Total knee replacement (TKR)
Conditions
Interventions
Group 1: Post-Market Clinical Follow-up (PMCF) Study – Single-arm, Bi-centric, Controlled Historical-Prospective Observational Design.
Examinations / Data Collection:
Revision documentation including
joint function, quality of life
radiological evaluation if X-rays are available.
No X-rays will be taken as part of this study. Only X-rays obtained during routine examinations will be evaluated.
Observation Period / Visits per Pat
Sponsors
implantcast GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. The patient is/was operated on at the following hospitals: - University Hospital Essen - Orthopaedic Clinic Volmarstein 2. Patients in whom a tumor prosthesis or revision prosthesis of the proximal tibia or the MUTARS® Total Knee or MUTARS® Distal Femur type is planned to be implanted or has already been implanted. The indication for tumor resection and reconstruction is also determined in the sarcoma tumor board. 3. The MUTARS® HD Coupling C-O-M with safety plug from implantcast GmbH is/was implanted as a system component of a tumor prosthesis - for the replacement of the proximal part of the lower leg (MUTARS® Proximal Tibia) - for the types MUTARS® Total Knee and MUTARS® Distal Femur 4. Patients who required or require revision surgery with implantation of a revision endoprosthesis of type GenuX® MK or KRI, or the MUTARS® Proximal Tibia or MUTARS® Distal Femur systems, due to failure of a previously implanted total knee prosthesis. 5. Patients who have undergone or are planned to undergo revision surgery with a change to MUTARS® HD C-O-M with safety plug, without replacement of the bone-anchored components. 6. Willingness to respond to telephone inquiries or to participate in interviews conducted on-site at the hospital or in a clinical practice. 7. Written informed consent from the patient has been obtained following appropriate patient information prior to the follow-up examination.
Exclusion criteria
Exclusion criteria: 1. No informed consent has been obtained from the patient. 2. The patient is pregnant at the time of giving consent prior to the planned surgery (prospective inclusion). For female patients who have already undergone surgery, pregnancy at the time of follow-up is not an exclusion criterion. 3. Patient age over 99 years at the time of inclusion in the study. 4. Patient age under 18 years at the time of inclusion in the study. 5. Known allergy to any of the materials used. 6. Morbid obesity (BMI = 40 kg/m²), as defined by the WHO. 7. The patient is a minor, legally incapable of giving consent, and/or has limited legal capacity. 8. There are indications that the patient is unlikely to comply with the study protocol (e.g. lack of willingness to cooperate). 9. Participation in another interventional clinical trial within the last 4 weeks prior to inclusion, which – in the judgment of the investigator at the respective study site – could significantly influence the results of the implantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the Safety of the MUTARS® HD Coupling C-O-M with Safety Plug. Primary Endpoint: Revision Rates | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the Performance of the MUTARS® HD Coupling C-O-M with Safety Plug. Documentation of Complications. | — |
Countries
Germany
Contacts
Public ContactJendrik Hardes
Universitätsklinikum Essen
Outcome results
None listed