OsteoarthritisGRIP 2NCT03247439
Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Compared to LRTI (GRIP 2)
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 first CMC joint in the hand compared to LRTI. Read more about this study
- Who is it for?
- Ages 22 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
- 74 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 22 Dec 2017to Mar 2024
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 22 years of age
- Refractory to conservative non-operative standard of care treatment for first CMC OA lasting for at least 6 months that requires surgical intervention
- Eaton classification stage II or III OA of the first CMC joint based on X-rays taken within 6 months of the Operative date and evidence of first CMC joint OA based on subjective review of associated clinical symptoms
- Preoperative VAS Pain score of ≥ 40 in the treated hand
- Preoperative 11 question QuickDASH score of ≥ 20
- Presence of good bone stock - i.e., no need for bone graft
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- Capable of completing self-administered questionnaires
- Be willing and able to return for all study-related follow up procedures
- Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the IRB/REB/Ethics Committee
Who cannot join
- Active systemic infection
- Active infection at the site of surgery
- Previous CMC implant, trapeziectomy, or LRTI to the affected joint to be treated
- Inflammatory arthropathy and/or diagnosis of grout
- History of or current diagnosis of rheumatoid arthritis
- Any significant bone loss, avascular necrosis, or cyst > 8mm of the supporting bone structure
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- Eaton classification stage IV advanced OA of the first CMC joint based on X-rays taken within 6 months of the Operative date
- Physical conditions that would tend to eliminate adequate implant support (e.g., inadequate cortical bone stock of at least 2mm circumferentially insufficient quality or quantity of bone resulting from cancer, congenital dislocation, or osteoporosis), systemic and metabolic disorders leading to progressive deterioration of bone (e.g., cortisone therapies or immunosuppressive therapies), and/or tumors and/or cysts of the supporting bone structures
- OA of the scaphotrapeziotrapezoidal (STT) joint based on radiographic assessment in the hand to be treated
- Any disease, including uncontrolled diabetes mellitus, which is clinically known to impact wound healing ability
- Known or suspected allergic reaction to polyvinyl alcohol
- Patient is on chronic anticoagulation due to a bleeding disorder or has taken anticoagulants within 3 days prior to surgery
- Diagnosed with cancer in the last two years and received treatment with chemotherapy or received radiation to the upper extremity to be treated with Cartiva
- Any medical condition that makes the subject unsuitable for inclusion in the study, including, but not limited to, patients with a diagnosis of concomitant injury that may interfere with healing; patients with clinically significant renal, hepatic, cardiac, endocrine, hematologic, autoimmune or any systemic disease or systemic infection which may make interpretation of the results difficult; patients who have undergone systemic administration within 30 days prior to implantation of any type of corticosteroid in the thumb, antineoplastic, immunostimulating or immunosuppressive agents
- Have participated in any other investigational or invasive clinical trial within the last three months, and will not participate in any other investigational or invasive clinical trial during this study
- Co-morbidity that reduces life expectancy to less than 12 months
- If female, be pregnant, planning to become pregnant during the course of the study, breast-feeding, or if childbearing age, is not using contraception
- Current or recent history of substance abuse (e.g., recreational drugs, narcotics, or alcohol) requiring intervention
- Is a prisoner or ward of the state
- Is unable to meet the treatment and follow up protocol requirements
- Is being compensated under workers' compensation or are currently involved in litigation that is related to the musculoskeletal system
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States5 sites
Georgia Hand, Shoulder & Elbow
Atlanta, Georgia, 30309
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46202
Hospital for Specialty Surgery
New York, New York, 10021
University of Rochester
Rochester, New York, 14642
University of California, San Diego
San Diego, California, 92093
United Kingdom4 sites
Royal Derby Hospital
Derby, Derbyshire, DE22 3NE
Dorset County Hospital
Dorchester, Dorset, DT2 8DH
South Tees Hospitals
Middlesbrough, North Yorkshire, TS4 3BW
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
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 as Compared to a Ligament Reconstruction Tendon Interposition (LRTI) Comparator
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the first CMC joint in the hand compared to LRTI.
Read the detailed description
This is a prospective, multicenter study with one treatment arm. Comparisons will be made to a performance target defined by subtracting a non-inferiority margin of 0.05 from an expected standard of care success rate of 0.55. The active treatment arm will receive a Cartiva® SCI for CMC.
A total of 74 subjects will be enrolled into the pivotal study.
Follow up visits will occur at the following time points after the surgical procedure: 2 week, 6 week, 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year.
- Conditions
- Osteoarthritis
- Being tested
- Cartiva
- Keywords
- CMC Joint, Osteoarthritis, Cartilage Replacement, First CMC Joint Osteoarthritis, Damaged Articular Surface, LRTI, Ligament Reconstruction Tendon Interposition
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CartivaDevice
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
Success criteria: ≥ 30% VAS decrease at 12 months. Visual Analog Scale (VAS) Pain score will be obtained from the subject for pain in the treated hand by completing a CRF, which has a 100 mm horizontal line on it, with the left end indicating that the subject has no pain and the right end of the line indicating a lot of pain. The subject will be instructed to place a mark on the horizontal line to rate the average pain in the treated thumb joint over the past week. The designated site staff will use a metric ruler to measure the markings made by the subject on the VAS to determine the VAS score.
