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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROSA Total Knee Robotic Instrumentation | Active Comparator | Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation |
|
| Conventional TKA Instrumentation | Active Comparator | Total knee arthroplasty performed with conventional instrumentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: Persona Total Knee | Procedure | The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alignment Accuracy | 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. | Pre-operative, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Workflow Efficiency | Measure operative workflow efficiency by recording following time points during surgery: Patient in -and out time, incision - and incision closed time | Intraoperative |
| Oxford Knee Score (OKS) |
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Inclusion/Exclusion criteria Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilie Rohmer | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | ||||
| Herzogin Elisabeth Hospital |
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31 patients not assigned to any group: 27 screen failures, 1 cancelled operation, 3 recorded as lost to follow-up for other reasons
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| ID | Title | Description |
|---|---|---|
| FG000 | Robotic | Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation |
| FG001 | Conventional | Total knee arthroplasty performed with conventional instrumentation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Robotic | Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation |
| BG001 | Conventional | Total knee arthroplasty performed with conventional instrumentation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alignment Accuracy | 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. | CT scans were taken from participants enrolled in this patients sub-cohort; however, following longer study duration and fewer enrolled patients than originally planned, the scans analysis was not performed, as the reduced sample size limited interpretability, resources were reallocated, and the research question was no longer considered novel. The study documents did not specify what to do in the case of incomplete enrollment and there are no plans to process the images in the future. | Posted | Pre-operative, 3 months |
|
From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robotic | Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection (knee) | Surgical and medical procedures | Systematic Assessment | Required revision surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Restricted Mobility Patella / Abnormal Patellar Tracking | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chiara Griffoni, Clinical Project Senior Lead | Zimmer Biomet | +41 79 560 16 28 | chiara.griffoni@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2020 | Dec 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056304 | Genu Valgum |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| Device: NexGen Total Knee | Procedure | The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice |
|
| Device: Vanguard Total Knee | Procedure | The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice |
|
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
| Pre-operative, 6 weeks, 3 months, 1 year |
| EuroQol 5D (EQ-5D) - Score | 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, 6 weeks, 3 months, 1 year |
| EuroQol 5D (EQ-5D) VAS Scale | 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. | Pre-operative, 6 weeks, 3 months, 1 year |
| NRS (Numeric Rating Scale) Pain | 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". | Pre-operative, 6 weeks, 3 months, 1 year |
| Forgotten Joint Score (FJS) | 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. | Pre-operative, 6 weeks, 3 months, 1 year |
| Patient Satisfaction - Question 1 | 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. | 6 weeks, 3 months, 1 year |
| Patient Satisfaction - Question 2 | 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. | 6 weeks, 3 months, 1 year |
| Patient Satisfaction - Question 3 | 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. | 6 weeks, 3 months, 1 year |
| Patient Satisfaction - Question 4 | 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, 3 months, 1 year |
| Braunschweig |
| Germany |
| Evangelisches Waldkrankenhaus Spandau | Spandau | Germany |
| The Research Fund of Hadassah Medical Organization | Jerusalem | Israel |
| San Giuseppe Hospital | Arezzo | Italy |
| Hôpitaux Universitaires de Genève | Geneva | Switzerland |
| Adverse Event |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Conventional | Total knee arthroplasty performed with conventional instrumentation |
|
| Secondary | Operative Workflow Efficiency | Measure operative workflow efficiency by recording following time points during surgery: Patient in -and out time, incision - and incision closed time | Information not collected for 2 conventional patients | Posted | Mean | Standard Deviation | minutes | Intraoperative |
