ROSA® Knee System V1.5 Pilot Study

Zimmer Biomet

Status: Enrolling

Conditions: Joint Diseases; Knee Arthroplasty, Total; Robotic Surgical Procedures; Knee Osteoarthritis

Treatments: Device: Total Knee Arthroplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT07009912

CCA2025-20TDS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Experimental: Zimmer Biomet ROSA® Knee System, v1.5

Experimental group

Description:

This study will include a single-arm of patients who qualify for robotic-assisted (RA) total knee arthroplasty (TKA) with the ROSA® Knee System and are planned to receive commercially available and compatible implants.

Treatment:

Device: Total Knee Arthroplasty