This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation.
Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.
18 years or older at the time of the informed consent or non-opposition (when applicable).
Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
Willing and able to comply with the requirements of the study protocol.
Considered a candidate for shoulder arthroplasty using a study device.
Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
Active local or systemic infection, sepsis, or osteomyelitis
Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid
Patients intended for the total or partial replacement of the glenohumeral articulation.
Cohort
Prospective
Tornier Perform Humeral - Stem
DeviceThe PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.
Change from Baseline to last follow-up visit in ASES scores
ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function
Change from Baseline to last follow-up visit in Constant Murley scores
Combination of physician-completed and patient-reported portions to assess functional state of shoulder including range of motion; total score reported out of 100 measuring where lower scores indicate less function of the evaluated shoulder
Change from Baseline to last follow-up visit in SANE scores
SANE = Single Assessment Numeric Evaluation; 1 item assessment of shoulder rating 0% to 100%
Change from Baseline to last follow-up visit in Subject Satisfaction scores
Single, subjective question measuring patient satisfaction; assessed by improved, worsened, or no change in satisfaction
Change from Baseline to last follow-up visit in EQ-5D scores
The EuroQol Five Dimensions Questionnaire (EQ-5D) questionnaire is a standardized instrument for use as a measure of quality of life. It is cognitively simple, takes only a few minutes to complete, and provides a simple descriptive profile as well as a single index value for quality of life that can be used in the clinical and economic evaluation of health care. The EQ-5D consists of a descriptive system which comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression), and a visual analog scale which measures the respondent's self-rated health on a 0-100 scale.
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