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Safety Study of Univers® Revers Shoulder Prosthesis

NCT01778777 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2023-04-18

No results posted yet for this study

Summary

The primary safety objective is to demonstrate that severe device-related complication (Serious Adverse Device Effect = SADE) occur within 2 years after prosthesis implantation at a rate of less than 2%. Such adverse events include (but are not limited to) revisions due to dislocation or glenoid loosening, septic arthritis and scapular fractures requiring surgical repair.

Conditions

  • Rotator Cuff Tear Arthropathy

Interventions

DEVICE

Universe Reverse Prosthesis

Implantation of an universe reverse prosthesis

Sponsors & Collaborators

  • Arthrex, Inc.

    collaborator INDUSTRY

  • Schulthess Klinik

    lead OTHER

Principal Investigators

  • Hans-Kaspar Schwyzer, Dr. · Schulthess Klinik

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-01
Primary Completion
2019-06-01
Completion
2023-04-15

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01778777 on ClinicalTrials.gov