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RecruitingNot ApplicableNCT04468178

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

Sponsor

Hannover Medical School

Enrollment

60 participants

Start Date

Sep 17, 2021

Study Type

INTERVENTIONAL

Conditions

Osteoarthritis of the Shoulder

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).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • Trial participants need primary total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis
  • Trial participants are willing to take part in the clinical trial and intend to be available for the planned follow-up examinations.
  • Male, female and various subjects with age on the day of surgery from 18 to 80 years inclusive.
  • Subjects agree not to participate in any other clinical trial for at least 2 years (+ 3 weeks) using the index procedure. This includes clinical trials of medication, invasive procedures and medical devices. Questionnaire-based studies or other studies that are non-invasive and do not involve drug use are allowed.
  • Exclusion of intraoperative circumstances that require the implantation of a prosthesis type other than that provided for in the clinical trial (depending on the surgeon).

Exclusion Criteria4

  • Previous operation on the rotator cuff of the affected shoulder
  • Dysfunctional rotator cuff
  • Infection of the affected shoulder joint or systemic infection
  • Pregnant or breastfeeding women and those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure

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Interventions

DEVICETotal 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.

Locations(1)

Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Hanover, Lower Saxony, Germany

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NCT04468178

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