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ROSA Total Knee Post Market Study EMEA

CompletedNA

Sponsor: Zimmer Biomet

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

Interventions: Device: Persona Total Knee, Device: NexGen Total Knee, Device: Vanguard Total Knee

Countries: Belgium, Germany, Israel, Italy, Switzerland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion/Exclusion criteria Inclusion criteria:

* Patient is a minimum of 18 years of age
* Independent of study participation, patient is a candidate for commercially available Persona, NexGen, or Vanguard knee components implanted in accordance with product labeling
* Patient has participated in this study-related Informed Consent Process
* Patient is willing and able to provide written Informed Consent by signing and dating the EC approved Informed Consent form
* Patient is willing and able to complete scheduled study procedures and follow-up evaluations

Exclusion criteria:

* Patient is currently participating in any other surgical intervention studies or pain management studies
* Patient has underwent contralateral UKA or TKA within the last 18 months
* Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
* Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation)
* 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

Locations (6)

Brussels, Belgium
Braunschweig, Germany
Spandau, Germany
Jerusalem, Israel
Arezzo, Italy
Geneva, Switzerland