Joint Disease
Conditions
Keywords
Shoulder, Joint, Osteoarthritis
Brief summary
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
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.
Interventions
DEVICEMini Stem
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.
DEVICENano
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.
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeon's Score (ASES) | 22+ Months | 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. |
| Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation | 2 years | 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. |
| Number of Shoulders With Radiographic Success | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeon's Score (ASES) | Pre-operative, 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years | 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. |
| Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence | 2+ years | 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. |
| Single Assessment Numeric Evaluation (SANE) Score | 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years | 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. |
| Constant Score Adjusted for Age and Gender | Pre-operative, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years | 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. |
Countries
United States
Participant flow
Recruitment details
Due to competitive enrollment, one extra shoulder was randomized and enrolled into the study in the Control group as the site was not aware the study had reached full enrollment. 258 individual subjects were enrolled in the study. 7 subjects underwent study procedures bilaterally, resulting in 265 shoulders enrolled in the study.
Pre-assignment details
Subjects were randomized 1:1 to either the Comprehensive Shoulder System with Nano Humeral Component (Investigational) or the Comprehensive Shoulder System with Mini Humeral Stem (Control). Treatment assignments occurred intraoperatively and subjects remained blinded until completion of two-year follow-up for all subjects.
Participants by arm
| Arm | Count |
|---|---|
| Comprehensive Mini Humeral Stem This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem). | 130 |
| Comprehensive Mini Humeral Stem This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem). | 133 |
| Comprehensive Nano Humeral Component This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component). | 131 |
| Comprehensive Nano Humeral Component This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component). | 132 |
| Total | 526 |
Baseline characteristics
| Characteristic | Comprehensive Nano Humeral Component | Total | Comprehensive Mini Humeral Stem |
|---|---|---|---|
| Age, Continuous | 63.1 Years STANDARD_DEVIATION 9 | 62.6 Years STANDARD_DEVIATION 9.3 | 62.1 Years STANDARD_DEVIATION 9.6 |
| Procedure on Unilateral/Bilateral Patient Bilateral | 5 Shoulders | 14 Shoulders | 9 Shoulders |
| Procedure on Unilateral/Bilateral Patient Unilateral | 127 Shoulders | 251 Shoulders | 124 Shoulders |
| Race/Ethnicity, Customized African American | 4 Shoulders | 10 Shoulders | 6 Shoulders |
| Race/Ethnicity, Customized Asian | 1 Shoulders | 1 Shoulders | 0 Shoulders |
| Race/Ethnicity, Customized Caucasian | 126 Shoulders | 251 Shoulders | 125 Shoulders |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Shoulders | 3 Shoulders | 2 Shoulders |
| Region of Enrollment United States | 132 Shoulders | 265 Shoulders | 133 Shoulders |
| Sex: Female, Male Female | 43 Shoulders | 89 Shoulders | 46 Shoulders |
| Sex: Female, Male Male | 89 Shoulders | 176 Shoulders | 87 Shoulders |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 130 | 3 / 131 |
| other Total, other adverse events | 118 / 130 | 105 / 131 |
| serious Total, serious adverse events | 55 / 130 | 41 / 131 |
Outcome results
Primary
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
Population: All subjects with ASES data available at the two year visit were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comprehensive Mini Humeral Stem | American Shoulder and Elbow Surgeon's Score (ASES) | 92.20 score on a scale | Standard Deviation 13.51 |
| Comprehensive Nano Humeral Component | American Shoulder and Elbow Surgeon's Score (ASES) | 92.47 score on a scale | Standard Deviation 14.94 |
