degenerative joint disease Osteoarthritis
Conditions
Interventions
None listed
Sponsors
Reinier Haga Orthopedisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Indication for medial unicompartmental knee replacement mainly as a result of moderately disabling joint disease because of: Painful osteo- or post-traumatic arthitis or as an alternative to tibial osteotomy. - Patient qualified for UKP based on physical exam and medical history - Patient is able to speak and write Dutch - Patient is willing to participate and able to provide written informed consent - Age > 18 years
Exclusion criteria
Exclusion criteria: - contraindication as described by the manufacturer - patient has a known or suspected sensitivity or allergy to one or more of the implant materials - revision UKP surgery of the same compartment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The migration of the Restoris MCK of both the tibial and femoral component calculated as translation (mm) and rotation (degrees) measured with mRSA. Furthermore, the stability of the markers will be determined and the complications due to the markers and/or marker inserter will be registered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival of the Restoris MCK, short and long term clinical scores of pain (NRS), function (Knee Society Score (KSS), Range of Motion, ROM) and the Knee injury and Osteoarthritis Outcome Score (KOOS-PS), Oxford Knee Score (OKS), EuroQoL-5D (EQ-5D-5L), Forgotten Joint Score (FJS), satisfaction and radiographic aspects (both x-ray and CT scan). | — |
Countries
Netherlands
Outcome results
None listed