Rotator Cuff TearsSiDNCT05868148
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
An observational study of Rotator Cuff Tears and Rheumatoid Arthritis Shoulder, run by Stryker Trauma and Extremities at 5 sites in United States.
Trial summary
The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears, Rheumatoid Arthritis Shoulder, Osteoarthritis Shoulder
- What is being tested?
- Shoulder iD™ Primary Reversed Glenoid
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Oct 2023to Dec 2035
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The intended patient population are adult patients who have reached skeletal maturity, with a functional deltoid muscle, and massive and non-repairable rotator cuff tear within one or more indications and zero contraindications with pain disabled by: * Rheumatoid arthritis * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) * Correction of functional deformity * Fractures of the humeral head * Traumatic arthritis * Revision of glenohumeral joint if sufficient native glenoid bone remains
Who may be able to join
- 18 years or older at the time of the informed consent or non-opposition (when applicable).
- Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
- Willing and able to comply with the requirements of the study protocol.
- Considered a candidate for shoulder arthroplasty using a study device.
- Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements
Who cannot join
- Patients who are not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times).
- Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred to as a "vulnerable subject" in section 3.44 of the ISO 14155:2020).
- Active local or systemic infection, sepsis, or osteomyelitis
- Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid (reassessed at time of surgery)
- Significant injury to the brachial plexus
- Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the device components
- Neuromuscular disease (e.g., joint neuropathy) Known allergy to one of the product materials
- Metabolic disorders which may impair bone formation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Jameson Crane Sports Medicine Institute OSU
Columbus, Ohio, 43202
UT Southwestern
Frisco, Texas, 75033
UT Health Science center - Houston
Houston, Texas, 77030
Carilion Clinic
Roanoke, Virginia, 24014
UCSF
San Francisco, California, 94158
About this study
The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device. The study will learn about standard device use in adult patients who have a functional deltoid muscle and massive and non-repairable rotator cuff tear. The main questions it aims to answer are:
- What is the average improvement in patient-reported shoulder function after 2 years when compared to before the surgery, and
- What is the rate of surgical revisions needed over a 10 year period
Patients will be asked to will be asked to regularly attend their check-up visits with their surgeon (including having x-rays or CT images taken to check their shoulder and implant), to complete questionnaires to report how their shoulder is doing, and to tell their surgeon when they notice any changes.
Read the detailed description
The Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is a Global, single arm, multicenter, prospective, non-significant risk Post-Market Clinical Follow-up (PMCF) study, designed to collect safety and performance data on designated commercially available Shoulder iD™ Primary Reversed Glenoid.
The objective of this multicenter study is to collect clinical data at baseline, surgery, immediate post-op, and annually through 10 years post-operation, on related clinical complications and clinical outcomes of market-approved Shoulder iD™ Primary Reversed Glenoid, to demonstrate safety and performance of these implants in a real-world setting.
The primary outcome measure is the average improvement in American Shoulder and Elbow Surgeons (ASES) score from baseline to 24 months.
Secondary outcome measures include the following assessments to be evaluated throughout the patient's participation in the study:
- Constant Score (years 1, 2, 5 and 10 only)
- Single Assessment Numeric Evaluation (SANE) Score
- Patient Satisfaction
- EQ-5D-5L
Radiologic imaging: Patient images (X-ray or CT) completed at baseline and in-person follow-ups will be analyzed for standard radiographic findings, including, but not limited to: device migration, component breakage, radiolucencies and bone characteristics.
Revision rate and survivorship will be assessed annually and at any time upon request for regulatory purposes such as PMCF or Clinical Evaluation Report (CER) updates. The cumulative incidence of device revisions and reoperations will be reported as well as Kaplan-Meier estimates for implant survival.
Adverse events will be evaluated from inclusion to last follow-up and will be documented during the study and categorized as whether they are serious and whether they are related to the Sponsor device or implant procedure.
During the study, patients will undergo the following procedures, which are standard of care:
- Patient information and Consent (as applicable per local regulation),
- Inclusion/non-inclusion criteria,
- Demography, Height \& Weight,
- Surgical history and relevant medical history,
- Physician exams (Range of Motion and Strength measurements),
- Patient questionnaires (ASES, Constant, SANE, Patient Satisfaction, EQ-5D-5L),
- Shoulder study implant \& surgery related data,
- CT scans, x-rays
- AE / SAE collection (continuous recording).
