Back to resultsROSA Total Knee Post Market Study EMEA
Primary Purpose
Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Device: Persona Total Knee
Device: NexGen Total Knee
Device: Vanguard Total Knee
Sponsored by
About this trial
This is an interventional treatment trial for Knee Pain
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
Sites / Locations
- Cliniques Universitaires Saint-LucRecruiting
- Herzogin Elisabeth Hospital
- Evangelisches Waldkrankenhaus Spandau
- The Research Fund of Hadassah Medical Organization
- San Giuseppe Hospital
- Hôpitaux Universitaires de Genève
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ROSA Total Knee Robotic Instrumentation
Conventional TKA Instrumentation
Arm Description
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
Total knee arthroplasty performed with conventional instrumentation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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).
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.
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)
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
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04338893
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ROSA Total Knee Robotic Instrumentation
Arm Type
Active Comparator
Arm Description
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
Arm Title
Conventional TKA Instrumentation
Arm Type
Active Comparator
Arm Description
Total knee arthroplasty performed with conventional instrumentation
Intervention Type
Procedure
Intervention Name(s)
Device: Persona Total Knee
Intervention Description
The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice
Intervention Type
Procedure
Intervention Name(s)
Device: NexGen Total Knee
Intervention Description
The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice
Intervention Type
Procedure
Intervention Name(s)
Device: Vanguard Total Knee
Intervention Description
The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice
Primary Outcome Measure Information:
Title
Evaluate the accuracy of implant alignment for ROSA total knee robotic instrumentation compared to conventional instrumentation
Description
measuring femoral rotation in the axial plane using pre and post op CT assessments
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Measure operative workflow efficiency by recording following time points during surgery
Description
time points recorded are: patient in-and out time, incision- and incision closed time
Time Frame
1 year
Title
Evaluate the change of the Oxford Knee Score between baseline and each post-operative follow up
Description
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).
Time Frame
1 year
Title
Evaluate Health related quality of life at baseline and each post-operative follow up
Description
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.
Time Frame
1 year
Title
Evaluate Pain intensity at baseline and each post-operative follow up
Description
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)
Time Frame
1 year
Title
Evaluate knee functionality at baseline and each post-operative follow up
Description
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
Time Frame
1 year
Title
Evaluate awareness of patients affected knee joint at baseline and each post operative follow up
Description
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.
Time Frame
1 year
Title
Evaluate patient satisfaction at baseline (first postop visit) and each post operative follow up
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chiara Griffoni
Phone
+41795601628
Email
chiara.griffoni@zimmerbiomet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Achakri
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Thienpont, Prof.
Facility Name
Herzogin Elisabeth Hospital
City
Braunschweig
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Evangelisches Waldkrankenhaus Spandau
City
Spandau
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
The Research Fund of Hadassah Medical Organization
City
Jerusalem
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
San Giuseppe Hospital
City
Arezzo
Country
Italy
Individual Site Status
Completed
Facility Name
Hôpitaux Universitaires de Genève
City
Geneva
Country
Switzerland
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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ROSA Total Knee Post Market Study EMEA
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