Fixation of the Simpliciti stemless humeral component, a radio-stereophotogrammatic analysis

Completed

• Conditions: shoulder prosthesis; Shoulder wear/artritis; 10005944

• Registration Number: NL-OMON50468
• Lead Sponsor: Reinier Haga Orthopedisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion 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

•Patients with osteonecrosis (except the necrosis of the humeral head),
fractures, (post-)septic arthritis, instability.
•Patients with BMI>35
•Any active infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>fixation and migration patterns of the Simplicity (Tornier, France) stemless<br /><br>humeral component in vivo using model based radiostereophotogrammetric (mRSA)<br /><br>analysis</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the mid and long term clinical results (NRS for pain, Range of<br /><br>motion, Constant score, SF-12, Dash, Oxford Shoulder score and radiographs) in<br /><br>an on-going follow-up, and correlate the clinical results to the RSA migration<br /><br>data.</p><br>