ROSA Total Knee Post Market Study EMEA

Zimmer Biomet

Status: Completed

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

Treatments: Procedure: Device: NexGen Total Knee; Procedure: Device: Vanguard Total Knee; Procedure: Device: Persona Total Knee

Study type: Interventional

Funder types: Industry

Identifiers

NCT04338893

CME2019-24K

Details and patient eligibility

About

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.

Full description

The main purpose of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation. This will be achieved by assessing: planned vs actual component positioning, operative workflow efficiency, patient safety based on incidence and frequency of adverse events, clinical performance measured by overall pain and function, health-related quality of life data and radiographic parameters.

The primary endpoint will report on the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional and the secondary endpoints will record surgery time points and evaluate the change of clinical outcomes scores between baseline and post operative follow up for performance and clinical benefits

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 2 patient groups

ROSA Total Knee Robotic Instrumentation

Active Comparator group

Description:

Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation

Treatment:

Procedure: Device: Persona Total Knee

Procedure: Device: Vanguard Total Knee

Procedure: Device: NexGen Total Knee

Conventional TKA Instrumentation

Active Comparator group

Description:

Total knee arthroplasty performed with conventional instrumentation

Treatment:

Procedure: Device: Persona Total Knee

Procedure: Device: Vanguard Total Knee

Procedure: Device: NexGen Total Knee