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First received: May 21, 2025

Clinical Trial: ROSA® Knee System V1.5 Pilot Study

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Knee Arthroplasty, Total

Study Type: INTERVENTIONAL


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

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:Intra-operative complicationsVerification that the device performs as intendedOverall surgeon satisfaction with the instrumentation.

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