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Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Compared to LRTI (GRIP 2) (GRIP 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03247439
Recruitment Status : Active, not recruiting
First Posted : August 11, 2017
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Cartiva, Inc.

Tracking Information
First Submitted Date  ICMJE August 4, 2017
First Posted Date  ICMJE August 11, 2017
Last Update Posted Date March 22, 2019
Actual Study Start Date  ICMJE December 22, 2017
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
  • Pain measured by the Visual Analog Scale (VAS) scale [ Time Frame: 1 year ]
    Visual Analog Scale (VAS) Pain
  • Function measured by QuickDASH [ Time Frame: 1 year ]
    QuickDASH functional score
  • Radiographic Findings [ Time Frame: 1 year ]
    Freedom from radiographic failures post-surgery
  • Safety [ Time Frame: 1 year ]
    Freedom from Subsequent Secondary Surgical Interventions
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03247439 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Compared to LRTI (GRIP 2)
Official Title  ICMJE 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
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Device: Cartiva
Synthetic Cartilage Implant
Study Arms  ICMJE Experimental: Cartiva
Synthetic Cartilage Implant
Intervention: Device: Cartiva
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 9, 2017)
74
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥ 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
  • Be willing and able to return for all study-related follow up procedures

Exclusion Criteria:

  • Previous CMC implant, trapeziectomy, or LRTI to the affected joint to be treated
  • History of or current diagnosis of rheumatoid arthritis
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03247439
Other Study ID Numbers  ICMJE PTC-0290
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cartiva, Inc.
Study Sponsor  ICMJE Cartiva, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott Wolfe, MD Hospital for Special Surgery, New York
PRS Account Cartiva, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP