ROSA Total Knee Post Market Study EMEA

Zimmer Biomet252 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

252

Conditions

Knee Pain

Interventions

Device: Persona Total KneePROCEDURE

The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice

Device: NexGen Total KneePROCEDURE

The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice

Device: Vanguard Total KneePROCEDURE

The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Herzogin Elisabeth Hospital

Braunschweig, Germany

Evangelisches Waldkrankenhaus Spandau

Spandau, Germany

The Research Fund of Hadassah Medical Organization

Jerusalem, Israel

San Giuseppe Hospital

Arezzo, Italy

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Outcomes

Primary Outcomes

Alignment Accuracy

Evaluate the accuracy of implant component alignment for ROSA Total Knee robotic instrumentation compared to conventional instrumentation, by measuring femoral rotation in the axial plane using pre op and post op CT assessments.

Time frame: Pre-operative, 3 months

Secondary Outcomes

Operative Workflow Efficiency

Measure operative workflow efficiency by recording following time points during surgery: Patient in -and out time, incision - and incision closed time

Time frame: Intraoperative

Oxford Knee Score (OKS)

The OKS is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following TKA. The OKS consists of twelve questions covering function and pain associated with the knee. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27