Tornier Perform™ Reversed Monopost Study

NCT07764614 | Not Yet Recruiting FDA Device

• 1 other identifier: UE-10-2025
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  from baseline to 2 years

Secondary Outcomes (5)

• Performance: change in level of pain and ability to carry out normal daily activities of the patient

  from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 2 years

• Performance: change in patient satisfaction with their shoulder

  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

  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

  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

  from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 2 years

Other Outcomes (1)

• Other Endpoint: Radiological Assessment

  Baseline, 6 Month, 1 Year, 2 year

Study Arms (1)

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.

Device: Tornier Perform™ Reversed MonoPost

Interventions

Tornier Perform™ Reversed MonoPost DEVICE

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.

Tornier Perform™ Reversed MonoPost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Officials

• Rebecca Gibson

  Stryker Trauma & Extremities

  STUDY DIRECTOR

Central Study Contacts

Monica Fleeman

CONTACT

251-465-5969; Monica.Fleeman@stryker.com

Rebecca Gibson

CONTACT

Rebecca.Gibson@stryker.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 28, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): August 30, 2031
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share