Titan Modular Total Shoulder System
Devicetotal shoulder arthroplasty using the Titan Modular Total Shoulder System
NCT Number: NCT03956316
The goals of total, reverse total and hemi shoulder arthroplasty are the same, to alleviate the patient's pain and obtain a full functional recovery. This outcome depends on the surgeon's ability to reproduce normal glenohumeral anatomy including bone morphology, capsular tension and rotator cuff function. Shoulder arthroplasty has become a safe and effective treatment for various diseases of the shoulder. This study goal is to document and report the short-term functional, radiographic, and quality of life outcomes of total shoulder arthroplasty (TSA) using the titan modular shoulder system.
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Inclusion criteria
Exclusion criteria
total shoulder arthroplasty using the Titan Modular Total Shoulder System
Time frame: two year post op
i. The ASES consists of two dimensions: pain and function (worth 50 points each).
a. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. Patient questions focus on: joint pain, instability and activities of daily living. Physician questions focus on: range of motion, strength, signs and instability
Time frame: two year post op
a. The EQ5D-5L scale evaluates general health status. The EQ-5D-5L has two sections; the first section measures health status using a descriptive system (index of 5 scores) and the second section measures health status on a Visual Analog Scale.
i. The EQ-5D-5L VAS outcome is measured on a 0 - 100 point scale. Optimal health status is indicated with a score of 100.
ii. The EQ-5D-5L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is evaluated with a score of 1-5, higher scores indicate worse outcomes.
Time frame: two year post op
Time frame: two year post op
Time frame: two year post op
Time frame: two year post op
i. WOOS is composed of 19 items scored on 100-point VAS scales. The 19 items represent four domains (6 questions for pain and physical symptoms, 5 questions for sport/recreation/work function, 5 questions for lifestyle function and 3 questions for emotional function).
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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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