Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT00578994
Brief Summary:
The purpose of this study is to collect information on complications and survivorship of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.
Detailed Description:
Study Objective
To provide a prospective 2-year post-operative evaluation of complications and 9-year long-term survivorship analysis of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.
Study Design
The study is designed as a prospective, multi-center, non-randomized post approval study. There are two phases to this study:
1. A complications study where patients will be followed for at least 2 years to record all complications that may occur, and
2. A survival study that will record at yearly intervals out to 9 years whether or not the device is still in place or if it has been removed for any reason.
Phase 1 requires clinical follow-up (0-2 year) and patients will be evaluated at pre-defined intervals up to 2 years post-operative. Information gathered in phase 1 includes all adverse events and survival data.
Phase 2 (3-9 year) only gathers survival data through patient directed mailing and/or phone call.
Study:
NCT00578994
Study Brief:
Protocol Section:
NCT00578994