|
|
|
| Secondary | Oxford Knee Score (OKS) | 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 | Some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 6 weeks, 3 months, 1 year |
|
|
|
| Secondary | EuroQol 5D (EQ-5D) - Score | 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. | Some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 6 weeks, 3 months, 1 year |
|
|
|
| Secondary | EuroQol 5D (EQ-5D) VAS Scale | 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. | Some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 6 weeks, 3 months, 1 year |
|
|
|
| Secondary | NRS (Numeric Rating Scale) Pain | 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". | Some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 6 weeks, 3 months, 1 year |
|
|
|
| Secondary | Forgotten Joint Score (FJS) | 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. | Some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 6 weeks, 3 months, 1 year |
|
|
|
| Secondary | Patient Satisfaction - Question 1 | 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. | Some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Count of Participants | Participants | 6 weeks, 3 months, 1 year |
|
|
|
| Secondary | Patient Satisfaction - Question 2 | 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. | Some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Count of Participants | Participants | 6 weeks, 3 months, 1 year |
|
|
|
| Secondary | Patient Satisfaction - Question 3 | 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. | Some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Count of Participants | Participants | 6 weeks, 3 months, 1 year |
|
|
|
| Secondary | Patient Satisfaction - Question 4 | 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. | Some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Count of Participants | Participants | 6 weeks, 3 months, 1 year |
|
|
|
| 0 |
| 120 |
| 19 |
| 120 |
| 21 |
| 120 |
| EG001 | Conventional | Total knee arthroplasty performed with conventional instrumentation | 1 | 101 | 13 | 101 | 21 | 101 |
|
| Post-operative cement leftover | Surgical and medical procedures | Systematic Assessment | Required revision surgery |
|
| Robotic malfunction | Product Issues | Systematic Assessment |
|
| Effusion/Swelling/Edema | Blood and lymphatic system disorders | Systematic Assessment |
|
| Vastus Lateralis Querruptur | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Stiffness/Limited ROM | Musculoskeletal and connective tissue disorders | Systematic Assessment | Required manipulation under anesthesia |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Wound complication | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
|
| Coronary heart disease | Cardiac disorders | Systematic Assessment |
|
| Cardiac catheterization | Surgical and medical procedures | Systematic Assessment |
|
| Shoulder replacement | Surgical and medical procedures | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Kidney Failure | Renal and urinary disorders | Systematic Assessment |
|
| Cholecystitis | Surgical and medical procedures | Systematic Assessment |
|
| Contralateral Knee Replacement | Surgical and medical procedures | Systematic Assessment |
|
| Ureteral stenosis | Surgical and medical procedures | Systematic Assessment |
|
| Nephrostomy | Surgical and medical procedures | Systematic Assessment |
|
| Post-operative encephalopathy | Nervous system disorders | Systematic Assessment |
|
| Gastric bypass | Surgical and medical procedures | Systematic Assessment |
|
| Discectomy | Surgical and medical procedures | Systematic Assessment |
|
| Stiffness/Limited ROM | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Effusion/Swelling/Edema | Vascular disorders | Systematic Assessment |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dental-related problems | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Covid infection | Infections and infestations | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Heart surgery | Surgical and medical procedures | Systematic Assessment |
|
| Eye surgery | Surgical and medical procedures | Systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| 6 weeks |
|
|
| 3 months |
|
|
| 1 year |
|
|
| 6 weeks |
|
|
| 3 months |
|
|
| 1 year |
|
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| 6 weeks |
|
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| 3 months |
|
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| 1 year |
|
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| 6 weeks |
|
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| 3 months |
|
|
| 1 year |
|
|
| 6 weeks |
|
|
| 3 months |
|
|
| 1 year |
|
|
| Somewhat satisfied |
|
| Somewhat dissatisfied |
|
| Very dissatisfied |
|
| 3 months |
|
|
| 1 year |
|
|
| Somewhat satisfied |
|
| Somewhat dissatisfied |
|
| Very dissatisfied |
|
| 3 months |
|
|
| 1 year |
|
|
| Somewhat satisfied |
|
| Somewhat dissatisfied |
|
| Very dissatisfied |
|
| 3 months |
|
|
| 1 year |
|
|
| Somewhat satisfied |
|
| Somewhat dissatisfied |
|
| Very dissatisfied |
|
| 3 months |
|
|
| 1 year |
|
|