Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-08-25
2026-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Experimental: Zimmer Biomet ROSA® Knee System, v1.5
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.
Total Knee Arthroplasty
Robotic-assisted primary total knee arthroplasty, evaluating updated features for the Zimmer Biomet ROSA® Knee System, v1.5.
Interventions
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Total Knee Arthroplasty
Robotic-assisted primary total knee arthroplasty, evaluating updated features for the Zimmer Biomet ROSA® Knee System, v1.5.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Locations
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Kensington Private Hospital
Kensington, Whangarei, New Zealand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CCA2025-20TDS
Identifier Type: -
Identifier Source: org_study_id
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