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Clinical Trials/DRKS00017483
DRKS00017483CompletedNot Applicable

A prospective PMCF multicentre study analysing performance and safety outcome of the Affinis Glenoid vitamys uncemented in total shoulder arthroplasty

Mathys AG Bettlach0 sites75 target enrollmentStarted: July 26, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
75

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 Years to one (—)
Sex
All

Inclusion Criteria

  • Informed consent form (signed by participant and investigator)
  • - Primary implantation
  • - Primary osteoarthritis, secondary osteoarthritis, fracture sequelae, avascular
  • necrosis of the humeral head
  • - Age at inclusion >18 years
  • - Intact rotator cuff
  • - Preoperative Constant Score >20 points
  • - Glenoid <15° retroversion and <70% humeral head subluxation

Exclusion Criteria

  • -Missing consent
  • - Rheumatoid arthritis
  • - Known or suspected non-compliance (e.g. drug or alcohol abuse)
  • - Revision surgery
  • - Presence of sepsis or malignant tumours
  • - Chemotherapy treatment within 6 months before surgery
  • - >5mg/day of corticosteroids, excluding inhalers, within 3 months before surgery
  • - Women who are pregnant or breast feeding

Investigators

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