Evaluation of a CE-certified coupling mechanism (MUTARS HD coupling C-O-M) in case of implantation of a tumor- or revision-prosthesis in the knee C41.9 D16.2 T84.0 T84.5
Conditions
Interventions
Group 1: The study includes patients for which a tumour prosthesis of the proximal tibia or the type MUTARS® total knee, as well as MUTARS® distal femur, needs to be implanted. Furthermore, patients a
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients for which a tumour prosthesis of the proximal tibia or the type MUTARS® total knee, as well as MUTARS® distal femur, needs to be implanted. Indication for tumorresection and reconstruction is also given within the sarcoma-tumor-conference. 1.Patients are included for which a replacement operation to a revision endoprosthesis type GenuX® MK or KRI or instead to the systems MUTARS® proximal tibia or MUTARS® femur is necessary due to failure (e.g. infection, loosening, perioperative fracture) of a previously implanted knee endoprosthesis.
Exclusion criteria
Exclusion criteria: Patients without any indication for implantation of tumor prosthesis (decision of tumor conference) in case of sarcoma or metastasis. Furthermore excluded are patients without any need to implant an axis-guided prosthesis in case of revision surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival (prosthesis) Clinical surveillance of the long-term stability (5 to 10 years) of implanted prostheses with MUTARS PEEK HD coupling. Target figures: - Functional outcome - mobility (active/passive) of the knee - OKS (Oxford Knee Society) score - MSTS (Musculoskeletal Tumor Society)-Enneking score - complications: - periprosthetic infection - aseptic loosening - failure/malfunction of the coupling - wound healing disorder - overall condition of the distal extremity | — |
Countries
Germany
Outcome results
None listed