Primary knee osteoarthritis with indication for primary total knee arthroplasty M17.0
Conditions
Interventions
Group 1: Robotic-assisted mechanical alignment (RA-MA):
Primary total knee arthroplasty using the VELYS™ Robotic-Assisted Solution with mechanical alignment
operative strategy: tibia-first.
Group 2: Robotic-assisted kinematic alignment (RA-KA):
Primary total knee arthroplasty using the VELYS™ Robotic-Assisted Solution with kinematic alignment
operative strategy: femur-first.
Group 3: Manual mechanical alignment (MA):
Primary total knee arthroplasty using conventional manual instrumentation with mechanical alignment according to established
operative strategy: tibia-first.
Sponsors
St. Marienkrankenhaus Ludwigshafen, Klinik für Orthopädie und Unfallchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Primary knee osteoarthritis with indication for primary total knee arthroplasty; capacity to consent and written informed consent; willingness and ability to complete patient-reported outcome assessments; availability of routine preoperative imaging.
Exclusion criteria
Exclusion criteria: Revision procedures, unicompartmental or simultaneous bilateral total knee arthroplasty; active infection, tumor disease, or recent fracture; inflammatory rheumatic systemic disease; pregnancy or breastfeeding; insufficient German language skills, inability to consent, or lack of follow-up reachability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxford Knee Score (OKS); assessed at 12 months postoperatively; data collection by OKS questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional: Oxford Knee Score (OKS) at 3 and 24 months; Forgotten Joint Score-12 (FJS-12) at 12 and 24 months; EQ-5D-5L preoperatively and at 3, 12, and 24 months; knee range of motion (ROM) at 3 months during routine clinical follow-up. Radiographic: mHKA/HKA, MAD, and aFTA/FTA; assessed preoperatively within = 3 months before surgery and postoperatively within = 6 weeks after surgery using routine standing AP long-leg radiographs, with standardized SOP-based measurement. Perioperative / care-related: operative time, soft-tissue release (yes/no), and length of stay (LOS). PROMs (OKS, FJS-12, EQ-5D-5L) are collected using standardized questionnaires; ROM is assessed clinically, radiographic parameters are derived from routine imaging, and perioperative care parameters are obtained from routine clinical documentation. | — |
Countries
Germany
Contacts
Public ContactJohannes Stöve
St. Marienkrankenhaus Ludwigshafen, Klinik für Orthopädie und Unfallchirurgie
Outcome results
None listed