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The purpose of this study is to demonstrate safety and effectiveness of the Aequalis Pyrocarbon Humeral Head in hemiarthroplasty at 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemi Shoulder Arthroplasty | Experimental | Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aequalis Pyrocarbon Humeral Head | Device | Hemi Shoulder Arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Patient Success at 24 Months. | A subject is a success at 24 months if:
| 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Constant Score | Constant Score: In this score, 35 points are allocated for subjective assessments of pain and activities of daily living and 65 points are available for objective measures of range of movement and shoulder strength. A young healthy patient can therefore have a maximum score of 100 points. The minimum score is 0 points. The range of the score is 0-100 for both the Constant Score and the adjusted Constant score. A higher value represents a better outcome. Average of 2 pain scores (15 points max) Sum of 4 activities of daily living questions (20 points max) Sum of 4 ROM measure (40 points max) Power score (25 points max) Change in Constant Score and Adjusted Constant Score at 24 months compared to baseline is presented along with absolute values. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
Individual participant data will not be available to other researchers. Only aggregate data will be shared with the researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tornier Pyrocarbon Humeral Head | The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex stem. The Aequalis Pyrocarbon Humeral Head shoulder prosthesis, combined with the Aequalis Ascend Flex stem, is to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain. This is a hemiarthroplasty procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tornier Pyrocarbon Humeral Head | The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex stem. The Aequalis Pyrocarbon Humeral Head shoulder prosthesis, combined with the Aequalis Ascend Flex stem, is to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain. This is a hemiarthroplasty procedure. |
| 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 | Rate of Patient Success at 24 Months. | A subject is a success at 24 months if:
| This number of participants is 146 as 10 patients were lost to follow-up (were not seen at 24 months) and one patient did not have a baseline Constant Score. | Posted | Count of Participants | Participants | 24 Months |
|
Adverse events were collected from subject enrollment to the end of participation in the study which included two years of follow-up.
An Adverse Event is any unfavorable or unintended sign, symptom, condition or disease in a study subject, where the experience occurs during the course of the study; regardless of its relationship to the test product or surgical procedure. For the purpose of this study, investigators are required to report all adverse events.
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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 | Tornier Pyrocarbon Humeral Head | The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex stem. The Aequalis Pyrocarbon Humeral Head shoulder prosthesis, combined with the Aequalis Ascend Flex stem, is to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain. This is a hemiarthroplasty procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ARTHROFIBROSIS, TREATED SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain, Treated Shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matt Venegoni | Stryker | 612-297-0939 | matthew.venegoni@stryker.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2017 | Oct 5, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 7, 2019 | Oct 5, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 24 Months |
| American Shoulder and Elbow Surgeons (ASES) Score | American Shoulder and Elbow Surgeons Standardized Shoulder Assessment. The original ASES consists of 2 portions, a medical professional assessment section and a patient self-report section. The patient self-report section utilized in this study is a condition specific scale intended to measure functional limitations and pain of the shoulder. The assessment takes approximately 5 minutes to complete and consists of 2 dimensions: pain and activities of daily living. The pain score is calculated from the single pain question and the function score from the sum of the 10 questions addressing function. The pain score and function composite score are weighted equally (50 points each) and combined for a total score out of a possible 100 points. The minimum score is 0 and the maximum score is 100. A higher value represents a better outcome. Change in American Shoulder and Elbow Surgeons (ASES) Score at 24 months compared to baseline are presented. | 24 Months |
| Single Assessment Numeric Evaluation (SANE) | The SANE rating is determined by the subject's written response to the following question "How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?" Change in Single Assessment Numeric Evaluation (SANE) at 24 months compared to baseline | 24 Months |
| EQ-5D Index | EQ-5D: a standardized instrument for use as a measure of health outcome. It is cognitively simple, takes only a few minutes to complete, and provides a simple descriptive profile as well as a single index value for health status. Scale 0 to 1; 1 (representing full health) to 0 (representing dead). Change in EQ-5D score at 24 months compared to baseline | 24 Months |
| Pain Measured by a VIsual Analog Scale (VAS) | Pain is measured by a visual analog scale (from 0-10). The subject responds to the question: How bad is your pain TODAY. 0 is no pain; 10 is pain as bad as it can be. Change in pain measured by a visual analog scale (VAS) at 24 months compared to baseline | 24 Months |
| Range of Motion (ROM) | Range of Motion (ROM) is a movement test conducted on a joint to diagnose level of pain and function. The shoulder joint has a greater Range of Motion than all other joints in the body. In this study, ROM was measured using a goniometer for forward flexion in relation to the thorax, abduction, and external rotation (arm at side and arm abducted to 90°). Change in Range of Motion (ROM) at 24 months compared to baseline.
