Avascular Necrosis of the Femoral Condyle, Chronic Osteoarthritis, Knee Pain, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
Conditions
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
Interventions
PROCEDUREDevice: Persona Total Knee
The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice
PROCEDUREDevice: NexGen Total Knee
The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice
PROCEDUREDevice: Vanguard Total Knee
The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice
Sponsors
Zimmer Biomet
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alignment Accuracy | Pre-operative, 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Workflow Efficiency | Intraoperative | Measure operative workflow efficiency by recording following time points during surgery: Patient in -and out time, incision - and incision closed time |
| Oxford Knee Score (OKS) | Pre-operative, 6 weeks, 3 months, 1 year | 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 |
| EuroQol 5D (EQ-5D) - Score | Pre-operative, 6 weeks, 3 months, 1 year | The EQ-5D is a standardized instrument widely used to measure health status, and it is a self-reported assessment about the patient's quality of life. The questionnaire includes 5 questions referring to mobility, self-care, daily/usual activities, pain/discomfort and anxiety/depression. For EQ-5D-5L, each question can be answered in five ways, indicating no, slight, moderate, severe or extreme pain. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573; negative numbers correspond to a self-assessed health state worse than being dead. |
| EuroQol 5D (EQ-5D) VAS Scale | Pre-operative, 6 weeks, 3 months, 1 year | The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her self-rated health. |
| NRS (Numeric Rating Scale) Pain | Pre-operative, 6 weeks, 3 months, 1 year | The NRS Pain is an outcome measure of pain intensity in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Scores range from 0-10 points, with 0 representing "no pain" to 10 representing "worst imaginable pain". |
| Forgotten Joint Score (FJS) | Pre-operative, 6 weeks, 3 months, 1 year | The FJS-12 is a patient-reported outcome questionnaire that was developed to specifically assess the patient's level of awareness of having a joint prosthesis during daily activities. The FJS consists of twelve questions covering function and pain associated with the knee. For each question, there is a choice of five answers between never (0), almost never (1), seldom (2), sometimes (3) and mostly (4). All scores are summed up and divided by the number of completed items. This value is then multiplied by 25 and thereafter subtracted from 100. An outcome score of 100 (highest possible score) indicates the lowest level of awareness of having a joint prosthesis, while a total score of 0 indicates the highest level of awareness of having a joint prosthesis. |
| Patient Satisfaction - Question 1 | 6 weeks, 3 months, 1 year | Patients were asked to answer the following question: "How satisfied are you with the results of your surgery?" by selecting from the answers: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied. |
| Patient Satisfaction - Question 2 | 6 weeks, 3 months, 1 year | Patients were asked to answer the following question: "How satisfied are you with the results of your surgery for improving your pain?" by selecting from the answers: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied. |
| Patient Satisfaction - Question 3 | 6 weeks, 3 months, 1 year | Patients were asked to answer the following question: "How satisfied are you with the results of your surgery for improving your ability to do home or yard work?" by selecting from the answers: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied. |
| Patient Satisfaction - Question 4 | 6 weeks, 3 months, 1 year | Patients were asked to answer the following question: "How satisfied are you with the results of your surgery for improving your ability to do recreational activities?" by selecting from the answers: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied. |
Countries
Belgium, Germany, Israel, Italy, Switzerland
Contacts
STUDY_DIRECTOREmilie Rohmer
Zimmer Biomet
Participant flow
Pre-assignment details
31 patients not assigned to any group: 27 screen failures, 1 cancelled operation, 3 recorded as lost to follow-up for other reasons
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70.5 years STANDARD_DEVIATION 8.3 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 1 / 101 |
| other Total, other adverse events | 21 / 120 | 21 / 101 |
| serious Total, serious adverse events | 19 / 120 | 13 / 101 |
Outcome results
None listed