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.
Study Type
OBSERVATIONAL
Enrollment
150
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
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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