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

Osteoarthritis Clinical Trial

— GRIP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391506
• Other study ID #: PTC-0116
• Status: Completed
• Phase: N/A
• Start date: July 29, 2015
• Est. completion date: March 5, 2019

Study information

• Verified date: March 2019
• Source: Cartiva, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 5, 2019
• Est. primary completion date: March 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Cartiva
Cartiva Synthetic Cartilage Implant

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	QEII Health Sciences Center	Halifax	Nova Scotia
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	UBC, Division of Plastic Surgery	Vancouver	British Columbia
United Kingdom	Woodend Hospital	Aberdeen	Scotland
United Kingdom	Royal United Hospital	Bath
United Kingdom	Royal Derby Hospital	Derby
United Kingdom	South Tees Hospital	Middlesborough
United Kingdom	Queen Alexandra Hospital	Portsmouth

Sponsors (1)

Lead Sponsor	Collaborator
Cartiva, Inc.

Countries where clinical trial is conducted

Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measured by the Visual Analog Scale (VAS) scale		1 year follow up