- Conditions
- Rotator Cuff Tears, Rheumatoid Arthritis Shoulder, Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus, Fracture, Humeral, Traumatic Arthritis of Right Shoulder Region (Diagnosis)
- Being tested
- Shoulder iD™ Primary Reversed Glenoid
- Keywords
- Massive RCT, Non-repairable RCT, Glenohumeral joint
- Medical subject headings
- Rotator Cuff Injuries, Humeral Fractures, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder iD™ Primary Reversed GlenoidDevice
Also called Patient-Matched Primary Reversed Glenoid
Device implant via reversed total shoulder arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Shoulder iD device implant | Adult patients who have reached skeletal maturity, with a functional deltoid muscle, and massive and non-repairable rotator cuff tear within one or more indications and zero contraindications who will receive the Shoulder iD Primary Reversed Glenoid device to replace the shoulder joint. Receives: Device: Shoulder iD™ Primary Reversed Glenoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance: change in functional ability of the treated shoulder
The average change in functional ability as measured by the American Shoulder and Elbow Surgeons (ASES) score. ASES is an absolute score ranging from 0 to 100 where a higher score indicates better shoulder function.
Measured: from baseline to 24 months
Safety: Revision rate and device survivorship
The cumulative incidence of device revisions and reoperations
Measured: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Secondary outcomes (5)
Performance: change in level of pain and ability to carry out normal daily activities of the patient
Assessed via the Constant-Murley Shoulder score collected at baseline, years 1, 2, 5 and 10 and any other standard collection timepoint. In this score, 35 points are allocated for subjective assessments of pain and activities of daily living and 65 points are available for objective measures of rage of movement and shoulder strength. A score of 100 is a healthy shoulder.
Measured: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Performance: change in patient self-assessment of current status of their treated shoulder
Assessed via the Single Assessment Numeric Evaluation (SANE) score collected from patients via ePRO at baseline, 3 months, and annually. The rating is from 0% to 100% with 100% being normal.
Measured: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Performance: change in patient self-rated quality of life
Assessed via EQ-5D-5L Five Dimensions Quality of Life measurement general health questionnaire collected from patients via ePRO at baseline, 3 months and annually. Each dimension is measured on 5 levels from 1 being no problems to 5 being extreme problems.
Measured: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Performance: change in patient satisfaction with their shoulder
Satisfaction rating collected from patients via ePRO at baseline, 3 months and annually. Rating options are: Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied.
Measured: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Safety: Adverse Event rate and assessments
Cumulative incidence of procedure and/or device related events (ADE, AESI, SAE, SADE)
Measured: from date of treatment until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start20 Oct 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Gibson, Study director, Stryker Trauma and Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868148
- Sponsor's protocol ID
- UE-02-2021
- Acronym
- SiD
- Status last verified
- Jan 2026
- First submitted
- 21 Apr 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
- ClinicalTrials.gov ID
- NCT05868148
- Acronym / sponsor ID
- SiD / UE-02-2021
- Conditions
- Rotator Cuff Tears, Rheumatoid Arthritis Shoulder, Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus, Fracture, Humeral, Traumatic Arthritis of Right Shoulder Region (Diagnosis)
- Keywords
- Massive RCT, Non-repairable RCT, Glenohumeral joint
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 22 May 2023 (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 goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device. The study will learn about standard device use in adult patients who have a functional deltoid muscle and massive and non-repairable rotator cuff tear. The main questions it aims to answer are:
- What is the average improvement in patient-reported shoulder function after 2 years when compared to before the surgery, and
- What is the rate of surgical revisions needed over a 10 year period
Patients will be asked to will be asked to regularly attend their check-up visits with their surgeon (including having x-rays or CT images taken to check their shoulder and implant), to complete questionnaires to report how their shoulder is doing, and to tell their surgeon when they notice any changes.
Detailed description
The Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is a Global, single arm, multicenter, prospective, non-significant risk Post-Market Clinical Follow-up (PMCF) study, designed to collect safety and performance data on designated commercially available Shoulder iD™ Primary Reversed Glenoid.
The objective of this multicenter study is to collect clinical data at baseline, surgery, immediate post-op, and annually through 10 years post-operation, on related clinical complications and clinical outcomes of market-approved Shoulder iD™ Primary Reversed Glenoid, to demonstrate safety and performance of these implants in a real-world setting.
