Hip TEP
Conditions
Interventions
Group 1: monocentric, prospective PMCF study
assessments:
revision rate incl. reasons for revision
Sponsors
implantcast GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
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. Franziskus-Hospital. • The patient will receive the EcoFit® Hip System (manufactured by implantcast GmbH). • The implantation will be performed according to the medical indications. • 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 signed by the patient is available. • The patient has a tumor at the time of the PMCF visit. • The female patient is planning a pregnancy or is pregnant. • The patient is a minor, 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 assess the nature and scope of the study. • The patient has participated in another clinical study within the last four weeks before enrolment in this PMCF study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Function | — |
Countries
Germany
Contacts
Public ContactImke Bokelmann
implantcast GmbH
Outcome results
None listed