M16.1 M16.7
Conditions
Interventions
Group 1: Total hip arthroplasty using an optimys stem.
Clinical and radiological follow-up after 6 weeks, 6, 12, 24 months, 5 and 10 years.
Sub-group: Additional measurement of offset and leg lengt
Sponsors
Mathys Orthopädie GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patient shall: • suffer from primary or secondary coxarthrosis. One or more of the following pathologies/symptoms: coxarthrosis, dysplastic coxarthrosis, rheumatoid arthritis, necrosis of the head of the femur or posttraumatic coxarthrosis. • Be ready to participate in the follow-up examinations mentioned above • Be between 18 and 85 years old at the time of inclusion • Be a candidate for a primary implantation of a hip endoprosthesis • Be expected to recover completely Additional inclusion criteria for sub-group: • Implantation of a RM Pressfit vitamys Cup • Unilateral THA with healthy contralateral hip • X-ray must be analyzable
Exclusion criteria
Exclusion criteria: Patient may not: • Participate simultaneously in another clinical study or documentation with other orthopaedic implants of competitors. • Offer no guarantee for regular follow-up controls • Suffer from the exclusion criteria: sepsis or malignant tumours. • Have an ASA Classification > 3. • Have a revision surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harris Hip Score after 2 years is defined as Primary endpoint. However, the score is recorded in every follow-up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| i) EBRA Analysis ii) Detection of early loosening iii) Collection of complications. Retrospective EBRA Analysis is carried out after 2 and 5 years. Early loosening and complications are recorded at every follow-up visit. iv) Sub-group: reconstruction of offset and leg length (parameter measured on the first postoperative X-ray) | — |
Countries
Austria, Germany
Contacts
Public ContactNatividad Zeleny
Mathys Mathys Orthopädie GmbH
Outcome results
None listed