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Clinical Trials/ACTRN12609000795291
ACTRN12609000795291
Withdrawn
Not Applicable

A prospective, multicentre, cohort study evaluating patient benefit after primary total shoulder arthroplasty with the modular PROMOS shoulder system.

Smith&Nephew Surgical Pty Ltd0 sites240 target enrollmentSeptember 15, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Smith&Nephew Surgical Pty Ltd
Enrollment
240
Status
Withdrawn
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 15, 2009
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Smith&Nephew Surgical Pty Ltd

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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