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
Verified date | April 2024 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
Belgium, Germany, Israel, Italy, Switzerland,
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 |
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