bewegingsapparaat arthroplasty osteoarthritis prostheses
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: This study is focused on patients treated with the Vanguard PS Open Box Porous Femoral between 2009 and 2013 within the Amsterdam UMC, location AMC. The Vanguard PS Open Box Porous Femoral prosthesis is indicated for patients treated for: • Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. • Correction of varus, valgus, or posttraumatic deformity. • Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. Additionally, in order to be eligible to participate in this study, a subject must meet the following criteria: • The participant must be able to understand the Dutch language in order to complete the questionnaires.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Off label use. Absolute contraindications include: • Infection. • Sepsis. • Osteomyelitis. Relative contraindications include: • An uncooperative patient or a patient with neurologic disorders who is incapable of following directions. • Osteoporosis. • 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, and/or incomplete or deficient soft tissue surrounding the knee. Subgroup exclusion criteria: • For the subgroup analysis to determine variability in methodological error, bilateral patients are excluded from the subgroup since they will already be exposed to an additional scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of safety by recording and analyzing the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance and clinical benefits demonstrated by PROMs (patient-reported out-come measures). Radiographic Outcomes from conventional X-rays and evaluation of induced micro motion using CT-scans and valgus-varus loading of the knee joint. | — |
Countries
Netherlands
Outcome results
None listed