Osteoarthritis of the ShoulderNCT04468178
Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
A study testing Total joint arthroplasty of the glenohumeral joint in people with Osteoarthritis of the Shoulder, run by Hannover Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis of the Shoulder
- What is being tested?
- Total joint arthroplasty of the glenohumeral joint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 17 Sep 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
Hanover, Lower Saxony, 30625
Tomas Smith, PD Dr., +49 511 5354 ext. 310, tomas.smith@diakovere.de
Tomas Smith, PD Dr.
About this study
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).
Read the 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
- Being tested
- Total joint arthroplasty of the glenohumeral joint
- Keywords
- osteoarthritis, shoulder, joint replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total joint arthroplasty of the glenohumeral jointDevice
The arthroplasty of the glenohumeral joint will be performed as an anatomical reconstruction after primary or post-traumatic osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Total joint arthroplasty of the glenohumeral joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 months postoperative
Secondary outcomes (6)
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.
Measured: 3 months postoperative
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.
Measured: 12 months postoperative
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.
Measured: 24 months postoperative
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.
Measured: 3 months postoperative
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.
Measured: 12 months postoperative
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.
Measured: 24 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start17 Sep 2021
- Primary completion25 Jan 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized controlled mono-centric study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomas Smith, PD Dr., Principal investigator, Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468178
- Sponsor's protocol ID
- IIT-RSA-Global-Icon-2020
- Status last verified
- Mar 2025
- First submitted
- 30 Jun 2020
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
- ClinicalTrials.gov ID
- NCT04468178
- Acronym / sponsor ID
- IIT-RSA-Global-Icon-2020
- Conditions
- Osteoarthritis of the Shoulder
- Keywords
- osteoarthritis, shoulder, joint replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized controlled mono-centric study
| Arm | Type | Receives |
|---|---|---|
| Shoulder prosthesis system GLOBAL ICON from DePuy | Experimental | Device: Total joint arthroplasty of the glenohumeral jointThe 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. |
| SIMPLICITY shoulder prosthesis system from Wright Medical | Active comparator | Device: Total joint arthroplasty of the glenohumeral jointThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total joint arthroplasty of the glenohumeral jointThe arthroplasty of the glenohumeral joint will be performed as an anatomical reconstruction after primary or post-traumatic osteoarthritis. | Device | SIMPLICITY shoulder prosthesis system from Wright Medical, Shoulder prosthesis system GLOBAL ICON from DePuy |
Primary outcome
Constant-Murley Score (CMS)
Time frame: 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)
Time frame: 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)
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.
6 secondary outcomes
Oxford Shoulder Score (OSS)
Time frame: 3 months postoperative
Oxford Shoulder Score (OSS)
Time frame: 12 months postoperative
Oxford Shoulder Score (OSS)
Time frame: 24 months postoperative
Short Form Health 36 (SF-36)
Time frame: 3 months postoperative
Short Form Health 36 (SF-36)
Time frame: 12 months postoperative
Short Form Health 36 (SF-36)
Time frame: 24 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomas Smith, PD Dr. principal investigator
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total joint arthroplasty of the glenohumeral joint in people with Osteoarthritis of the Shoulder, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomas Smith, PD Dr. (+49 511 5354 310, tomas.smith@diakovere.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-Murley Score (CMS) (time frame: 3 months postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.