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Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder

NCT04468178 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-25

No results posted yet for this study

Summary

The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).

Conditions

  • Osteoarthritis of the Shoulder

Interventions

DEVICE

Total joint arthroplasty of the glenohumeral joint

The arthroplasty of the glenohumeral joint will be performed as an anatomical reconstruction after primary or post-traumatic osteoarthritis.

Sponsors & Collaborators

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Tomas Smith, PD Dr. · Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-17
Primary Completion
2024-01-25
Completion
2027-12-31

Countries

  • Germany

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 NCT04468178 on ClinicalTrials.gov