Osteoarthritis of First Metatarsalphalangeal JointPhase 3NCT00969969
A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe
A Phase 3 study testing Arthrodesis and Cartiva in people with Osteoarthritis of First Metatarsalphalangeal Joint, run by Cartiva, Inc. at 12 sites in 2 countries.
Trial summary
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe. 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?
- Arthrodesis and Cartiva
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Aug 2009to Jul 2016
- 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
- ≥ 18 years of age
- Osteoarthritis of the first metatarsophalangeal joint and is a candidate for arthrodesis
- Presence of good bone stock
- Capable of completing self-administered questionnaires
Who cannot join
- < 18 years of age
- Osteoarthritis of the first metatarsophalangeal joint, though is not a candidate for arthrodesis
- Active bacterial infection of the foot
- Additional ipsilateral limb (hip, knee, ankle, or foot) pathology that requires active treatment (surgery or brace)
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada6 sites
University of Calgary
Calgary, Alberta, T2N 4N1
University of Alberta
Edmonton, Alberta
Horizon Health Network
Fredericton, New Brunswick, E3B 5N5
Queen Elizabeth Science Centre
Halifax, Nova Scotia, B3H 3A7
St. Michael's Hospital
Toronto, Ontario, M5C 1R6
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
United Kingdom6 sites
Frimley Park Hospital - Surrey Foot and Ankle Clinic
Frimley, Camberley, GU16 7UJ
Royal Surrey County Hospital
Guildford, Surrey, GU2 5XX
Northern General Hospital NHS Trusts - Sheffield Orthopaedics
Sheffield, South Yorkshire, S5 7AU
Torbay Hospital
South Devon, Torquay, TQ2 7AA
Royal National Orthopaedic Hospital - Stanmore Foot & Ankle Clinic
Stanmore, Middlesex, HA7 4LP
St. George's Hospital
Tooting, London, SW17 0QT
About this study
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.
- Being tested
- Arthrodesis, 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.
ArthrodesisDevice
arthrodesis using screws and/or a plate
CartivaDevice
Cartiva Synthetic Cartilage Implant
| Study group | Role | What they receive |
|---|---|---|
| Arthrodesis | Active comparator | Fusion Receives: Device: Arthrodesis |
| Cartiva | Experimental | Synthetic Cartilage Implant Receives: Device: Cartiva |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS, FAAM, Safety
The individual components of the primary outcome measures will be Visual Analog Scale (VAS) Pain, Foot and Ankle Ability Measure (FAAM) Sports sub-scale score and absence of key safety issues.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2016
- Study completionJul 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cartiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Judith Baumhauer, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969969
- Sponsor's protocol ID
- PTC-0031
- Status last verified
- Nov 2016
- First submitted
- 1 Sep 2009
- Last updated
- 15 Nov 2016
- 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 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe
- ClinicalTrials.gov ID
- NCT00969969
- Acronym / sponsor ID
- PTC-0031
- 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
- 236 participants (actual)
- Lead sponsor
- Cartiva, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Sep 2009 (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.
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthrodesis | Active comparator | Device: ArthrodesisFusion |
| Cartiva | Experimental | Device: CartivaSynthetic Cartilage Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- Osteoarthritis of the first metatarsophalangeal joint and is a candidate for arthrodesis
- Presence of good bone stock
- Capable of completing self-administered questionnaires
Key exclusion criteria (4 listed)
- < 18 years of age
- Osteoarthritis of the first metatarsophalangeal joint, though is not a candidate for arthrodesis
- Active bacterial infection of the foot
- Additional ipsilateral limb (hip, knee, ankle, or foot) pathology that requires active treatment (surgery or brace)
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 |
|---|---|---|
| Arthrodesisarthrodesis using screws and/or a plate | Device | Arthrodesis |
| CartivaCartiva Synthetic Cartilage Implant | Device | Cartiva |
Primary outcome
VAS, FAAM, Safety
Time frame: up to 2 years
The individual components of the primary outcome measures will be Visual Analog Scale (VAS) Pain, Foot and Ankle Ability Measure (FAAM) Sports sub-scale score and absence of key safety issues.
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 15 Nov 2016.
- 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 principal investigator
University of Rochester
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arthrodesis and Cartiva in people with Osteoarthritis of First Metatarsalphalangeal Joint, run by Cartiva, Inc. at 12 sites in 2 countries.
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 4 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 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, United Kingdom. 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 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?
VAS, FAAM, Safety (time frame: up to 2 years). 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 15 Nov 2016; AzTrials last refreshed its copy on 6 Nov 2026.