Clinical trial NCT04338893: ROSA Total Knee Post Market Study EMEA
Official title: ROSA Total Knee Post Market Study: a Prospective, Multicenter EMEA Post Market Clinical Follow up of the ROSA Knee System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Pain
Chronic Osteoarthritis
Avascular Necrosis of the Femoral Condyle
Moderate Varus, Valgus or Flexion Deformities
Rheumatoid Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2020-04-08
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

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

Primary outcomes:
measure: Evaluate the accuracy of implant alignment for ROSA total knee robotic instrumentation compared to conventional instrumentation
timeFrame: 1 year
Secondary outcomes:
measure: Measure operative workflow efficiency by recording following time points during surgery
timeFrame: 1 year
measure: Evaluate the change of the Oxford Knee Score between baseline and each post-operative follow up
timeFrame: 1 year
measure: Evaluate Health related quality of life at baseline and each post-operative follow up
timeFrame: 1 year
measure: Evaluate Pain intensity at baseline and each post-operative follow up
timeFrame: 1 year
measure: Evaluate knee functionality at baseline and each post-operative follow up
timeFrame: 1 year
measure: Evaluate awareness of patients affected knee joint at baseline and each post operative follow up
timeFrame: 1 year
measure: Evaluate patient satisfaction at baseline (first postop visit) and each post operative follow up
timeFrame: 1 year
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Braunschweig
country: Germany
facility: Herzogin Elisabeth Hospital
city: Spandau
country: Germany
facility: Evangelisches Waldkrankenhaus Spandau
city: Jerusalem
country: Israel
facility: The Research Fund of Hadassah Medical Organization
city: Arezzo
country: Italy
facility: San Giuseppe Hospital
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: