ROSA® Knee System V1.5 Pilot Study

NCT07009912 | Completed

• 1 other identifier: CCA2025-20TDS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Intra-operative complications
2. 2.Verification that the device performs as intended
3. 3.Overall surgeon satisfaction with the instrumentation.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Procedure-Emergent Adverse Events, to assess the Safety of the ROSA® Knee System v1.5 System

  The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. This will occur through the reporting of adverse events that outline the details and relationship to: 1. Device 2. Procedure 3. Instruments 4. Cement in order to determine device-related or non-device-related complications that occur during the procedure. Thus the incidence of procedure-emergent adverse events will notify and quantify the safety of the features added to the subject device (ROSA® Knee System v1.5 System)

  Intra-operative observations, with immediate post-operative documentation and reporting period.

Secondary Outcomes (1)

• Verification and Usability of the OptimiZe Planning and Activ Track Investigational Features of the ROSA® Knee System v1.5 System

  Intra-operative evaluation, with immediate post-operative assessment and documentation. Data and statistical analysis will take place after the recruitment period has concluded.

Study Arms (1)

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

EXPERIMENTAL

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.

Device: Total Knee Arthroplasty

Interventions

Total Knee Arthroplasty DEVICE

Robotic-assisted primary total knee arthroplasty, evaluating updated features for the Zimmer Biomet ROSA® Knee System, v1.5.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Kensington Private Hospital

Kensington, Whangarei, 0112, New Zealand

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Osteoarthritis; Arthritis; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, monocentric, cross-sectional, pilot study

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 8, 2025
• Study Start: February 25, 2025
• Primary Completion: February 17, 2026
• Study Completion: February 17, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)