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

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: NCT02391506
Recruitment Status : Active, not recruiting
First Posted : March 18, 2015
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Cartiva, Inc.

March 9, 2015
March 18, 2015
March 27, 2018
May 2015
December 2018   (Final data collection date for primary outcome measure)
Pain measured by the Visual Analog Scale (VAS) scale [ Time Frame: 1 year follow up ]
  • Pain measured by the Visual Analog Scale (VAS) scale [ Time Frame: 1 year follow up ]
  • Hand Function as measured by the Quick Disabilities of Arm Shoulder and Hand questionaire (QuickDash) [ Time Frame: 1 year follow up ]
  • Safety measured by the absence of key safety issues [ Time Frame: 1 year follow up ]
Complete list of historical versions of study NCT02391506 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis
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.

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, and 1 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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteoarthritis
Device: Cartiva
Cartiva Synthetic Cartilage Implant
Experimental: Cartiva
Synthetic Cartilage Implant
Intervention: Device: Cartiva
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ≥ 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

Exclusion Criteria:

  • < 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United Kingdom
 
 
NCT02391506
PTC-0116
Yes
Not Provided
Plan to Share IPD: No
Cartiva, Inc.
Cartiva, Inc.
Not Provided
Not Provided
Cartiva, Inc.
March 2018

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