Fixation of the Simpliciti stemless humeral component, a radio-steophotogrammatic analysis
Completed
- Conditions
- Shoulder osteoarthritis, Arthroplasty, Prosthesis, implant technical complications, Radio Stereometric Analysis
- Registration Number
- NL-OMON26001
- Lead Sponsor
- Department of orthopaedic surgery, Reinier de Graaf Groep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Aged 45 years and older.
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients with osteonecrosis (except the necrosis of the humeral head), fractures, (post-)septic arthritis, instability.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is:<br /><br>- fixation and migration of the Simplicti (Tornier, France) stemless humeral component in vivo using model based radiostereophotogrammetric (mRSA) analysis.
- Secondary Outcome Measures
Name Time Method The secondary parameters are:<br /><br>- To evaluate the mid and long term clinical results in an on-going follow-up, and correlate the clinical results to the RSA migration data. The clinical results will be measured by: NRS for pain, Range of Motion, Constant Score, SF-12, DASH, Oxford Schoulder Score and radiographs.