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
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.
Pre-operative
Group
Value
95% CI
Robotic
0.371
± 0.336
Conventional
0.388
± 0.303
6 weeks
Group
Value
95% CI
Robotic
0.717
± 0.204
Conventional
0.691
± 0.232
3 months
Group
Value
95% CI
Robotic
0.816
± 0.160
Conventional
0.762
± 0.266
1 year
Group
Value
95% CI
Robotic
0.865
± 0.179
Conventional
0.817
± 0.238
EuroQol 5D (EQ-5D) VAS ScaleSecondary· 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.
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".
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) in
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.
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.
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.
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.
6 weeks
Group
Value
95% CI
Robotic
34
Conventional
17
Robotic
54
Conventional
52
Robotic
14
Conventional
16
Robotic
4
Conventional
4
3 months
Group
Value
95% CI
Robotic
55
Conventional
37
Robotic
37
Conventional
36
Robotic
10
Conventional
10
Robotic
2
Conventional
5
1 year
Group
Value
95% CI
Robotic
45
Conventional
43
Robotic
33
Conventional
22
Robotic
3
Conventional
9
Robotic
1
Conventional
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From study start up to 1 year post-operatively.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zimmer Biomet
Last refreshed: 21 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04338893.