Osteoarthritis of First Metatarsalphalangeal JointPhase 3MOTIONNCT02978573
Post Approval Study to Evaluate the Effectiveness and Safety of Cartiva Implant in the Treatment of OA of the Great Toe
A Phase 3 study testing Cartiva in people with Osteoarthritis of First Metatarsalphalangeal Joint, run by Cartiva, Inc..
Trial summary
Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant established by the pivotal trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of First Metatarsalphalangeal Joint
- What is being tested?
- Cartiva
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to 27 Apr 2018
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have been treated with Cartiva under MOTION study protocol PTC-0031; and,
- Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the IRB/Ethics Committee for long-term follow-up.
Who cannot join
- Subjects who underwent a secondary surgical intervention to have the Cartiva implant removed during the 24-month time period of participation in the MOTION study.
About this study
Official title: A Post Approval Study to Evaluate the Safety and Effectiveness of Cartiva Implant in the Treatment of First Metatarsophalangeal Joint Osteoarthritis as Compared to a Control
Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant established by the pivotal trial.
Read the detailed description
As part of the Conditions of Approval of Cartiva SCI for the treatment of first MTP osteoarthritis, the Food and Drug Administration (FDA) requires additional long term data to evaluate the long term safety and effectiveness of Cartiva including the durability and survivorship of the implant. This Post-Approval Study (PAS) addendum is intended to supplement the initial 24 months follow up period and provide additional long term safety and effectiveness data on Cartiva
- Being tested
- Cartiva
- Keywords
- First MTP Joint, Hallux Rigidus, Hallux Limitus, Cartilage Replacement, Osteoarthritis, First MTP Joint Osteoarthritis, Big Toe Pain
- Medical subject headings
- Hallux Rigidus, Hallux Limitus, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CartivaDevice
Cartiva Synthetic Cartilage Implant
| Study group | Role | What they receive |
|---|---|---|
| Cartiva | Experimental | Cartiva Synthetic Cartilage Implant Receives: Device: Cartiva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long Term Safety of the Cartiva Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise
- Durability of the implant over the longer term. This will be addressed using survival analysis starting at Month 24 to determine the rate of implant removals among devices that survived to Month 24. A complementary survival analysis starting at index surgery to end of study will also be performed.
- There are no unanticipated safety concerns that arise after Month 24 up to 5 years. This will be addressed by a) determining the incidence of serious device-related adverse events per year and overall from Month 24 to Year 5; and b) summarizing device-related radiographic complications1 over time from Month 24 to Year 5. Note that this analysis will address both device and procedure related complications and serious device-related adverse events whether observed previously in the 24 month follow up portion of the study or encountered for this first time during the extended follow-up period.
Measured: 5 year
Secondary outcomes (3)
Pain Scale (VAS)
Visual Analog Scale (VAS) Pain
Measured: 5 year
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL)
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living scores
Measured: 5 year
Foot and Ankle Ability Measure (FAAM) Sports
Foot and Ankle Ability Measure (FAAM) Sports scores
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startOct 2016
- Primary completion27 Apr 2018
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of First Metatarsalphalangeal JointStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cartiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Judith Baumhauer, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978573
- Sponsor's protocol ID
- PTC-0031 (PAS)
- Acronym
- MOTION
- Status last verified
- Mar 2019
- First submitted
- 11 Nov 2016
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Approval Study to Evaluate the Safety and Effectiveness of Cartiva Implant in the Treatment of First Metatarsophalangeal Joint Osteoarthritis as Compared to a Control
- ClinicalTrials.gov ID
- NCT02978573
- Acronym / sponsor ID
- MOTION / PTC-0031 (PAS)
- Keywords
- First MTP Joint, Hallux Rigidus, Hallux Limitus, Cartilage Replacement, Osteoarthritis, First MTP Joint Osteoarthritis, Big Toe Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Cartiva, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 1 Dec 2016 (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.
Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant established by the pivotal trial.
Detailed description
As part of the Conditions of Approval of Cartiva SCI for the treatment of first MTP osteoarthritis, the Food and Drug Administration (FDA) requires additional long term data to evaluate the long term safety and effectiveness of Cartiva including the durability and survivorship of the implant. This Post-Approval Study (PAS) addendum is intended to supplement the initial 24 months follow up period and provide additional long term safety and effectiveness data on Cartiva
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cartiva | Experimental | Device: CartivaCartiva Synthetic Cartilage Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject must have been treated with Cartiva under MOTION study protocol PTC-0031; and,
- Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the IRB/Ethics Committee for long-term follow-up.
Key exclusion criteria (1 listed)
- Subjects who underwent a secondary surgical intervention to have the Cartiva implant removed during the 24-month time period of participation in the MOTION study.
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 |
|---|---|---|
| CartivaCartiva Synthetic Cartilage Implant | Device | Cartiva |
Primary outcome
Long Term Safety of the Cartiva Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise
Time frame: 5 year
1. Durability of the implant over the longer term. This will be addressed using survival analysis starting at Month 24 to determine the rate of implant removals among devices that survived to Month 24. A complementary survival analysis starting at index surgery to end of study will also be performed. 2. There are no unanticipated safety concerns that arise after Month 24 up to 5 years. This will be addressed by a) determining the incidence of serious device-related adverse events per year and overall from Month 24 to Year 5; and b) summarizing device-related radiographic complications1 over time from Month 24 to Year 5. Note that this analysis will address both device and procedure related complications and serious device-related adverse events whether observed previously in the 24 month follow up portion of the study or encountered for this first time during the extended follow-up period.
3 secondary outcomes
Pain Scale (VAS)
Time frame: 5 year
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL)
Time frame: 5 year
Foot and Ankle Ability Measure (FAAM) Sports
Time frame: 5 year
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 22 Mar 2019.
- Individual participant dataSharing planned: No
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.
Judith Baumhauer, MD principal investigator
University of Rochester
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cartiva in people with Osteoarthritis of First Metatarsalphalangeal Joint, run by Cartiva, Inc..
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 2 inclusion and 1 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 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
Long Term Safety of the Cartiva Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise (time frame: 5 year). 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 22 Mar 2019.