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

Hannover Medical School1 site in 1 country60 target enrollmentSeptember 17, 2021

Overview

Brief 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).

Detailed Description

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). As secondary endpoints, the migration behavior of the humeral components over time will be determined by radiostereometric analysis (RSA), the further clinical-functional results and the satisfaction of the patients treated will be investigated. Clinical outcomes are measured using standardized and reproducible clinical scores (Oxford Shoulder Score -OSS and Short Form Health 36-SF-36 v1.0 ) at each time of examination. Other endpoints include revision rate within the follow-up period, surgical time (incision to suture), and delays in surgical procedures due to instrumentation. The times of data acquisition are the admission day before the operation to determine the preoperative status, the discharge day and the follow-up appointments after 3 months, 6 months, 12 months and 24 months to determine the postoperative status and course.

Registry

clinicaltrials.gov

Start Date

September 17, 2021

End Date

December 31, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hannover Medical School

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Outcomes

Primary Outcomes

Constant-Murley Score (CMS)

Time Frame: 24 months postoperative

The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.