N/A
Completed N=221
ROSA Total Knee Post Market Study EMEA
Postoperative Pain · Chronic Osteoarthritis · Avascular Necrosis of the Femoral Condyle · Moderate Varus, Valgus or Flexion Deformities
Source: ClinicalTrials.gov NCT04338893 ↗
Enrolled (actual)
221
Serious AEs
14.5%
Results posted
Jan 2026
Primary outcomePrimary: Alignment Accuracy
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alignment Accuracy |
— | — |
| SECONDARY Operative Workflow Efficiency |
161.6; 138.8; 91.5; 77.5 | — |
| SECONDARY Oxford Knee Score (OKS) |
21.5; 20.6; 30.5; 29.0; 36.3; 35.0 | — |
| SECONDARY EuroQol 5D (EQ-5D) - Score |
0.371; 0.388; 0.717; 0.691; 0.816; 0.762 | — |
| SECONDARY EuroQol 5D (EQ-5D) VAS Scale |
64.8; 64.6; 73.8; 73.9; 78.6; 78.1 | — |
| SECONDARY NRS (Numeric Rating Scale) Pain |
7.2; 7.5; 3.4; 3.2; 2.3; 2.3 | — |
| SECONDARY Forgotten Joint Score (FJS) |
21.3; 17.6; 42.4; 37.1; 60.5; 55.3 | — |
| SECONDARY Patient Satisfaction - Question 1 |
54; 49; 42; 29; 8; 10 | — |
| SECONDARY Patient Satisfaction - Question 2 |
41; 31; 51; 43; 11; 15 | — |
| SECONDARY Patient Satisfaction - Question 3 |
34; 13; 57; 60; 12; 15 | — |
| SECONDARY Patient Satisfaction - Question 4 |
34; 17; 54; 52; 14; 16 | — |
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
Data sourced from ClinicalTrials.gov (NCT04338893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.