knee prosthesis Knee wear/osteoarthritis
Conditions
Interventions
Implantation of the Persona Partial Knee prosthesis, manufactured by Zimmer
Biomet (Warsaw, IN, USA).
Sponsors
Reinier Haga Orthopedisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Specific indications for Persona Partial Knee:* Noninflammatory degenerative joint disease (NIDJD), e.g. osteoarthritis, avascular necrosis * Traumatic arthritis * Previous tibial condyle or plateau fractures with loss of anatomy or function * Varus deformities * Revision of previous knee surgeries (Although this is an indication for the PPK, patients with previous UKP in the same compartment will not be included in this study. See *2.3 Exclusion criteria*)Subjects must additionally meet the following criteria to participate in this study: * Age >18 years * Patient is willing to participate * Patient is able to speak and write Dutch * Patient qualifies for UKP based on physical exam and medical history * Patient is able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: Subjects will be excluded when they meet one or more of the following contra-indications for the Persona Partial Knee:* Infection, sepsis, and osteomyelitis * Rheumatoid arthritis or other forms of inflammatory joint disease * Insufficiency of the collateral, anterior or posterior cruciate ligaments which would preclude stability of the device * Full thickness damage to the weight bearing area of the contralateral compartment * Uncooperative patient or patient with neurologic disorders who are incapable of following directions * Insufficient bone stock to provide adequate support and/or fixation to the prosthesis * Metabolic disorders which may impair bone formation * Osteomalacia * Distant foci of infections which may spread to the implant site * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * Vascular insufficiency, muscular atrophy, neuromuscular disease * Incomplete or deficient soft tissue surrounding the knee * Charcot*s disease * Fixed varus deformity (not passively correctable) or greater than 15 degrees * Fixed flexion deformity (not passively correctable) of greater than 15 degrees. Additionally, subjects will be excluded when they meet the following exlusion criteria:* 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 main study parameter is migration of both the tibial and femoral components of the prosthesis using mRSA, expressed as translations (mm) and rotations (degrees). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to analyze short- and midterm clinical results by means of numeric rating scale (NRS) for pain, range of motion (ROM), Knee injury and Osteoarthritis Outcome Score (KOOS-PS), Oxford Knee Score (OKS), Knee Society Score (KSS) EuroQoL-5D (EQ-5D), radiographic results and satisfaction. | — |
Countries
Netherlands
Outcome results
None listed