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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-29

Study Completion Date

2019-03-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Compared to LRTI (GRIP 2)

NCT03247439

Osteoarthritis

UNKNOWN NA

Post Approval Study to Evaluate the Effectiveness and Safety of Cartiva Implant in the Treatment of OA of the Great Toe

NCT02978573

Osteoarthritis of First Metatarsalphalangeal Joint

COMPLETED PHASE3

Metacarpophalangeal Joint Prostheses in Hand Surgery.

NCT06154421

Osteoarthritis Metacarpophalangeal Joint Rheumatoid Arthritis Metacarpophalangeal Joint

RECRUITING

Orthotic Management of CMC Osteoarthritis

NCT04297943

Arthritis Wrist

UNKNOWN NA

Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis

NCT05047744

Rhizarthrosis

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cartiva

Synthetic Cartilage Implant

Group Type EXPERIMENTAL

Cartiva

Intervention Type DEVICE

Cartiva Synthetic Cartilage Implant

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cartiva

Cartiva Synthetic Cartilage Implant

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No