- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04204083
MONOVISC for Hip Joint Pain Relief
A Prospective Study of a Single Injection Cross-linked Sodium Hyaluronate (MONOVISC) to Provide Symptomatic Relief of Osteoarthritis of Hip Joint
Study Overview
Detailed Description
This is a prospective, post market clinical follow-up (PMCF) multi-center, open-label study to evaluate the residual risk of injections of MONOVISC for relief of pain in patients with a diagnosis of an osteoarthritic hip joint.
The subjects in this study will be patients with a diagnosis of osteoarthritic (OA) joint who the investigator determines are appropriate candidates for treatment with a viscoelastic injection of MONOVISC.
Up to 25 subjects will be enrolled at up to 20 investigational sites in the EU. Subject participation will last approximately 6 Months, with visits scheduled at Screening, Baseline, 1 month, 3 month and 6 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 years or older
- Body Mass Index (BMI) ≤ 35 kg/m2
- Diagnosis of symptomatic osteoarthritic joint in the index joint (Kellgren-Lawrence grade I to III) to be treated with MONOVISC injection.
- Failed conservative treatment for joint osteoarthritis.
- NRS pain on walking ≥4 and ≤ 9 in index joint.
- Subject must be willing to abstain from other treatments of the index joint for the duration of the study.
- Subject is willing to discontinue all analgesics including NSAIDs, except acetaminophen/paracetamol, at least seven days before the treatment injection and through the completion of the study.
- Subject is willing to use only acetaminophen/paracetamol (up to a maximum of 4.0 grams per day per the package insert) for the treatment of joint pain for the duration of the study. At least forty-eight hours prior to the Baseline Visit and each follow-up visit, the subject is willing to discontinue use of acetaminophen/paracetamol.
- Subject is willing to maintain a stable dose of oral glucosamine and/or chondroitin sulfate products throughout the study, if taken prior to signing the informed consent form (ICF).
- Able and willing to provide signed informed consent.
Exclusion Criteria:
- History of hypersensitivity to any of the ingredients in the hyaluronan
- Infection or skin disease in the area of the injection site or index joint
- NRS pain on walking > 3 in the contralateral joint
- NRS pain on walking > 3 in the ipsilateral knee or ankle
- Subject received an injection of Hyaluronic Acid (HA) and/or steroid in either joint within 6 months of signing the informed consent form (ICF). A subject will be excluded if they are planning to receive an HA or steroid injection (other than the study injection) in either joint during the course of this study.
- Known inflammatory or autoimmune disorders (including rheumatoid arthritis, gout), or other pre-existing medical conditions that, in the opinion of the investigator, could impact treatment of the index joint or affect the ability of the subject to accurately complete the study questionnaires and comply with the study requirements.
- Subject is taking medications at the time of signing the ICF which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study.
- Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical (excluded in index joint only) corticosteroid prior 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index joint is allowed.
- Significant trauma to the index hip within 26 weeks of screening
- Chronic use of narcotics or cannabis.
- Ligament instability or tear in index joint.
- Diagnosis of fibromyalgia
- Diagnosis of osteonecrosis in index joint
- Subject has significant varus or valgus deformity greater than 10 degrees in either knee.
- Subject requires consistent use of an assistive device (e.g. wheelchair, walker, etc.) Occasional use of a cane is acceptable.
- Uncontrolled diabetes with HbA1c of >7%.
- Subject is a woman who is pregnant or breastfeeding at the Screening Visit or a woman of child bearing potential who refuses to use effective contraception during the course of the study.
- Subject is receiving or in litigation for worker's compensation.
- 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Monovisc
|
A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose in a 5-mL glass syringe.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Index joint Numerical Rating Scale (NRS 0 - 10 0 No Pain, 10 Worst Pain) pain on walking
Time Frame: From baseline to 6 months
|
Reduction of index joint Numerical Rating Scale (NRS) pain on walking from baseline to 6 Months post injection.
|
From baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Patient Global Assessment (PGA) (0-10 0 No Pain, 10 Worst Pain)
Time Frame: From baseline to 6 months
|
Improvement in Patient Global Assessment (PGA) from baseline to 6 months post injection.
|
From baseline to 6 months
|
Improvement in Lequesne Hip index (0-14, 0 No Handicap 14 Extreme Handicap)
Time Frame: From baseline to 3 months
|
Improvement in Lequesne Hip index from baseline to 6 months post injection.
|
From baseline to 3 months
|
OMERACT-OARSI Responder Rate in index joint
Time Frame: From baseline to 6 months
|
OMERACT-OARSI responder rate in index joint at 6 months post injection.
|
From baseline to 6 months
|
Reduction in Medication usage
Time Frame: From baseline to 6 months
|
Reduction in Medication usage from baseline to 6 months post injection
|
From baseline to 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MON 18-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Osteoarthritis, Hip
-
Istituto Ortopedico RizzoliRecruiting
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
CHU de ReimsCompleted
-
Royan InstituteCompletedHip OsteoarthritisIran, Islamic Republic of
-
Daiichi Sankyo, Inc.TerminatedSymptomatic Hip OsteoarthritisFrance
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Oxford University Hospitals NHS TrustCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthroplasty | Hip ArthroplastyUnited Kingdom
-
University of ArkansasCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthritis | Hip ArthritisUnited States
-
Johan KarrholmCompletedPrimary Osteoarthritis of Hip Nos | Secondary Osteoarthritis of Hip
-
Lawson Health Research InstituteCompletedHip Osteoarthritis | Hip ArthroplastyCanada
Clinical Trials on Monovisc
-
Anika Therapeutics, Inc.Completed
-
DePuy MitekTerminated
-
Anika Therapeutics, Inc.Completed
-
Rothman Institute OrthopaedicsSean McMillan, DOUnknownOsteoarthritis
-
Anika Therapeutics, Inc.Completed
-
Andrews Research & Education FoundationActive, not recruitingKnee OsteoarthritisUnited States
-
Anika Therapeutics, Inc.CompletedOsteoarthritisCanada, United States
-
October 6 UniversityUnknown
-
University of ArkansasCompleted
-
Pharmascience Inc.CompletedOsteoarthritis, KneeCanada