Patients with bone tumors
Conditions
Interventions
In all participating centers, patients will be treated according to standard care. The choice for the use of a CFR PEEK implant will be as is standard for the participating surgeon.
Sponsors
LUMC
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this registry, a patient must meet all of the following criteria. The patient: • Is aged 18 years or older • Has received or will receive a CFR PEEK implant • Is diagnosed with either a primary bone tumor, metastatic bone lesion, soft-tissue sarcoma, benign bone tumor or multiple myeloma.
Exclusion criteria
Exclusion criteria: A potential patient who meets any of the following criteria will be excluded from participation in this study: • Metabolic bone disease • History of Paget’s disease or other osteodystrophy’s whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism, hyperparathyroidism, Ehrler’s- Danlos-syndrome, osteogenesis imperfecta, achondroplasia, tuberculosis. • History of mental disorder or current psychiatric treatment. • Infection in the location of the operative site, discitis, osteomyelitis, fever and/or leukocytosis (as diagnosed based on the results of CBC and ESR tests). • Lack of willingness to make a commitment to return for required follow-up visits. • Drug and/or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the implant safety of CFR PEEK implants in patients with bone tumors using the complication rate according to the Henderson classification at 6 months, 1, 2, 5 and 10 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine risk factors for complications | — |
Contacts
Public ContactZeger Rijs
LUMC
Outcome results
None listed