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.
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
Rheumatoid arthritis
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
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.
Cohort
Prospective
Tornier Perform™ Reversed MonoPost
DeviceThe 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.
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.
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.
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.
Safety: Adverse Event rate and assessments
Cumulative incidence of procedure and/or device related events
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).
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