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Implant

Cartiva Implant for Hand Osteoarthritis (GRIP 2 Trial)

N/A
Waitlist Available
Led By Scott Wolfe, MD
Research Sponsored by Cartiva, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
≥ 22 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

GRIP 2 Trial Summary

This trial will compare the effectiveness of Cartiva to LRTI for treating osteoarthritis of the first CMC joint in the hand.

Who is the study for?
Adults over 22 with moderate osteoarthritis in the thumb joint, who haven't improved with standard non-surgical treatments for at least 6 months. Participants must have a certain level of pain and disability, good bone quality without significant loss or cysts, and be able to complete questionnaires. Excluded are those with infections, previous similar surgeries, inflammatory diseases like rheumatoid arthritis, recent cancer treatment affecting the arm, systemic diseases that could affect results or healing, current pregnancy or inadequate contraception use.Check my eligibility
What is being tested?
The trial is testing if Cartiva—an implant—works better than a common surgical procedure called LRTI for treating thumb joint osteoarthritis. Patients will receive either Cartiva or undergo LRTI surgery and their outcomes will be compared to determine which is more effective in reducing pain and improving hand function.See study design
What are the potential side effects?
Potential side effects may include infection at the surgery site, allergic reactions to materials in the implant (polyvinyl alcohol), complications from surgery such as poor wound healing especially in individuals with uncontrolled diabetes mellitus or other conditions known to impact healing.

GRIP 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My thumb joint arthritis is at stage II or III, confirmed by recent X-rays.
Select...
I am 22 years old or older.
Select...
My hand arthritis hasn't improved with standard treatments for 6 months and needs surgery.
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My bones are strong and do not require a bone graft.
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My hand pain level is 40 or more on a scale of 0-100.

GRIP 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Function measured by QuickDASH
Key Subsequent Secondary Surgical Interventions (SSSIs)
Pain measured by the Visual Analog Scale (VAS) scale
+1 more

GRIP 2 Trial Design

1Treatment groups
Experimental Treatment
Group I: CartivaExperimental Treatment1 Intervention
Synthetic Cartilage Implant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cartiva
2009
Completed Phase 3
~430

Find a Location

Who is running the clinical trial?

Cartiva, Inc.Lead Sponsor
6 Previous Clinical Trials
493 Total Patients Enrolled
4 Trials studying Osteoarthritis
438 Patients Enrolled for Osteoarthritis
Scott Wolfe, MDPrincipal InvestigatorHospital for Special Surgery, New York
Christopher Bainbridge, MB ChB, FRCSEd, CCSTPrincipal InvestigatorRoyal Derby Hospital

Media Library

Cartiva Implant (Implant) Clinical Trial Eligibility Overview. Trial Name: NCT03247439 — N/A
Osteoarthritis Research Study Groups: Cartiva
Osteoarthritis Clinical Trial 2023: Cartiva Implant Highlights & Side Effects. Trial Name: NCT03247439 — N/A
Cartiva Implant (Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03247439 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues are currently offering this research endeavor?

"Presently, the trial is being hosted at 5 separate sites. These are situated in San Diego, Indianapolis and New york City with 2 additional spots scattered elsewhere. It's recommended that participants select a location near them to diminish travel burdens if they choose to join the study."

Answered by AI

Is this medical research in need of additional participants?

"Unfortunately, the data hosted on clinicaltrials.gov indicates that this medical study is not currently recruiting patients - it was initially posted in December 2017 and updated last in December 2020. However, 613 other studies are actively searching for participants at present time."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
New York
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
What site did they apply to?
Hospital for Specialty Surgery

Why did patients apply to this trial?

I have had steroid injections with limited relief. Hand PT with some relief.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Compared to LRTI (GRIP 2)
2017. "Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Compared to LRTI (GRIP 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03247439.
All > Oa
~10 spots leftby Apr 2025
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