The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).
The purpose of this clinical investigation is to establish the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty. Safety and efficacy of the device will be measured by collection and analysis of the following data at the two-year or greater time point (22 months post-operative or longer): 1. American Shoulder and Elbow Surgeons (ASES) Score 2. Single Assessment Numeric Evaluation (SANE) 3. Constant Score 4. Radiographic assessment of osteolysis, radiolucencies, migration, and subsidence 5. Comparison of overall adverse event rates including rates of removal/revision and other serious adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
258
The humeral stem component is manufactured from Ti6Al4V alloy. The taper has a machine finish and accepts the taper adaptor of the humeral head component. The proximal region of the bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy, while the distal portion is polished. Seventeen stem diameters are available - 4 mm to 20 mm, in 1-mm increments.
The stemless humeral component is manufactured from Ti6Al4V alloy. It consists of a central tapered region and six outer wings. The taper has a machine finish and accepts the taper adaptor of the humeral head component. A small groove is included just below the taper to accept an inserter/impactor. The bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy for cementless fixation in the proximal humerus. Six sizes are available - 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, and 40 mm.
Arizona Institute for Sports, Knees, and Shoulders
Scottsdale, Arizona, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Ortho NorthEast
Fort Wayne, Indiana, United States
American Shoulder and Elbow Surgeon's Score (ASES)
The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.
Time frame: 22+ Months
Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation
This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "No unanticipated device-related adverse event, and no fracture, perforation of the bone or joint dislocation, and no fracture, perforation or dissociation of the device, and no revision or removal of any component." All subject records were evaluated for each of the disqualifying factors, and all subjects that failed at least one of the endpoint measures were identified. The success rate is defined as the number of subjects at two years not meeting any of the disqualifying factors compared to the total number of cases present at two years plus all subjects considered failures without two year data.
Time frame: 2 years
Number of Shoulders With Radiographic Success
This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "Subsidence of the humeral component \<5 mm, and migration of the humeral component \<5 mm, and no progressive lucency around the humeral component \>2 mm in two or more contiguous zones, and migration of the glenoid component \<5 mm, and no progressive lucency \>2 mm around the entire glenoid component." All subject records were evaluated by an Independent Radiographic Reviewer (IRR) at each time point for radiographic success based on these criteria.
Time frame: 2 years
American Shoulder and Elbow Surgeon's Score (ASES)
The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Orthopedic Clinic
Shreveport, Louisiana, United States
Towson Orthopaedic Associates
Towson, Maryland, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Buffalo
Buffalo, New York, United States
Joint Implant Surgeons
New Albany, Ohio, United States
Campbell Clinic Orthopaedics
Germantown, Tennessee, United States
...and 2 more locations
Time frame: Pre-operative, 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years
Single Assessment Numeric Evaluation (SANE) Score
The Single Assessment Numeric Evaluation (SANE) Score is a tool used to assess the subject's perception of their affected joint. Participants are requested to rate their shoulder function on a scale of 0 to 100, with 0 as the worst option and 100 being normal shoulder function.
Time frame: 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years
Constant Score Adjusted for Age and Gender
The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function. The age- and gender-adjusted Constant score normalizes the raw Constant score based on the subject's age and gender. The worst score on the adjusted scale is still 0, but the greatest scores can exceed 100 based on the calculations used for normalization. The scale used in this study was described by Katolik et al.
Time frame: Pre-operative, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years
Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence
All radiographs collected at all follow-up time points were analyzed by the Independent Radiographic reviewer. Subjects were assessed for the presence of radiolucencies considered to be failures of the radiographic co-primary endpoint (No progressive lucency around the humeral component \>2 mm in two or more contiguous zones OR no progressive lucency \>2 mm around the entire glenoid component) and for the presence of component subsidence. Subjects with the absence of failing radiolucencies and subsidence were considered successes.
Time frame: 2+ years