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

NCT ID: NCT04468178

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2027-12-31

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.

Conditions

Osteoarthritis of the Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Shoulder prosthesis system GLOBAL ICON from DePuy

The GLOBAL ICON stemless is a shaftless shoulder prosthesis system for anatomical reconstruction of the shoulder joint in cases of total or hemiarthroplasty in the shoulder. The base plate consists of titanium coated with hydroxyapatite, the head of cobalt-chrome.

Group Type: EXPERIMENTAL

Total joint arthroplasty of the glenohumeral joint

Intervention Type: DEVICE

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

SIMPLICITY shoulder prosthesis system from Wright Medical

The SIMPLICITY is a shaftless shoulder prosthesis system for anatomical reconstruction of the shoulder joint in cases of total or hemiarthroplasty in the shoulder. The base plate consists of titanium coated with hydroxyapatite, the head of cobalt-chrome.

Group Type: ACTIVE_COMPARATOR

Total joint arthroplasty of the glenohumeral joint

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomas Smith, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Locations

Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Hanover, Lower Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Tomas Smith, PD Dr.

Role: CONTACT

tomas.smith@diakovere.de

+49 511 5354 310

Facility Contacts

Tomas Smith, PD Dr.

Role: primary

tomas.smith@diakovere.de

+49 511 5354 ext. 310

Other Identifiers

IIT-RSA-Global-Icon-2020

Identifier Type: -

Identifier Source: org_study_id