Non-inflammatory Degenerative Joint DiseaseMonarchNCT07764614
Tornier Perform™ Reversed Monopost Study
An observational study of Non-inflammatory Degenerative Joint Disease and Rhematoid Arthritis, run by Stryker Trauma and Extremities at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-inflammatory Degenerative Joint Disease, Rhematoid Arthritis, Correction of Functional Deformity
- What is being tested?
- Tornier Perform™ Reversed MonoPost
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Oct 2026to 30 Aug 2031
- Phase
- Observational
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: 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.
Who may be able to join
- 18 years or older at the time of the informed consent.
- Informed and willing to sign an informed consent form (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC).
- Willing and able to comply with the requirements of the study protocol
- 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:
- Rheumatoid arthritis
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
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- Correction of functional deformity
- Fracture of the Humeral Head
- Traumatic arthritis
- Revision of the devices if sufficient bone stock remains
- Enrollment occurred up to 1 year after date of surgery provided that mandatory data are accessible: including ASES, Constant, and Active ROM.
Who cannot join
- Contraindications or hypersensitivity to the use of the Tornier Perform™ Reversed MonoPost System or their components (e.g., metal sensitivity).
- Participation in the treatment period of another clinical trial during the clinical investigation.
- Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44. Examples include any subject "with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rebecca Gibson contact
United States2 sites, 2 recruiting
- Recruiting
Ohio State University
Columbus, Ohio, 43202
Kate Agan, 6143667598, kate.agan@osumc.edu
Julie Bishop
- Recruiting
Eisenhower Health
Rancho Mirage, California, 92270
Christian Gaxiola, 760-340-3911 ext. 2511, CGaxiola@eisenhowerhealth.org
David Savin
About this study
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.
Read the detailed description
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.
- Conditions
- Non-inflammatory Degenerative Joint Disease, Rhematoid Arthritis, Correction of Functional Deformity, Fracture of the Humeral Head, Traumatic Arthritis, Revision of the Devices if Sufficient Bone Stock Remains
- Being tested
- Tornier Perform™ Reversed MonoPost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tornier Perform™ Reversed MonoPostDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. 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. Receives: Device: Tornier Perform™ Reversed MonoPost |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to 2 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start22 Oct 2026 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-inflammatory Degenerative Joint DiseaseStudies 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
- 150 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 & Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764614
- Sponsor's protocol ID
- UE-10-2025
- Acronym
- Monarch
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No