degenerative joint disease knee osteoarthritis
Conditions
Interventions
The study intervention is the hybrid fixation of Legion revision TKA with cones
as used in regular clinical practice.
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Patients requiring a (re-(re-))revision of their total knee arthroplasty and the Legion system with the use of a cone in the tibia because of metaphyseal bone loss. • Patient is willing to consent to participate in the study. • Patient is
Exclusion criteria
Exclusion criteria: • Indication for a hinged-type revision system. • Active, local infection or systemic infection. • Patient has physical, emotional, or neurological conditions that would compromise the patient*s compliance with postoperative rehabilitation and follow-up. • Patient has an immunosuppressive disorder (including inflammatory arthritis). • Patient has a known sensitivity to materials in the device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the stability of the revision construct with cones at two and five years. Stability is measured and will be described by migration of the implant with regard to the (RSA markers in the) bone. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secundary endpoint is the survival of the revised TKA system. Additionally, clinical and functional performance will be evaluated. | — |
Countries
Netherlands
Outcome results
None listed