ROSA® Knee System V1.5 Pilot Study

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.

Eligibility

Inclusion Criteria:

* Patient is a minimum of 18 years of age
* Independent of study participation, patient is a candidate for primary total knee arthroplasty using commercially available and compatible implants in accordance with product labeling
* Patient is willing and able to provide written Informed Consent by signing and dating the EC approved Informed Consent form

Exclusion Criteria:

* Patient is currently participating in any other surgical intervention studies or pain management studies
* Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
* Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

Conditions5

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