Primary
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
Population: The total number of cases for each group includes all subjects with two year data, plus all subjects considered failures without two year data.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Comprehensive Mini Humeral Stem | Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation | Success Shoulders | 114 Shoulders |
| Comprehensive Mini Humeral Stem | Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation | Failure Shoulders | 9 Shoulders |
| Comprehensive Nano Humeral Component | Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation | Success Shoulders | 107 Shoulders |
| Comprehensive Nano Humeral Component | Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation | Failure Shoulders | 9 Shoulders |
Primary
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
Population: All subjects at each time point were evaluated for radiographic success based on these criteria.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Comprehensive Mini Humeral Stem | Number of Shoulders With Radiographic Success | Success Shoulders | 133 Shoulders |
| Comprehensive Mini Humeral Stem | Number of Shoulders With Radiographic Success | Failure Shoulders | 0 Shoulders |
| Comprehensive Nano Humeral Component | Number of Shoulders With Radiographic Success | Success Shoulders | 132 Shoulders |
| Comprehensive Nano Humeral Component | Number of Shoulders With Radiographic Success | Failure Shoulders | 0 Shoulders |
Secondary
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: Pre-operative, 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years
Population: All subjects with an ASES score collected at each specified study time period were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Mini Humeral Stem | American Shoulder and Elbow Surgeon's Score (ASES) | Pre-operative | 25.8 score on a scale | Standard Deviation 9.6 |
| Comprehensive Mini Humeral Stem | American Shoulder and Elbow Surgeon's Score (ASES) | 3 Months | 80.2 score on a scale | Standard Deviation 16.4 |
| Comprehensive Mini Humeral Stem | American Shoulder and Elbow Surgeon's Score (ASES) | 4 Years | 95.1 score on a scale | Standard Deviation 6.4 |
| Comprehensive Mini Humeral Stem | American Shoulder and Elbow Surgeon's Score (ASES) | 1 Year | 91.2 score on a scale | Standard Deviation 12.8 |
| Comprehensive Mini Humeral Stem | American Shoulder and Elbow Surgeon's Score (ASES) | 6 Weeks | 60.1 score on a scale | Standard Deviation 18.3 |
| Comprehensive Mini Humeral Stem | American Shoulder and Elbow Surgeon's Score (ASES) | 2 Years | 92.2 score on a scale | Standard Deviation 13.5 |
| Comprehensive Mini Humeral Stem | American Shoulder and Elbow Surgeon's Score (ASES) | 3 Years | 95.0 score on a scale | Standard Deviation 9.8 |
| Comprehensive Nano Humeral Component | American Shoulder and Elbow Surgeon's Score (ASES) | 2 Years | 92.5 score on a scale | Standard Deviation 14.9 |
| Comprehensive Nano Humeral Component | American Shoulder and Elbow Surgeon's Score (ASES) | 3 Years | 90.0 score on a scale | Standard Deviation 17.8 |
| Comprehensive Nano Humeral Component | American Shoulder and Elbow Surgeon's Score (ASES) | 4 Years | 94.3 score on a scale | Standard Deviation 11.3 |
| Comprehensive Nano Humeral Component | American Shoulder and Elbow Surgeon's Score (ASES) | Pre-operative | 25.1 score on a scale | Standard Deviation 10.7 |
| Comprehensive Nano Humeral Component | American Shoulder and Elbow Surgeon's Score (ASES) | 6 Weeks | 61.5 score on a scale | Standard Deviation 17.4 |
| Comprehensive Nano Humeral Component | American Shoulder and Elbow Surgeon's Score (ASES) | 3 Months | 80.5 score on a scale | Standard Deviation 15.3 |
| Comprehensive Nano Humeral Component | American Shoulder and Elbow Surgeon's Score (ASES) | 1 Year | 92.8 score on a scale | Standard Deviation 12.2 |
Secondary
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
Population: All subjects with a Constant score collected at each specified study time period were assessed. The score was not collected at 6 weeks to protect the subscapularis repair.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Mini Humeral Stem | Constant Score Adjusted for Age and Gender | Pre-operative | 47.2 score on a scale | Standard Deviation 17.1 |
