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

NCT04468178 | Recruiting

• 1 other identifier: IIT-RSA-Global-Icon-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis of the Shoulder

Keywords

osteoarthritis; shoulder; joint replacement

Outcome Measures

Primary Outcomes (3)

• Constant-Murley Score (CMS)

  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.

  3 months postoperative

• Constant-Murley Score (CMS)

  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.

  12 months postoperative

• Constant-Murley Score (CMS)

  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.

  24 months postoperative

Secondary Outcomes (6)

• Oxford Shoulder Score (OSS)

  3 months postoperative

• Oxford Shoulder Score (OSS)

  12 months postoperative

• Oxford Shoulder Score (OSS)

  24 months postoperative

• Short Form Health 36 (SF-36)

  3 months postoperative

• Short Form Health 36 (SF-36)

  12 months postoperative

Study Arms (2)

Shoulder prosthesis system GLOBAL ICON from DePuy

EXPERIMENTAL

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.

Device: Total joint arthroplasty of the glenohumeral joint

SIMPLICITY shoulder prosthesis system from Wright Medical

ACTIVE COMPARATOR

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.

Device: Total joint arthroplasty of the glenohumeral joint

Interventions

Total joint arthroplasty of the glenohumeral joint 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; Shoulder prosthesis system GLOBAL ICON from DePuy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Hanover, Lower Saxony, 30625, Germany

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Tomas Smith, PD Dr.

  Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Smith, PD Dr.

CONTACT

+49 511 5354 310; tomas.smith@diakovere.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized controlled mono-centric study

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 13, 2020
• Study Start: September 17, 2021
• Primary Completion: January 25, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)