A post market clinical follow-up study with the Optimys Stem, with initial RSA analysis
Completed
- Conditions
- Hip ArthroplastyHip replacement10023213
- Registration Number
- NL-OMON47653
- Lead Sponsor
- Stichting SCORE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
• Suffer from primary or secondary 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
• Have a BMI of 35 or less
Exclusion Criteria
• Simultaneous participation in another clinical study or documentation with other orthopaedic implants of competitors.
• Suffer from the exclusion criteria: sepsis or malignant tumours.
• Have an ASA Classification > 3.
• Have a revision surgery
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>For the first part of the study the initial migration measured by RSA will be<br /><br>the primary outcome. For the whole PCMF the HOOS is the primary final outcome. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Additionally survival, complications and quality of life will be documented. </p><br>