Knee TEP
Conditions
Interventions
Group 1: PMCF study (monocentric, prospective, non-interventional, single-armed)
data:
revisions incl. reasons, complications, joint function, quality of life, radiological evaluation (if X-rays avai
Sponsors
implantcast GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - The written Informed Consent Form (ICF) is signed by the patient prior to any study-specific actions. - The patient will be operated at the St. Josef hospital Werden. - The patient will receive the 5C® MEDic Knee System (manufactured by implantcast GmbH). - The implantation will be performed according to the medical indications listed in the product-specific Instruction for Use (IFU). - The patient is willing and able to attend the follow-up visits at the study site (clinics / hospital) and agrees to be contacted by telephone or by mail.
Exclusion criteria
Exclusion criteria: - No Informed Consent Form (ICF) signed by the patient is available - The patient has a tumor at the time of the examination (not tumor-free in the last 5 years). - Adipositas permagna - age > 99 years at enrolment - Current infection as well as infections close to the knee joint within the last 3 years - Known allergy to any of the implant materials - The female patient is pregnant at time of the implantation. - The patient is a minor (skeletally immature), incapable of giving consent, legally incompetent, or limited in his legal capacity. - There are indications that the patient will not comply with the study protocol. - Alcohol and/or drug abuse or other addictions that might impair the patient’s capacity to estimate the nature and the scope of the study - The patient participated in another clinical study within the last four weeks before inclusion in this PMCF study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the clinical safety of the 5C® MEDic knee system based on the revision rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the clinical performance of the 5C® MEDic knee system | — |
Countries
Germany
Contacts
Public ContactImke Bokelmann
implantcast GmbH
Outcome results
None listed