The MONOVISC Hip Osteoarthritis Study

November 29, 2021 updated by: DePuy Mitek

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 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.
Baseline and Day 180

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 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.
Baseline, Day 14, 28, 60 and 120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DePuy Mitek

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Brooks J Story, PhD, DePuy Synthes Mitek Sports Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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