| 24 Months |
| Strength | The subject's strength will be assessed using a fixed force gauge. The fixed force gauge is held in place by the examiner and the subject pulls upward with maximum effort for approximately five seconds. The test can be completed up to three times and the maximum score is used, however all three pulls will be recorded. The test is done only on the affected arm. The result of this test contributes to the Constant score calculation. Change in Strength testing at 24 months compared to baseline | 24 Months |
| Number of Participants With Device-related Serious Adverse Events | Adverse Events data will be collected and summarized at 24 months. | 24 Months |
| Revision Rate | A revision is a procedure that adjusts or in any way modifies or removes any component of the original implant configuration, with or without replacement of a component, after the initial surgery. A revision may also include adjusting the position of the original configuration. An explant is a revision that includes permanent removal of any system component. If a subject has a revision that includes an addition of a glenoid component (revision to TSA) the Pyrocarbon humeral head must be permanently explanted. The Revision Rate will be calculated and summarized at 24 months. | 24 Months |
| Level of Satisfaction With the Shoulder | The level of satisfaction with the shoulder will be summarized at 24 months. | 24 Months |
| X-Ray Data | The follow data will be summarized at 24 Months: glenohumeral joint space width, glenoid osteophytes, glenoid morphology, humeral component radiolucency, osteolysis, migration, subsidence, subluxation, acromial humeral distance, anatomic fracture, and additional observations | 24 Months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Constant Score | Constant Score: In this score, 35 points are allocated for subjective assessments of pain and activities of daily living and 65 points are available for objective measures of range of movement and shoulder strength. A young healthy patient can therefore have a maximum score of 100 points. The minimum score is 0 points. A higher value represents a better outcome.
| Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Constant Score | Constant Score: In this score, 35 points are allocated for subjective assessments of pain and activities of daily living and 65 points are available for objective measures of range of movement and shoulder strength. A young healthy patient can therefore have a maximum score of 100 points. The minimum score is 0 points. The range of the score is 0-100 for both the Constant Score and the adjusted Constant score. A higher value represents a better outcome. Average of 2 pain scores (15 points max) Sum of 4 activities of daily living questions (20 points max) Sum of 4 ROM measure (40 points max) Power score (25 points max) Change in Constant Score and Adjusted Constant Score at 24 months compared to baseline is presented along with absolute values. | 143 were analyzed as 10 patients were lost to follow-up, one patient did not have a baseline Constant Score, and three patients were revised prior to a 24-month visit. | Posted | Mean | Standard Deviation | units on a scale | 24 Months |
|
|
|
| Secondary | American Shoulder and Elbow Surgeons (ASES) Score | American Shoulder and Elbow Surgeons Standardized Shoulder Assessment. The original ASES consists of 2 portions, a medical professional assessment section and a patient self-report section. The patient self-report section utilized in this study is a condition specific scale intended to measure functional limitations and pain of the shoulder. The assessment takes approximately 5 minutes to complete and consists of 2 dimensions: pain and activities of daily living. The pain score is calculated from the single pain question and the function score from the sum of the 10 questions addressing function. The pain score and function composite score are weighted equally (50 points each) and combined for a total score out of a possible 100 points. The minimum score is 0 and the maximum score is 100. A higher value represents a better outcome. Change in American Shoulder and Elbow Surgeons (ASES) Score at 24 months compared to baseline are presented. | ASES Increase reported. 144 were analyzed as 10 patients were lost to follow-up (no 24-month visit) and three patients were revised prior to the 24-month visit. | Posted | Mean | Standard Deviation | units on a scale | 24 Months |
|
|
|
| Secondary | Single Assessment Numeric Evaluation (SANE) | The SANE rating is determined by the subject's written response to the following question "How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?" Change in Single Assessment Numeric Evaluation (SANE) at 24 months compared to baseline | SANE score increase reported. 144 were analyzed as 10 patients were lost to follow-up and three patients were revised prior to 24-month visit. | Posted | Mean | Standard Deviation | score on a scale | 24 Months |
|
|
|
| Secondary | EQ-5D Index | EQ-5D: a standardized instrument for use as a measure of health outcome. It is cognitively simple, takes only a few minutes to complete, and provides a simple descriptive profile as well as a single index value for health status. Scale 0 to 1; 1 (representing full health) to 0 (representing dead). Change in EQ-5D score at 24 months compared to baseline | EQ-5D score increase reported. 144 were analyzed as 10 patients were lost to follow-up and three were revised prior to a 24-month visit. | Posted | Mean | Standard Deviation | units on a scale | 24 Months |
|
|
|
| Secondary | Pain Measured by a VIsual Analog Scale (VAS) | Pain is measured by a visual analog scale (from 0-10). The subject responds to the question: How bad is your pain TODAY. 0 is no pain; 10 is pain as bad as it can be. Change in pain measured by a visual analog scale (VAS) at 24 months compared to baseline | Change in Pain by VAS reported (decrease in pain). 144 were analyzed as 10 patients were lost to follow-up and three patients were revised prior to a 24-month visit. | Posted | Mean | Standard Deviation | score on a scale | 24 Months |
|
|
|
| Secondary | Range of Motion (ROM) | Range of Motion (ROM) is a movement test conducted on a joint to diagnose level of pain and function. The shoulder joint has a greater Range of Motion than all other joints in the body. In this study, ROM was measured using a goniometer for forward flexion in relation to the thorax, abduction, and external rotation (arm at side and arm abducted to 90°). Change in Range of Motion (ROM) at 24 months compared to baseline.