The primary outcome measure is the average improvement in American Shoulder and Elbow Surgeons (ASES) score from baseline to 24 months.
Secondary outcome measures include the following assessments to be evaluated throughout the patient's participation in the study:
- Constant Score (years 1, 2, 5 and 10 only)
- Single Assessment Numeric Evaluation (SANE) Score
- Patient Satisfaction
- EQ-5D-5L
Radiologic imaging: Patient images (X-ray or CT) completed at baseline and in-person follow-ups will be analyzed for standard radiographic findings, including, but not limited to: device migration, component breakage, radiolucencies and bone characteristics.
Revision rate and survivorship will be assessed annually and at any time upon request for regulatory purposes such as PMCF or Clinical Evaluation Report (CER) updates. The cumulative incidence of device revisions and reoperations will be reported as well as Kaplan-Meier estimates for implant survival.
Adverse events will be evaluated from inclusion to last follow-up and will be documented during the study and categorized as whether they are serious and whether they are related to the Sponsor device or implant procedure.
During the study, patients will undergo the following procedures, which are standard of care:
- Patient information and Consent (as applicable per local regulation),
- Inclusion/non-inclusion criteria,
- Demography, Height \& Weight,
- Surgical history and relevant medical history,
- Physician exams (Range of Motion and Strength measurements),
- Patient questionnaires (ASES, Constant, SANE, Patient Satisfaction, EQ-5D-5L),
- Shoulder study implant \& surgery related data,
- CT scans, x-rays
- AE / SAE collection (continuous recording).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder iD device implant | – | Device: Shoulder iD™ Primary Reversed GlenoidAdult patients who have reached skeletal maturity, with a functional deltoid muscle, and massive and non-repairable rotator cuff tear within one or more indications and zero contraindications who will receive the Shoulder iD Primary Reversed Glenoid device to replace the shoulder joint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The intended patient population are adult patients who have reached skeletal maturity, with a functional deltoid muscle, and massive and non-repairable rotator cuff tear within one or more indications and zero contraindications with pain disabled by: * Rheumatoid arthritis * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) * Correction of functional deformity * Fractures of the humeral head * Traumatic arthritis * Revision of glenohumeral joint if sufficient native glenoid bone remains
Key inclusion criteria (5 listed)
- 18 years or older at the time of the informed consent or non-opposition (when applicable).
- Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
- Willing and able to comply with the requirements of the study protocol.
- Considered a candidate for shoulder arthroplasty using a study device.
- Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements
Key exclusion criteria (8 listed)
- Patients who are not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times).
- Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred to as a "vulnerable subject" in section 3.44 of the ISO 14155:2020).
- Active local or systemic infection, sepsis, or osteomyelitis
- Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid (reassessed at time of surgery)
- Significant injury to the brachial plexus
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 |
|---|---|---|
| Shoulder iD™ Primary Reversed GlenoidAlso: Patient-Matched Primary Reversed GlenoidDevice implant via reversed total shoulder arthroplasty | Device | Shoulder iD device implant |
Primary outcome
Performance: change in functional ability of the treated shoulder
Time frame: from baseline to 24 months
The average change in functional ability as measured by the American Shoulder and Elbow Surgeons (ASES) score. ASES is an absolute score ranging from 0 to 100 where a higher score indicates better shoulder function.
Safety: Revision rate and device survivorship
Time frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
The cumulative incidence of device revisions and reoperations
5 secondary outcomes
Performance: change in level of pain and ability to carry out normal daily activities of the patient
Time frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Performance: change in patient self-assessment of current status of their treated shoulder
Time frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Performance: change in patient self-rated quality of life
Time frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Performance: change in patient satisfaction with their shoulder
Time frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Safety: Adverse Event rate and assessments
Time frame: from date of treatment until date of study exit (study completion or early termination for any cause), assessed up to 10 years
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 28 Aug 2026.
- 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. This study is not recruiting at the moment.
Rebecca Gibson study director
Stryker Trauma and Extremities
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears and Rheumatoid Arthritis Shoulder, run by Stryker Trauma and Extremities at 5 sites in United States.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance: change in functional ability of the treated shoulder (time frame: from baseline to 24 months). The study lists 2 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 28 Aug 2026.