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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT07009912
Brief Summary:
This pilot study seeks to evaluate the initial safety and usability of new features for the ROSA® Knee System, v1.5 and plan design modifications as needed.
The primary objectives will be assessed by measuring:
1. Intra-operative complications
2. Verification that the device performs as intended
3. Overall surgeon satisfaction with the instrumentation.
Detailed Description:
This study will involve single-arm, monocentric, cross-sectional observations conducted on the day of surgery. All assessments will take place during the pre-operative, intra-operative, and immediate postop periods on the day of surgery, with no additional follow-up beyond the procedure as robotic-assisted surgery using the current version of the robot is part of routine practice.
The safety of the system is the primary endpoint. This will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary endpoint is defined by the usability of Zimmer Biomet ROSA® Knee System, v1.5. It will be assessed by:
1. Robotic log files to assess differences in the proposed plans by the system's new features and plan approved by the surgeon, along with time spent in the planning panel.
2. Surgeon satisfaction with the new features.
Study:
NCT07009912
Study Brief:
Protocol Section:
NCT07009912