M16.1 M16.7
Conditions
Interventions
Group 1: Total hip endoprosthesis with an optimys shaft, at a BMI over 40. Clinical and radiographic follow-up is performed after 6-12 weeks, 12, 24, 60 months.
Sponsors
Mathys Orthopädie GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The patient must: • have a BMI over 40 • the patient must sign his written consent • Primary implantation • suffer from primary or secondary coxarthrosis of the femoral head • Fractures or necrosis of the femoral head in these cases, a stable anchoring of the implant must be possible • Age at inclusion: between 18 and 75 years • Willingness to participate in the above-mentioned follow-up examinations
Exclusion criteria
Exclusion criteria: The patient is not allowed to: • have a known or suspected addiction (eg, drug or alcohol abuse) • Inclusion of the study doctor, his family, employees or other dependent persons • Missing consent form (not signed by the participant and / or the study doctor) • Patients younger than 18 years • Revision operations • Presence of sepsis or malignant tumor / tumors • femoral fractures • No dysplasia with a sharp femoral neck • ASA classification <3 • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 5 years, the following shall also be measured and evaluated: • A retrospective analysis of the X-rays using EBRA-FCA for the evaluation of the stem migration. • According to the evaluation of the Gruen Zones early loosening of the implants should be detected as soon as possible and evaluated. • Systematic collection of possible complications. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Harris Hip Score (HHS) and the SF36 are the secondary final point of the study. The follow-ups shall be performed after 6–12 weeks, 1 year, 2 years and 5 years. | — |
Countries
Germany
Contacts
Public ContactNatividad Zeleny
Mathys Orthopädie GmbH
Outcome results
None listed