| Comprehensive Mini Humeral Stem | Constant Score Adjusted for Age and Gender | 3 Months | 82.6 score on a scale | Standard Deviation 18.8 |
| Comprehensive Mini Humeral Stem | Constant Score Adjusted for Age and Gender | 1 Year | 97.9 score on a scale | Standard Deviation 16.8 |
| Comprehensive Mini Humeral Stem | Constant Score Adjusted for Age and Gender | 2 Years | 100.2 score on a scale | Standard Deviation 15 |
| Comprehensive Mini Humeral Stem | Constant Score Adjusted for Age and Gender | 3 Years | 100.2 score on a scale | Standard Deviation 14.4 |
| Comprehensive Mini Humeral Stem | Constant Score Adjusted for Age and Gender | 4 Years | 98.0 score on a scale | Standard Deviation 12 |
| Comprehensive Nano Humeral Component | Constant Score Adjusted for Age and Gender | 3 Years | 99.2 score on a scale | Standard Deviation 17.3 |
| Comprehensive Nano Humeral Component | Constant Score Adjusted for Age and Gender | Pre-operative | 46.3 score on a scale | Standard Deviation 17.1 |
| Comprehensive Nano Humeral Component | Constant Score Adjusted for Age and Gender | 2 Years | 101.5 score on a scale | Standard Deviation 16.7 |
| Comprehensive Nano Humeral Component | Constant Score Adjusted for Age and Gender | 3 Months | 83.1 score on a scale | Standard Deviation 19.1 |
| Comprehensive Nano Humeral Component | Constant Score Adjusted for Age and Gender | 4 Years | 103.5 score on a scale | Standard Deviation 15.6 |
| Comprehensive Nano Humeral Component | Constant Score Adjusted for Age and Gender | 1 Year | 99.8 score on a scale | Standard Deviation 14.9 |
Secondary
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
Population: All subject radiographs at all time points that were submitted to the Independent Radiographic Reviewer were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Comprehensive Mini Humeral Stem | Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence | Success Shoulders | 133 Shoulders |
| Comprehensive Mini Humeral Stem | Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence | Failure Shoulders | 0 Shoulders |
| Comprehensive Nano Humeral Component | Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence | Success Shoulders | 132 Shoulders |
| Comprehensive Nano Humeral Component | Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence | Failure Shoulders | 0 Shoulders |
Secondary
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
Population: All subjects with a SANE score collected at each specified study time period were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Mini Humeral Stem | Single Assessment Numeric Evaluation (SANE) Score | 6 Weeks | 55.7 score on a scale | Standard Deviation 24.2 |
| Comprehensive Mini Humeral Stem | Single Assessment Numeric Evaluation (SANE) Score | 3 Months | 80.4 score on a scale | Standard Deviation 14.9 |
| Comprehensive Mini Humeral Stem | Single Assessment Numeric Evaluation (SANE) Score | 1 Year | 90.4 score on a scale | Standard Deviation 12.2 |
| Comprehensive Mini Humeral Stem | Single Assessment Numeric Evaluation (SANE) Score | 2 Years | 92.3 score on a scale | Standard Deviation 11.9 |
| Comprehensive Mini Humeral Stem | Single Assessment Numeric Evaluation (SANE) Score | 3 Years | 94.7 score on a scale | Standard Deviation 6.9 |
| Comprehensive Mini Humeral Stem | Single Assessment Numeric Evaluation (SANE) Score | 4 Years | 93.4 score on a scale | Standard Deviation 7 |
| Comprehensive Nano Humeral Component | Single Assessment Numeric Evaluation (SANE) Score | 3 Years | 91.5 score on a scale | Standard Deviation 15.5 |
| Comprehensive Nano Humeral Component | Single Assessment Numeric Evaluation (SANE) Score | 6 Weeks | 53.7 score on a scale | Standard Deviation 23.9 |
| Comprehensive Nano Humeral Component | Single Assessment Numeric Evaluation (SANE) Score | 2 Years | 92.3 score on a scale | Standard Deviation 14.5 |
| Comprehensive Nano Humeral Component | Single Assessment Numeric Evaluation (SANE) Score | 3 Months | 80.7 score on a scale | Standard Deviation 16.1 |
| Comprehensive Nano Humeral Component | Single Assessment Numeric Evaluation (SANE) Score | 4 Years | 93.0 score on a scale | Standard Deviation 12.9 |
| Comprehensive Nano Humeral Component | Single Assessment Numeric Evaluation (SANE) Score | 1 Year | 92.2 score on a scale | Standard Deviation 9.3 |