Osteoarthritis of the HipPhase 3NCT02698865
The MONOVISC Hip Osteoarthritis Study
A Phase 3 study testing MONOVISC and Saline in people with Osteoarthritis of the Hip, run by DePuy Mitek at 27 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoarthritis of the Hip
- What is being tested?
- MONOVISC and Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 27 sitesUnited States
- Study dates
- 1 Jan 2016to 24 Jun 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
MedSport - University of Michigan
Ann Arbor, Michigan, 48106
Texas Orthopedic Specialists
Bedford, Texas, 76021
Emory Sports Complex
Brookhaven, Georgia, 30329
University of North Carolina
Chapel Hill, North Carolina, 27599
OrthoCarolina Sports Medicine Center
Charlotte, North Carolina, 28207
University of Virginia
Charlottesville, Virginia, 22903
Professional Orthopedics
Cherry Hill, New Jersey, 08034
University of Colorado - Denver
Denver, Colorado, 80111
Denver Hip and Knee
Denver, Colorado, 80134
Iowa Orthopedic Center
Des Moines, Iowa, 50314
CORE Orthopedic Medical Center
Encinitas, California, 92024
Sanford Health
Fargo, North Dakota, 58103
Cleveland Clinic
Garfield Heights, Ohio, 44125
Houston Methodist
Houston, Texas, 77030
Inov8 Orthopaedics
Houston, Texas, 77043
National Sports Medicine Institute
Lansdowne Town Center, Virginia, 20176
OrthoVirginia
Lynchburg, Virginia, 24501
Rothman Institute
Media, Pennsylvania, 19063
Center for Arthritis and Rheumatic Diseases
Miami, Florida, 33173
Hospital for Special Surgery
New York, New York, 10021
Columbia Medical Center
New York, New York, 10032
Sports Medicine North
Peabody, Massachusetts, 01960
Integral Rheumatology & Immunology Specialists
Plantation, Florida, 33324
Eisenhower Medical Center/Desert Orthopedic Center
Rancho Mirage, California, 92270
San Antonio Orthopaedic Group
San Antonio, Texas, 78216
Tucson Orthopedic Institute
Tucson, Arizona, 85712
Southern California Orthopedic Institute
Van Nuys, California, 91405
About this study
Official title: 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).
Read the 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
- Being tested
- MONOVISC, Saline
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MONOVISCDevice
Two (2) intra-articular injections of 4 ml MONOVISC, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy)
SalineDevice
Two (2) intra-articular injections of 4 ml saline, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy)
| Study group | Role | What they receive |
|---|---|---|
| MONOVISC | Experimental | MONOVISC High Molecular Weight Hyaluronan Receives: Device: MONOVISC |
| Saline | Placebo comparator | Physiologic saline Receives: Device: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, Day 14, 28, 60 and 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study start1 Jan 2016
- Primary completion15 Mar 2019
- Study completion24 Jun 2019
Why it stopped: The results of the interim analysis indicate the futility criterion have been met, therefore enrollment was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of the HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Mitek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brooks J Story, PhD, Study director, DePuy Synthes Mitek Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698865
- Sponsor's protocol ID
- 15-MVH-01
- Status last verified
- Nov 2021
- First submitted
- 25 Feb 2016
- Last updated
- 1 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study Comparing Two Injections of MONOVISC to Two Injections of Saline in Patients With Osteoarthritis of the Hip
- ClinicalTrials.gov ID
- NCT02698865
- Acronym / sponsor ID
- 15-MVH-01
- Conditions
- Osteoarthritis of the Hip
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The results of the interim analysis indicate the futility criterion have been met, therefore enrollment was terminated.
- Enrolment
- 220 participants (actual)
- Lead sponsor
- DePuy MitekIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Posted 4 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MONOVISC | Experimental | Device: MONOVISCMONOVISC High Molecular Weight Hyaluronan |
| Saline | Placebo comparator | Device: SalinePhysiologic saline |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MONOVISCTwo (2) intra-articular injections of 4 ml MONOVISC, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy) | Device | MONOVISC |
| SalineTwo (2) intra-articular injections of 4 ml saline, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy) | Device | Saline |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brooks J Story, PhD study director
DePuy Synthes Mitek Sports Medicine
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MONOVISC and Saline in people with Osteoarthritis of the Hip, run by DePuy Mitek at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.