M17.1
Conditions
Interventions
Group 1: Participants in the study will undergo uncemented implantation of a Triathlon Knee System total knee arthroplasty (KTEP) using the Stryker MAKO robotic system. Clinical scores commonly used i
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Male or female patients aged = 18 years. - Primary gonarthrosis with indication for implantation of a KTEP - UCLA score = 4 (activity score)
Exclusion criteria
Exclusion criteria: - Condition after previous bony operations or injuries in/on the knee joint (conversion osteotomies, intra-articular fractures) - Condition after anterior and posterior cruciate ligament reconstruction - BMI > 40 - Ligamentous instability of the collateral ligaments or the cruciate ligaments - Condition after joint infection or existing systemic inflammatory disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the Oxford Knee Score (OKS) of the uncemented implant after 2 years, the non-inferiority of which will be shown compared to an already clinically established cemented procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Recording of surgery-specific parameters (incision-suture time, blood loss, postoperative transfusion requirements) - Recording of early complications, revision rate, implant survival - Examination of the native radiological images during the course of the operation for early signs of loosening ("radio lucent lines") and recording of the positioning and position of the prostheses in a group comparison. | — |
Countries
Germany
Contacts
Public ContactYvonne Noll
Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift, Leitung Klinisches Studienmanagement
Outcome results
None listed