Measured: 1 year
Function measured by QuickDASH
Success criteria: ≥ 15.9 point decrease at 12 months. QuickDASH functional score will be obtained from the subject. The QuickDASH, the shortened version of the DASH (Disabilities of the Arm, Shoulder, and Hand) Outcomes Measures, is a region-specific, self-reported questionnaire that uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. Subjects are asked to circle the appropriate response to each question based on their condition in the past week.
Measured: 1 year
Radiographic Findings
Success criteria: Freedom from radiographic failures post-surgery through 12 months. Radiographic failures are defined as device dislocation, device fragmentation and/or development of avascular necrosis.
Measured: 1 year
Key Subsequent Secondary Surgical Interventions (SSSIs)
Success criteria: Freedom from Subsequent Secondary Surgical Interventions (SSSIs) through 12 months. SSSIs are defined as revisions, removals, reoperations, and/or supplemental fixations.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start22 Dec 2017
- Primary completion30 Oct 2020
- Study completionMar 2024 (estimated)
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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cartiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Wolfe, MD, Principal investigator, Hospital for Special Surgery, New YorkChristopher Bainbridge, MB ChB, FRCSEd, CCST, Principal investigator, Royal Derby Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247439
- Sponsor's protocol ID
- PTC-0290
- Acronym
- GRIP 2
- Status last verified
- Dec 2020
- First submitted
- 4 Aug 2017
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. 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 as Compared to a Ligament Reconstruction Tendon Interposition (LRTI) Comparator
- ClinicalTrials.gov ID
- NCT03247439
- Acronym / sponsor ID
- GRIP 2 / PTC-0290
- Conditions
- Osteoarthritis
- Keywords
- CMC Joint, Osteoarthritis, Cartilage Replacement, First CMC Joint Osteoarthritis, Damaged Articular Surface, LRTI, Ligament Reconstruction Tendon Interposition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Cartiva, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- Mar 2024 (estimated)
- First posted
- 11 Aug 2017 (actual)
- 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 first CMC joint in the hand compared to LRTI.
Detailed description
This is a prospective, multicenter study with one treatment arm. Comparisons will be made to a performance target defined by subtracting a non-inferiority margin of 0.05 from an expected standard of care success rate of 0.55. The active treatment arm will receive a Cartiva® SCI for CMC.
A total of 74 subjects will be enrolled into the pivotal study.
Follow up visits will occur at the following time points after the surgical procedure: 2 week, 6 week, 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year.
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
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 22 years of age
- Refractory to conservative non-operative standard of care treatment for first CMC OA lasting for at least 6 months that requires surgical intervention
- Eaton classification stage II or III OA of the first CMC joint based on X-rays taken within 6 months of the Operative date and evidence of first CMC joint OA based on subjective review of associated clinical symptoms
- Preoperative VAS Pain score of ≥ 40 in the treated hand
- Preoperative 11 question QuickDASH score of ≥ 20
Key exclusion criteria (21 listed)
- Active systemic infection
- Active infection at the site of surgery
- Previous CMC implant, trapeziectomy, or LRTI to the affected joint to be treated
- Inflammatory arthropathy and/or diagnosis of grout
- History of or current diagnosis of rheumatoid arthritis
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 |
|---|---|---|
| CartivaSynthetic Cartilage Implant | Device | Cartiva |
Primary outcome
Pain measured by the Visual Analog Scale (VAS) scale
Time frame: 1 year
Success criteria: ≥ 30% VAS decrease at 12 months. Visual Analog Scale (VAS) Pain score will be obtained from the subject for pain in the treated hand by completing a CRF, which has a 100 mm horizontal line on it, with the left end indicating that the subject has no pain and the right end of the line indicating a lot of pain. The subject will be instructed to place a mark on the horizontal line to rate the average pain in the treated thumb joint over the past week. The designated site staff will use a metric ruler to measure the markings made by the subject on the VAS to determine the VAS score.
Function measured by QuickDASH
Time frame: 1 year
Success criteria: ≥ 15.9 point decrease at 12 months. QuickDASH functional score will be obtained from the subject. The QuickDASH, the shortened version of the DASH (Disabilities of the Arm, Shoulder, and Hand) Outcomes Measures, is a region-specific, self-reported questionnaire that uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. Subjects are asked to circle the appropriate response to each question based on their condition in the past week.
Radiographic Findings
Time frame: 1 year
Success criteria: Freedom from radiographic failures post-surgery through 12 months. Radiographic failures are defined as device dislocation, device fragmentation and/or development of avascular necrosis.
Key Subsequent Secondary Surgical Interventions (SSSIs)
Time frame: 1 year
Success criteria: Freedom from Subsequent Secondary Surgical Interventions (SSSIs) through 12 months. SSSIs are defined as revisions, removals, reoperations, and/or supplemental fixations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- 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.
Scott Wolfe, MD principal investigator
Hospital for Special Surgery, New York
Christopher Bainbridge, MB ChB, FRCSEd, CCST principal investigator
Royal Derby Hospital
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 9 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 3 Dec 2020. 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 States, 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.
Are results available for this study?
Results are not available in the source record.
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). The study lists 4 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 3 Dec 2020.