Comprehensive Shoulder System Nano IDE

Study Overview
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Brief Summary
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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).

Detailed Description
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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): American Shoulder and Elbow Surgeons (ASES) Score Single Assessment Numeric Evaluation (SANE) Constant Score Radiographic assessment of osteolysis, radiolucencies, migration, and subsidence Comparison of overall adverse event rates including rates of removal/revision and other serious adverse events.

Official Title
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A Study of the Comprehensive Shoulder System With Nano Humeral Component in Total Shoulder Arthroplasty

Conditions
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Joint Disease

Intervention / Treatment
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* Device: Mini Stem
* Device: Nano


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients for whom the surgeon has confirmed intraoperatively, has no cyst > 1cm and not more than one cyst at the implantation site Patients with non-inflammatory degenerative joint disease including osteoarthritis. Patients where the device will be used in the correction of a functional deformity (deformities preventing congruent articulation of the glenohumeral joint) Patients with pain and/or loss of function in the shoulder for whom other treatment modalities have been unsuccessful. Patients requiring unilateral or staged bilateral shoulder arthroplasty Patient must be anatomically and structurally suited to receive the implants (humeral neck must be of sufficient diameter to implant at least the smallest nano humeral component and the humeral neck is intact). Patients who are 21-90 years of age at the time of surgery and have reached skeletal maturity. Patients with an ASES score ≤ 40. Exclusion Criteria: Patients diagnosed with avascular necrosis or post-traumatic arthritis of the humeral head Patients found at the time of intraoperative examination to have a single cyst >1 cm in size or multiple cysts at the implantation site Patient presents with shoulder joint infection, sepsis, osteomyelitis or distant foci of infections which may spread to the implant site. Patients with cuff tear arthropathy. Patients who have undergone a Hemi-, Total, or Reverse Total Shoulder arthroplasty in the affected shoulder. Patient presents with a malunion or non-union of the tuberosities of the proximal humerus. Patients with osteoporosis, osteomalacia, rheumatoid arthritis, metabolic disorders of bone, muscle or connective tissue, gross deformity or any other condition of the proximal humerus (defined as severe destruction or deformity of the proximal humerus that precludes placement of the device) that in the Investigator's medical judgment could compromise implant fixation or bone healing. Rapid bone destruction, marked bone loss or bone resorption apparent on roentgenogram. Patients with neurologic or other disorders that would either affect the stability of the shoulder prosthesis, i.e., Charcot's joint, uncontrolled seizures, etc., or would affect their capability or willingness to return to the clinic for assessments and/or follow directions. Bone cancer, either primary or secondary, that affects the shoulder. Patients presenting with symptoms of chronic steroid use. (oral steroids for a chronic condition for 12 months prior to and including the date of surgery) Patients with a life expectancy of less than three years. Patients diagnosed with severe shoulder instability Patients diagnosed with subscapularis incompetence Patients diagnosed with any condition that may limit their ability to complete the consent form or would affect their capability or willingness to return to the clinic for assessments and/or follow directions (i.e. mental illness) Patients with known metal allergy Patients who refuse to sign the Institutional Review Board (IRB) approved consent form Patients who are found intraoperatively to require a specific treatment and are unable to be randomized.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comprehensive Mini Humeral Stem<br>The Comprehensive® Shoulder System with mini stem component, which will be the control device for this clinical investigation and was 510(k) cleared under K060692 on May 30, 2006. 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. | Device: Mini Stem<br>* 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.<br>|
| Experimental: Comprehensive Nano Humeral Component<br>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. | Device: Nano<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 2+ years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder, Joint, Osteoarthritis