DRKS00023167
Suspended
Not Applicable
Clinical testing of a new, CE-certified joint mechanism (MUTARS® HD coupling C-O-M) for the implantation of a tumour or revision prosthesis in the area of the knee joint - MUTARS HD C-O-M
niversitätsklinikum Essen0 sites175 target enrollmentOctober 19, 2020
ConditionsEvaluation of a CE-certified coupling mechanism (MUTARS HD coupling C-O-M) in case of implantation of a tumor- or revision-prosthesis in the kneeC41.9D16.2T84.0T84.5Bone and articular cartilage, unspecifiedLong bones of lower limbMechanical complication of internal joint prosthesisInfection and inflammatory reaction due to internal joint prosthesis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- 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
- Sponsor
- niversitätsklinikum Essen
- Enrollment
- 175
- Status
- Suspended
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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