Knee OsteoarthritisPhase 1/2NCT01365260
Safety and Efficacy of an Injectable Medical Device to Treat Knee Osteoarthritis
A Phase 1/2 study testing MM-II and DurolaneTM in people with Knee Osteoarthritis, run by Moebius Medical Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether MM-II is effective in the treatment of osteoarthritis, in direct comparison with an approved hyaluronic acid preparation. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- MM-II and DurolaneTM
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Nov 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic unilateral knee tibiofemoral OA
- Radiographic evidence of knee OA of Kellgren-Lawrence Grade II or III in one or both knees on a recent 3 months time X-Ray
- Knee pain within the last 24 hours before assessment more than 40mm on VAS
- Pain on most days in the last month
Who cannot join
- Knee pain equal or more than 80mm on a 100mm VAS.
- Pain in the contra lateral knee; more than 30mm on a 100 VAS.
- Concomitant inflammatory joint disease (e.g. gout, rheumatoid arthritis, history of Reiter's syndrome, psoriatic arthritis and ankylosing spondylitis.
- Any condition that may interfere with the measure of pain in the targeted knee
- Concomitant meaningful synovial fluid effusion
- Post trauma OA
- Gross ligamentous instability of the knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Feasibility Controlled Study to Assess the Safety and Efficacy of MM-II, an Injectable Intraarticular Medical Device, Intended to the Treatment of Symptomatic Knee Osteoarthritis
The purpose of this study is to determine whether MM-II is effective in the treatment of osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.
Read the detailed description
Osteoarthritis (OA) is the commonest form of joint disease, characterized by articular cartilage degradation with an accompanying periarticular bone response and a synovial membrane inflammation. Clinical manifestations of OA in the knee include pain in and around the joint, stiffness of the joint after rest, crepitus on motion and limited joint. MM-II medical device was designed to reduce wear and lower friction in knees of osteoarthritis patients by creating a lubricating layer onto cartilage surfaces upon injection. The purpose of this study is to determine whether a medical device MM-II is effective in the treatment of osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.
- Conditions
- Knee Osteoarthritis
- Being tested
- MM-II, DurolaneTM
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM-IIDevice
Single intraarticular (knee) injection of MM-II
DurolaneTMDevice
Also called hyaluronic acid
Single intraarticular (knee) injection of DurolaneTM
| Study group | Role | What they receive |
|---|---|---|
| MM-II | Experimental | Not described Receives: Device: MM-II |
| DurolaneTM | Active comparator | hyaluronic acid Receives: Device: DurolaneTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with an acute inflammatory reaction in the injected knee
An acute inflammatory reaction in more than 5% of the participants will be considered as manifestation of treatment related intolerance
Measured: up to 7 days
Change from baseline in blood count
Measured: 3 days and 7 days
Number of participants with adverse events
Measured: Up to 90 days after the treatment
Secondary outcomes (6)
Maximum global pain in the target knee
Measured by Visual Analogue Scale for pain (VAS)
Measured: Days -21, 0, 1, 3, 7, 14, 30, 90th
The Western Ontario and McMaster University OA index (WOMAC)
Measured: Days 0, 7, 14, 30, 90
The patient global assessment of treatment by Likert-scale questionnaire
Measured: Days 0, 7, 14, 30, 90
The patients acceptance of symptoms state (PASS)
Measured: Days 7, 14, 30, 90
Omeract-ORASI responders index
Measured: Days 7, 14, 30
The number of tablets of rescue medications used between visits
Measured: During the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moebius Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonid (Arieh) Kandel, MD, Principal investigator, Hadassah Mount Scopus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365260
- Sponsor's protocol ID
- MM-002
- Other IDs
- 0196-11-HMO, HTA 5960
- Status last verified
- Dec 2012
- First submitted
- 31 May 2011
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Feasibility Controlled Study to Assess the Safety and Efficacy of MM-II, an Injectable Intraarticular Medical Device, Intended to the Treatment of Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01365260
- Acronym / sponsor ID
- MM-002
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Moebius Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether MM-II is effective in the treatment of osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.
Detailed description
Osteoarthritis (OA) is the commonest form of joint disease, characterized by articular cartilage degradation with an accompanying periarticular bone response and a synovial membrane inflammation. Clinical manifestations of OA in the knee include pain in and around the joint, stiffness of the joint after rest, crepitus on motion and limited joint. MM-II medical device was designed to reduce wear and lower friction in knees of osteoarthritis patients by creating a lubricating layer onto cartilage surfaces upon injection. The purpose of this study is to determine whether a medical device MM-II is effective in the treatment of osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MM-II | Experimental | Device: MM-II |
| DurolaneTM | Active comparator | Device: DurolaneTMhyaluronic acid |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic unilateral knee tibiofemoral OA
- Radiographic evidence of knee OA of Kellgren-Lawrence Grade II or III in one or both knees on a recent 3 months time X-Ray
- Knee pain within the last 24 hours before assessment more than 40mm on VAS
- Pain on most days in the last month
Key exclusion criteria (7 listed)
- Knee pain equal or more than 80mm on a 100mm VAS.
- Pain in the contra lateral knee; more than 30mm on a 100 VAS.
- Concomitant inflammatory joint disease (e.g. gout, rheumatoid arthritis, history of Reiter's syndrome, psoriatic arthritis and ankylosing spondylitis.
- Any condition that may interfere with the measure of pain in the targeted knee
- Concomitant meaningful synovial fluid effusion
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 |
|---|---|---|
| MM-IISingle intraarticular (knee) injection of MM-II | Device | MM-II |
| DurolaneTMAlso: hyaluronic acidSingle intraarticular (knee) injection of DurolaneTM | Device | DurolaneTM |
Primary outcome
Number of participants with an acute inflammatory reaction in the injected knee
Time frame: up to 7 days
An acute inflammatory reaction in more than 5% of the participants will be considered as manifestation of treatment related intolerance
Change from baseline in blood count
Time frame: 3 days and 7 days
Number of participants with adverse events
Time frame: Up to 90 days after the treatment
6 secondary outcomes
Maximum global pain in the target knee
Time frame: Days -21, 0, 1, 3, 7, 14, 30, 90th
The Western Ontario and McMaster University OA index (WOMAC)
Time frame: Days 0, 7, 14, 30, 90
The patient global assessment of treatment by Likert-scale questionnaire
Time frame: Days 0, 7, 14, 30, 90
The patients acceptance of symptoms state (PASS)
Time frame: Days 7, 14, 30, 90
Omeract-ORASI responders index
Time frame: Days 7, 14, 30
The number of tablets of rescue medications used between visits
Time frame: During the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
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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.
Leonid (Arieh) Kandel, MD principal investigator
Hadassah Mount Scopus Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MM-II and DurolaneTM in people with Knee Osteoarthritis, run by Moebius Medical Ltd. at 1 site in Israel.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with an acute inflammatory reaction in the injected knee (time frame: up to 7 days). The study lists 3 primary outcomes in all. 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 5 Dec 2012.