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

NCT04468178 · tracked via the Priya Life Science Germany tracker

Sponsor

Hannover Medical School

Phase

Not applicable

Started

2021-09-17

Last updated

2025-03-25

Condition(s) studied

Osteoarthritis of the Shoulder

Investigational drug(s) / intervention(s)

Total joint arthroplasty of the glenohumeral joint

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.

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Trial participants need primary total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis 2. Trial participants are willing to take part in the clinical trial and intend to be available for the planned follow-up examinations. 3. Male, female and various subjects with age on the day of surgery from 18 to 80 years inclusive. 4. 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. 5. 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: 1. Previous operation on the rotator cuff of the affected shoulder 2. Dysfunctional rotator cuff 3. Infection of the affected shoulder joint or systemic infection 4. Pregnant or breastfeeding women and those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure

Primary outcome measure(s)

Constant-Murley Score (CMS) — 3 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.
Constant-Murley Score (CMS) — 12 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.
Constant-Murley Score (CMS) — 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.

Trial sites (1)

Facility	City	Region	Status
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift	Hanover	Lower Saxony	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04468178 on ClinicalTrials.gov ↗ ← All trials in Germany