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NCT Number: NCT07764614

Tornier Perform™ Reversed Monopost 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.

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Key information

Conditions

Non-inflammatory Degenerative Joint Disease Correction of Functional Deformity Fracture of the Humeral Head Revision of the Devices if Sufficient Bone Stock Remains Rhematoid Arthritis Traumatic Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Performance: change in functional ability of the treated shoulder

    Time frame: from baseline to 2 years

    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.

Secondary outcomes

  1. 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 2 years

    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.

  2. 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 2 years

    Satisfaction rating collected from patients at baseline, 6 months, and annually. Rating options are: Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied.

  3. Performance: Range of Motion

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

    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.

  4. 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 2 years

    Cumulative incidence of procedure and/or device related events

  5. 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 2 years

    The cumulative incidence of device revisions and reoperations

Other outcomes

  1. Other Endpoint: Radiological Assessment

    Time frame: Baseline, 6 Month, 1 Year, 2 year

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Monica Fleeman

CONTACT

[email protected]

251-465-5969

Rebecca Gibson

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Stryker Trauma and Extremities

Industry

Registry information

Acronym: Monarch

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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