ROSA Total Knee Post Market Study EMEA

Rheumatoid Arthritis Clinical Trial

Official title:

ROSA Total Knee Post Market Study: a Prospective, Multicenter EMEA Post Market Clinical Follow up of the ROSA Knee System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04338893
• Other study ID #: CME2019-24K
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Germany	Herzogin Elisabeth Hospital	Braunschweig
Germany	Evangelisches Waldkrankenhaus Spandau	Spandau
Israel	The Research Fund of Hadassah Medical Organization	Jerusalem
Italy	San Giuseppe Hospital	Arezzo
Switzerland	Hôpitaux Universitaires de Genève	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Belgium,  Germany,  Israel,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the accuracy of implant alignment for ROSA total knee robotic instrumentation compared to conventional instrumentation	measuring femoral rotation in the axial plane using pre and post op CT assessments	1 year
Secondary	Measure operative workflow efficiency by recording following time points during surgery	time points recorded are: patient in-and out time, incision- and incision closed time	1 year
Secondary	Evaluate the change of the Oxford Knee Score between baseline and each post-operative follow up	Oxford Knee Score is a patient-reported form and consists of 12 questions on the influence of the knee (surgical side) on daily activities or pain. The patient scores each question (item) from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome).	1 year
Secondary	Evaluate Health related quality of life at baseline and each post-operative follow up	EQ-5D-5L health questionnaireEuroqol-5 dimensions by the EuroQol Group consists of a descriptive system of health-related quality of life by a questionnaire and a thermometer scale. The Questionnaire comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with each 5 levels: no problems (level 1), slight problems (level 2), moderate problems, (level 3) severe problems (level 4) and extreme problems (level 5). The digits for the five dimensions can be combined into a 5-digit number and may be converted to a score (maximum is 1), defined by the health state classification.The Thermometer generates a self rating of current health-related quality of life and has end points of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. It should be used with the 5-digit health state classification to build a composite picture of the respondent's health status.	1 year
Secondary	Evaluate Pain intensity at baseline and each post-operative follow up	NRS Pain (Numeric Rating Scale for Pain). NRS Pain is a numeric scale from 0 to 10 to measure pain intensity from 0 (no pain) to 10 (worst imaginable pain)	1 year
Secondary	Evaluate knee functionality at baseline and each post-operative follow up	Objective Knee Assessment is used to assess knee functionality by the investigator with objective knee indicators (2011 The Knee Society) up to 100 points. A higher score means a better functional outcome	1 year
Secondary	Evaluate awareness of patients affected knee joint at baseline and each post operative follow up	FJS-12 is a patient-reported form and consist of 12 questions to assess awareness of patients affected knee joint in daily activities.all responses are summed (never, 0 points; almost never, 1 point; seldom, 2 points; sometimes, 3 points; mostly, 4 points) and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 top 100. A high score indicate a high degree of "forgetting" the artificial joint, i.e. a lower degree of awareness.	1 year
Secondary	Evaluate patient satisfaction at baseline (first postop visit) and each post operative follow up	Patients to provide additional information regarding the level of satisfaction with the operated knee by answering 4 questions with 4 options to answer from very satisfied, satisfied, dissatisfied to very dissatisfied	1 year