The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.
The primary objectives of this study are to evaluate the safety and efficacy (defined as follows) of the Sidus Stem-Free Shoulder System in unilateral primary total shoulder arthroplasty. Safety: Will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects (UADEs) in investigational subjects as well as analyzing survivorship using revision or intended revision as an endpoint. Efficacy: Will be determined by comparing the overall pain and functional performance, survivorship and radiographic success of investigational subjects with those subjects who received the control devices.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
95
Stanford University
Redwood City, California, United States
University of California San Francisco - Orthopaedics Institute
San Francisco, California, United States
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire
Pain and function as measured by the American Society of Shoulder and Elbow Surgeons questionnaire. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.
Time frame: Two years
Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment
absence of radiographic evidence of pending failure of the humeral components, assessed at 2 years which may include the following: * implant fracture * progressive implant migration or subsidence ≥ 5 mm
Time frame: Two years
The Number of Device Related Serious Adverse Events.
This outcome will measure the frequency of device related serious adverse events.
Time frame: Two years
Survivorship
The Kaplan-Meier method was used for this study. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 2 years post-operative (whichever came first).
Time frame: Up to Two years
ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire
Pain and function as measured by the American Society of Shoulder and Elbow Surgeons questionnaire. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.
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Norton Orthopaedic & Sports Medicine
Louisville, Kentucky, United States
MedStar Health
Baltimore, Maryland, United States
Washington University
St Louis, Missouri, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Rothman Institute
Philadelphia, Pennsylvania, United States
University of Calgary Sports Medicine Clinic
Calgary, Alberta, Canada
Kingston General Hospital
Kingston, Ontario, Canada
...and 1 more locations
Time frame: 6 weeks, 6 months, and 1 year
SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire.
SF-12 Mental Health and Physical Composite Scores. SF-12 is a validated health survey that uses 12 questions to measure functional health and well being from the patient's point of view. The SF-12 is calculated on a scale of 0 to 100, where a 0 is the worst level of health and 100 is the best level of health. The scores are then normalized with a mean score of 50 and a standard deviation of 10, so that scores greater than 50 represent a health level better than average, and scores less than 50 represent a level lower than average.
Time frame: Pre-Op, 6 weeks, 6 months, 1 year and 2 years