Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-02-03 @ 10:53 PM
Study NCT ID:
NCT07009912
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-08
First Post:
2025-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ROSA® Knee System V1.5 Pilot Study
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
A Single-arm, Monocentric, Cross-sectional, Pilot Study Evaluating Updated Features for The ROSA® Knee System, v1.5, in Patients Undergoing Primary Total Knee Arthroplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: