A post market clinical follow-up study with the short stem uncemented endoprosthesis (optimys )
- Conditions
- M16.1M16.7Other primary coxarthrosisOther secondary coxarthrosis
- Registration Number
- DRKS00014711
- Lead Sponsor
- Mathys Orthopädie GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 224
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
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Harris Hip Score after 2 years is defined as Primary endpoint. However, the score is recorded in every follow-up visit.
- Secondary Outcome Measures
Name Time Method i) EBRA Analysis<br>ii) Detection of early loosening<br>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)