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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 : Completed
First Posted : March 18, 2015
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Cartiva, Inc.

Brief Summary:
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the CMC joint in the hand.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Cartiva Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 29, 2015
Actual Primary Completion Date : March 5, 2019
Actual Study Completion Date : March 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Cartiva
Synthetic Cartilage Implant
Device: Cartiva
Cartiva Synthetic Cartilage Implant




Primary Outcome Measures :
  1. Pain measured by the Visual Analog Scale (VAS) scale [ Time Frame: 1 year follow up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391506


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

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Responsible Party: Cartiva, Inc.
ClinicalTrials.gov Identifier: NCT02391506     History of Changes
Other Study ID Numbers: PTC-0116
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cartiva, Inc.:
First CMC joint
Osteoarthritis
Cartilage Replacement
First CMC Joint Osteoarthritis
Damaged Articular Surface
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases