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

Osteoarthritis of the Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04468178
• Other study ID #: IIT-RSA-Global-Icon-2020
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Hannover Medical School
• Contact: Tomas Smith, PD Dr.
• Phone: +49 511 5354 310
• Email: tomas.smith[@]diakovere.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Shoulder

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift	Hanover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Oxford Shoulder Score (OSS)	The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.	3 months postoperative
Secondary	Oxford Shoulder Score (OSS)	The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.	12 months postoperative
Secondary	Oxford Shoulder Score (OSS)	The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.	24 months postoperative
Secondary	Short Form Health 36 (SF-36)	The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	3 months postoperative
Secondary	Short Form Health 36 (SF-36)	The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	12 months postoperative
Secondary	Short Form Health 36 (SF-36)	The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	24 months postoperative