An observational study in Non-inflammatory Degenerative Joint Disease, Rhematoid Arthritis and Correction of Functional Deformity, sponsored by Stryker Trauma and Extremities. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Stryker Trauma and Extremities (part of Stryker) · Observational
This study is a Multi-center, Prospective Follow-up, Non-significant risk, Post-Market Clinical Follow-Up (PMCF) study to Evaluate the Safety and Effectiveness of the Tornier Perform™ Reversed MonoPost System.
It is anticipated that a total of 150 subjects will be enrolled at up to ten sites over a one year enrollment period. The study has been designed to follow the surgeon's standard of care for subjects treated with shoulder arthroplasty with the device including imaging (x-rays and or CT scans).
The primary endpoint of this study is to demonstrate pain relief and improved subjects' shoulder functionality by achieving a mean target of 25-points Total ASES Score improvement, for each type of glenoid (two sub cohorts: Standard with/without BIO-RSA and Augmented baseplate) at 2 years follow-up compared to baseline. Secondary objectives are to collect postoperative data on the related clinical complications and functional outcomes of the device to demonstrate the safety and performance of these implants in a real-world setting.
Stryker Trauma and Extremities is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Approximately 150 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for an shoulder arthroplasty will be evaluated for clinical investigation participation based on the eligibility criteria. No specific methods (such as randomization, blinding or stratification) for assigning participants are used in this protocol. Consecutive participants at each site meeting all of the eligibility criteria will be considered for enrollment in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Considered a candidate or having received shoulder arthroplasty with the device, having a functional deltoid muscle and with massive and non-repairable rotator cuff tear with pain disabled by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Commercially available Tornier Perform™ Reversed MonoPost Glenoid is intended to replace the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis. The Tornier Perform™ Reversed MonoPost Glenoid includes new range of glenoid baseplates for Bony Increased Offset -Reversed Shoulder Arthroplasty (BIO-RSA) and a new range of glenoid baseplates with metallic augmentation to accommodate specific patterns of glenoid wear in patients.
Device: Tornier Perform™ Reversed MonoPost
The Commercially available Tornier Perform™ Reversed MonoPost Glenoid is intended to replace the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis.
Performance: American Shoulder and Elbow Surgeons (ASES) score- 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.
Time frame: from baseline to 2 years
Performance: Constant-Murley Shoulder score- 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, 6mths, 1 year, 2 years 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 range of movement and shoulder strength. A score of 100 is a healthy shoulder.
Time frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 2 years
Performance: Subject Satisfaction- change in patient satisfaction with their shoulder
Satisfaction rating collected from patients at baseline, 6 months, and annually. Rating options are: Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied.
Time frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 2 years
Performance: Range of Motion
Active range of motion collected at baseline, 6mths, 1 year and 2 years and any other standard collection timepoint. To evaluate shoulder function, measuring internal and external rotation, forward flexion, extension, and abduction.
Time frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 2 years
Safety: Adverse Event rate and assessments
Cumulative incidence of procedure and/or device related events
Time frame: from date of treatment until date of study exit (study completion or early termination for any cause), assessed up to 2 years
Safety: Revision rate and device survivorship
The cumulative incidence of device revisions and reoperations
Time frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 2 years
Other Endpoint: Radiological Assessment
X-rays will be analyzed, when sufficient information is available, for component loosening and/or subsidence, any osteolysis, cyst formation, implants breakage, dissociation or any relevant radiological observation (migration, radiolucency, bone wear).
Time frame: Baseline, 6 Month, 1 Year, 2 year
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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