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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50468

Enrollment

Registered

2014-02-21

Start date

2014-03-20

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

shoulder prosthesis Shoulder wear/artritis

Interventions

The Simpliciti shoulder prosthesis used in primary total shoulder arthroplasty.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: •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
fixation and migration patterns of the Simplicity (Tornier, France) stemless humeral component in vivo using model based radiostereophotogrammetric (mRSA) analysis	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)