ROSA Total Knee Post Market Study EMEA

Sponsor
Zimmer Biomet
Study ID
NCT04338893
Status
Completed

Conditions

  • Avascular Necrosis of the Femoral Condyle
  • Chronic Osteoarthritis
  • Knee Pain
  • Moderate Varus, Valgus or Flexion Deformities
  • Rheumatoid Arthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Device: Persona Total Knee — PROCEDURE
    The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice
  • Device: NexGen Total Knee — PROCEDURE
    The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice
  • Device: Vanguard Total Knee — PROCEDURE
    The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice

Study Details

This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of surgical workflow efficiency, patient pain and function outcome and adverse events data. This study might include Persona, Nexgen and Vanguard product families using the ROSA Total Knee Robotic system or conventional instrumentation. The primary objective is to evaluate the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional instrumentation.

Key Dates

Start date
Dec 15, 2020
Status verified
Dec 2025
Primary completion
Aug 22, 2025
Completion
Aug 22, 2025

Study Design

Enrollment
252 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ROSA Total Knee Robotic Instrumentation
    Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
  • Active Comparator: Conventional TKA Instrumentation
    Total knee arthroplasty performed with conventional instrumentation

Primary Outcome Measure

Alignment Accuracy [ Time Frame: Pre-operative, 3 months ]

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