Hip TEP
Conditions
Interventions
Group 1: monocentric, historical 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: 1. The written Informed Consent Form (ICF) is signed by the patient prior to any study- specific actions. 2. The patient is / was being operated at Agaplesion Diakonieklinikum Rotenburg gGmbH. 3.The patient will receive / has received the PE hip cup Müller II cemented in combination with the EcoFit® 133° hip stem cemented (manufactured by implantcast GmbH). 4. The implantation will be performed / was performed according to the following medical indications. - non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis, - post-traumatic osteoarthritis, - treatment of fractures that cannot be treated with other surgical techniques, - Rheumatoid Arthritis - Femoral head and neck fractures 5. 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.
Exclusion criteria
Exclusion criteria: - No informed consent form signed by the patient is available. - At the time of the follow-up examination, the patient has a tumor disease (not tumor-free in the last 5 years). - Obesity Class 3 (severe obesity, BMI = 40 kg/m2); WHO classification. - Currently existing infection. - Known allergy to one of the materials used. - At the time of consent prior to the planned surgery (prospectively), the patient has a pregnancy. For patients who have already undergone surgery, a pregnancy at the time of study participation is not an exclusion criterion. - 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, complications | — |
Countries
Germany
Contacts
Public ContactMax Daniel Kauther
Agaplesion Diakonieklinikum Rotenburg gGmbH
Outcome results
None listed