Shoulder osteoarthritis, Arthroplasty, Prosthesis, implant technical complications, Radio Stereometric Analysis
Conditions
Interventions
Placement of the Simpliciti stemless humeral component prosthesis, with insertion of tantalum beads for radiosteraophotogrammetric analysis (RSA).
Sponsors
Department of orthopaedic surgery, Reinier de Graaf Groep
Eligibility
Inclusion criteria
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. - Patients willing to participate. - Speaking and writing Dutch language. - Patients with either osteoarthritis, traumatic arthritis, rheumatoid arthritis of the glenohumeral joint or necrosis of the humeral head. - Indication for shoulder replacement (Larsen grade 4 or 5, invalidating pain). - Patients able to provide written informed consent.
Exclusion criteria
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. - Patients with BMI > 35. - Any active infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is: - fixation and migration of the Simplicti (Tornier, France) stemless humeral component in vivo using model based radiostereophotogrammetric (mRSA) analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary parameters are: - 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. | — |
Contacts
Public ContactN.M.C. Mathijssen
Reinier de Graafweg 3-11
Outcome results
None listed