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| ID | Type | Description | Link |
|---|---|---|---|
| G110207 | Other Identifier | FDA |
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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).
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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive Mini Humeral Stem | Active Comparator | 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. |
|
| Comprehensive Nano Humeral Component | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mini Stem | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Institute for Sports, Knees, and Shoulders | Scottsdale | Arizona | 85255 | United States | ||
| Holy Cross Hospital |
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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Comprehensive Mini Humeral Stem | This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem). |
| FG001 | Comprehensive Nano Humeral Component | This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
258 individual subjects were enrolled in the study. 7 subjects underwent study procedures bilaterally, resulting in 265 shoulders enrolled in the study. Of the 7 bilateral subjects, 1 received two investigational devices, 3 received two control devices, and 3 received one of each device.
| ID | Title | Description |
|---|---|---|
| BG000 | Comprehensive Mini Humeral Stem | This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem). |
| BG001 | Comprehensive Nano Humeral Component |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All subjects with ASES data available at the two year visit were assessed. | Posted | Mean | Standard Deviation | score on a scale | 22+ Months | Shoulders | Shoulders |
|
All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years.
Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Comprehensive Mini Humeral Stem | This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrhythmia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Zimmer Biomet, Inc. | 800-613-6131 | clinicaldirector@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2015 | Nov 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
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|
| Nano | Device | 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. |
|
| 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 |
| Fort Lauderdale |
| Florida |
| 33308 |
| United States |
| Ortho NorthEast | Fort Wayne | Indiana | 46825 | United States |
| Orthopedic Clinic | Shreveport | Louisiana | 71105 | United States |
| Towson Orthopaedic Associates | Towson | Maryland | 21204 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Buffalo | Buffalo | New York | 14214 | United States |
| Joint Implant Surgeons | New Albany | Ohio | 43054 | United States |
| Campbell Clinic Orthopaedics | Germantown | Tennessee | 38138 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Bon Secours St. Francis Medical Center | Midlothian | Virginia | 23114 | United States |
This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
| BG002 | Total | Total of all reporting groups |
| Shoulders |
|
| Years |
| Shoulders |
|
| Sex: Female, Male | Count of Units | Shoulders | Shoulders |
|
| Race/Ethnicity, Customized | Count of Units | Shoulders | Shoulders |
|
| Region of Enrollment | Number | Shoulders | Shoulders |
|
| Procedure on Unilateral/Bilateral Patient | Seven subjects underwent a study procedure on each shoulder, and are classified as bilateral subjects. This measure defines how many study devices were implanted in bilateral subjects and unilateral subjects. | Count of Units | Shoulders | Shoulders |
|
This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).
|
|
| 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. | The total number of cases for each group includes all subjects with two year data, plus all subjects considered failures without two year data. | Posted | Count of Units | Shoulders | 2 years | Shoulders | 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. | All subjects at each time point were evaluated for radiographic success based on these criteria. | Posted | Count of Units | Shoulders | 2 years | Shoulders | 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. | All subjects with an ASES score collected at each specified study time period were assessed. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years | Shoulders | 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. | All subjects with a SANE score collected at each specified study time period were assessed. | Posted | Mean | Standard Deviation | score on a scale | 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years | Shoulders | Shoulders |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years | Shoulders | Shoulders |
|
|
|
| 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. | All subject radiographs at all time points that were submitted to the Independent Radiographic Reviewer were analyzed. | Posted | Count of Units | Shoulders | 2+ years | Shoulders | Shoulders |
|
|
|
| 2 |
| 130 |
| 55 |
| 130 |
| 118 |
| 130 |
| EG001 | Comprehensive Nano Humeral Component | This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component). | 3 | 131 | 41 | 131 | 105 | 131 |
| Death (Non-Shoulder Related) | General disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Pulmonary Embolism | Vascular disorders | Systematic Assessment |
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| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Stroke | Vascular disorders | Systematic Assessment |
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| Other General (Non-Shoulder Related) Complication | General disorders | Systematic Assessment |
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| Dislocation / Subluxation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Implant or Part Failure or Fracture | Surgical and medical procedures | Systematic Assessment |
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| Other Shoulder-Related Complication | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Gastrointestinal Bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
|
| Nerve Injury | Nervous system disorders | Systematic Assessment |
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| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
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| Other General (Non-Shoulder Related) Complication | General disorders | Systematic Assessment |
|
| Delayed Wound Healing | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dislocation / Subluxation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Humeral Fracture or Perforation | Surgical and medical procedures | Systematic Assessment |
|
| Implant or Part Failure or Fracture | Surgical and medical procedures | Systematic Assessment |
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| Inadequate Range of Motion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Instability | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Loosening or Migration of Implants or Parts | Surgical and medical procedures | Systematic Assessment |
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| Nerve Deficit | Nervous system disorders | Systematic Assessment |
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| Unusual Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Wound Problems: Dehiscence, Necrosis, Drainage, Superficial Infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Other Shoulder-Related Complication | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
The Investigator must provide the Sponsor with at least 30 days to review publications for legal and regulatory compliance and will include in publications a statement that the study was supported by the Sponsor. Sponsor confidential information will not be submitted for publication without Sponsor consent. Sponsor may request delay of publication for 60 days to allow for patent application filing.
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