United States	CORE Orthopedic Medical Center	Encinitas	California
United States	Sanford Health	Fargo	North Dakota
United States	Cleveland Clinic	Garfield Heights	Ohio
United States	Houston Methodist	Houston	Texas
United States	Inov8 Orthopaedics	Houston	Texas
United States	National Sports Medicine Institute	Lansdowne Town Center	Virginia
United States	OrthoVirginia	Lynchburg	Virginia
United States	Rothman Institute	Media	Pennsylvania
United States	Center for Arthritis and Rheumatic Diseases	Miami	Florida
United States	Columbia Medical Center	New York	New York
United States	Hospital for Special Surgery	New York	New York
United States	Sports Medicine North	Peabody	Massachusetts
United States	Integral Rheumatology & Immunology Specialists	Plantation	Florida
United States	Eisenhower Medical Center/Desert Orthopedic Center	Rancho Mirage	California
United States	San Antonio Orthopaedic Group	San Antonio	Texas
United States	Tucson Orthopedic Institute	Tucson	Arizona
United States	Southern California Orthopedic Institute	Van Nuys	California

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Mitek

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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