OsteoarthritisGRIPNCT02391506
Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis
A study testing Cartiva in people with Osteoarthritis, run by Cartiva, Inc. at 9 sites in 2 countries.
Trial summary
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the CMC joint in the hand. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Cartiva
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 29 Jul 2015to 5 Mar 2019
- Phase
- Interventional
- 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 carpometacarpal joint
- Presence of good bone stock without the need for bone graft
- Capable of completing self-administered questionnaires
Who cannot join
- < 18 years of age
- Active bacterial infection of the hand
- Previous CMC implant and/or surgery to the affected joint to be treated that would prevent implantation and fixation of Cartiva® SCI for CMC
- Patient has osteoarthritis of the scaphotrapeziotrapezoidal (STT) joint in the hand to be treated
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United Kingdom5 sites
Woodend Hospital
Aberdeen, Scotland, AB15 6XS
Royal United Hospital
Bath, BA1 3NG
Royal Derby Hospital
Derby, DE22 3NE
South Tees Hospital
Middlesbrough, TS 4 3BW
Queen Alexandra Hospital
Portsmouth, PO6 3LY
Canada4 sites
University of Calgary
Calgary, Alberta
QEII Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
Sunnybrook Health Sciences Centre
Toronto, Ontario
UBC, Division of Plastic Surgery
Vancouver, British Columbia, V5Z1M9
About this study
Official title: A Prospective Study to Evaluate the Safety and Effectiveness of the Cartiva® Synthetic Cartilage Implant for CMC in the Treatment of First Carpometacarpal Joint Osteoarthritis
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the CMC joint in the hand.
Read the detailed description
This is a prospective traditional feasibility study evaluating Cartiva® SCI for CMC for the treatment of first carpometacarpal joint osteoarthritis.The objectives of this clinical study are to evaluate the safety and effectiveness of Cartiva® SCI for CMC in terms of pain relief and improvement of joint function in the treatment of first CMC OA and to evaluate Cartiva® SCI for CMC device performance in order to establish the parameters for a pivotal trial. Follow up visits will occur at the following time points after the surgical procedure: 14 days, 42 days, 90 days, 180 days, 1 year and 2 year.
Data will be summarized using descriptive statistics. Continuous variables will be summarized using the number of observations, mean, standard deviation, median, and range as appropriate. Categorical values will be summarized using the number of observations and percentages as appropriate. Chi-square or Fisher exact tests will be used for comparisons of categorical data. Paired t-tests will used for the comparisons of continuous data. For statistical testing, an alpha of 0.05 is used as an acceptance standard and all testing are conducted as two tailed. Also, 95% confidence intervals for mean values or proportion values will be provided as appropriate.
Since this is a feasibility study and no formal hypothesis is to be tested, p-values will be reported without adjustment for multiple comparisons. All analyses will be conducted using SAS version 9.1 or later.
- Conditions
- Osteoarthritis
- Being tested
- Cartiva
- Keywords
- First CMC joint, Osteoarthritis, Cartilage Replacement, First CMC Joint Osteoarthritis, Damaged Articular Surface
- Medical subject headings
- 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 | Synthetic Cartilage Implant Receives: Device: Cartiva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured by the Visual Analog Scale (VAS) scale
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start29 Jul 2015
- Primary completion5 Mar 2019
- Study completion5 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cartiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391506
- Sponsor's protocol ID
- PTC-0116
- Acronym
- GRIP
- Status last verified
- Mar 2019
- First submitted
- 9 Mar 2015
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Prospective Study to Evaluate the Safety and Effectiveness of the Cartiva® Synthetic Cartilage Implant for CMC in the Treatment of First Carpometacarpal Joint Osteoarthritis
- ClinicalTrials.gov ID
- NCT02391506
- Acronym / sponsor ID
- GRIP / PTC-0116
- Conditions
- Osteoarthritis
- Keywords
- First CMC joint, Osteoarthritis, Cartilage Replacement, First CMC Joint Osteoarthritis, Damaged Articular Surface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cartiva, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2015 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 18 Mar 2015 (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 CMC joint in the hand.
Detailed description
This is a prospective traditional feasibility study evaluating Cartiva® SCI for CMC for the treatment of first carpometacarpal joint osteoarthritis.The objectives of this clinical study are to evaluate the safety and effectiveness of Cartiva® SCI for CMC in terms of pain relief and improvement of joint function in the treatment of first CMC OA and to evaluate Cartiva® SCI for CMC device performance in order to establish the parameters for a pivotal trial. Follow up visits will occur at the following time points after the surgical procedure: 14 days, 42 days, 90 days, 180 days, 1 year and 2 year.
Data will be summarized using descriptive statistics. Continuous variables will be summarized using the number of observations, mean, standard deviation, median, and range as appropriate. Categorical values will be summarized using the number of observations and percentages as appropriate. Chi-square or Fisher exact tests will be used for comparisons of categorical data. Paired t-tests will used for the comparisons of continuous data. For statistical testing, an alpha of 0.05 is used as an acceptance standard and all testing are conducted as two tailed. Also, 95% confidence intervals for mean values or proportion values will be provided as appropriate.
Since this is a feasibility study and no formal hypothesis is to be tested, p-values will be reported without adjustment for multiple comparisons. All analyses will be conducted using SAS version 9.1 or later.
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: 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 carpometacarpal joint
- Presence of good bone stock without the need for bone graft
- Capable of completing self-administered questionnaires
Key exclusion criteria (4 listed)
- < 18 years of age
- Active bacterial infection of the hand
- Previous CMC implant and/or surgery to the affected joint to be treated that would prevent implantation and fixation of Cartiva® SCI for CMC
- Patient has osteoarthritis of the scaphotrapeziotrapezoidal (STT) joint in the hand to be treated
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
Pain measured by the Visual Analog Scale (VAS) scale
Time frame: 1 year follow up
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
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cartiva in people with Osteoarthritis, run by Cartiva, Inc. at 9 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 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, Canada. 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.
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?
Pain measured by the Visual Analog Scale (VAS) scale (time frame: 1 year follow up). 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.