Clinical trial NCT02391506: Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: First CMC joint
Osteoarthritis
Cartilage Replacement
First CMC Joint Osteoarthritis
Damaged Articular Surface
Lead sponsor: Cartiva, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Pain measured by the Visual Analog Scale (VAS) scale
timeFrame: 1 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: UBC, Division of Plastic Surgery
state: British Columbia
city: Halifax
country: Canada
facility: QEII Health Sciences Center
state: Nova Scotia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Aberdeen
country: United Kingdom
facility: Woodend Hospital
state: Scotland
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Middlesborough
country: United Kingdom
facility: South Tees Hospital
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
Study officials:
References: