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

March 20, 2019 updated by: Cartiva, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • UBC, Division of Plastic Surgery
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Center
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Derby, United Kingdom, DE22 3NE
        • Royal Derby Hospital
      • Middlesborough, United Kingdom, TS 4 3BW
        • South Tees Hospital
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB15 6XS
        • Woodend Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cartiva
Synthetic Cartilage Implant
Device: Cartiva
Cartiva Synthetic Cartilage Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain measured by the Visual Analog Scale (VAS) scale
Time Frame: 1 year follow up
1 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cartiva, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2015

Primary Completion (Actual)

March 5, 2019

Study Completion (Actual)

March 5, 2019

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTC-0116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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