PROMOS - Patient benefit from the new modular shoulder prosthesis

Withdrawn

• Conditions: Degenerative shoulder disease; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12609000795291
• Lead Sponsor: Smith&Nephew Surgical Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Primary or secondary omarthrosis as an indication for primary total shoulder arthroplasty
2. Massive rotator cuff rupture

Exclusion Criteria

Patients with the following critieria will be not eligible to participate in the study.

1. Previous ipsilateral shoulder arthroplasty
2. Late stage rotator cuff disease (Only for PROMOS standard prosthesis)
3. Acute shoulder trauma
4. General medical contraindication to surgery
5. Legal incompetence
6. Tumour / malignoma
7. Recent history of substance abuse
8. Any disease process that would preclude accurate evaluation (e.g.
neuromuscular, psychiatric or metabolic disorder)
9 Known hypersensitivity to the materials used
10. Bacterial infection at the time point of operation

Study & Design

• Study Type: Interventional
• Study Design: Not specified