| 144 patients were analyzed as 10 patients were lost to follow-up and three patients were revised prior to a 24-month visit. | Posted | Mean | Standard Deviation | Degrees | 24 Months |
|
|
|
| Secondary | Strength | The subject's strength will be assessed using a fixed force gauge. The fixed force gauge is held in place by the examiner and the subject pulls upward with maximum effort for approximately five seconds. The test can be completed up to three times and the maximum score is used, however all three pulls will be recorded. The test is done only on the affected arm. The result of this test contributes to the Constant score calculation. Change in Strength testing at 24 months compared to baseline | Increase in Strength reported. 144 were analyzed as 10 patients were lost to lost to follow-up and three patients were revised prior to a 24-month visit. | Posted | Mean | Standard Deviation | Pounds | 24 Months |
|
|
|
| Secondary | Number of Participants With Device-related Serious Adverse Events | Adverse Events data will be collected and summarized at 24 months. | Device-related Serious Adverse Events | Posted | Count of Participants | Participants | 24 Months |
|
|
|
| Secondary | Revision Rate | A revision is a procedure that adjusts or in any way modifies or removes any component of the original implant configuration, with or without replacement of a component, after the initial surgery. A revision may also include adjusting the position of the original configuration. An explant is a revision that includes permanent removal of any system component. If a subject has a revision that includes an addition of a glenoid component (revision to TSA) the Pyrocarbon humeral head must be permanently explanted. The Revision Rate will be calculated and summarized at 24 months. | 147 were analyzed as 10 patients were lost to follow-up. | Posted | Count of Participants | Participants | 24 Months |
|
|
|
| Secondary | Level of Satisfaction With the Shoulder | The level of satisfaction with the shoulder will be summarized at 24 months. | Posted | Count of Participants | Participants | 24 Months |
|
|
|
| Secondary | X-Ray Data | The follow data will be summarized at 24 Months: glenohumeral joint space width, glenoid osteophytes, glenoid morphology, humeral component radiolucency, osteolysis, migration, subsidence, subluxation, acromial humeral distance, anatomic fracture, and additional observations | 144 subjects were analyzed as 10 subjects were lost to follow-up and three patients were revised prior to a 24-month visit. | Posted | Count of Participants | Participants | 24 Months |
|
|
|
| 0 |
| 157 |
| 5 |
| 157 |
| 45 |
| 157 |
| UNEXPECTED POSITIVE CULTURE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ROTATOR CUFF TEAR, TREATED SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| PAIN, TREATED SHOULDER; INFECTION, TREATED SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain, Treated Shoulder; MVC; Cervical Spondylosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain, Contralateral Shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| OA, in other non-study shoulder joints | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
If a manuscript for the multi-center Publication has not been submitted within twelve (12) months of the conclusion (as defined in the Protocol), abandonment or termination of the Study, then the Researchers may Publish a subset of multi-center results of the Study. Sponsor personnel shall be acknowledged in accordance with customary scientific practice.
| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Title | Measurements |
|---|---|
|
| Very Dissatisfied |
|
| Title | Measurements |
|---|---|
|
| Glenoid Osteophytes Present |
|
| Humeral Component Radiolucency Present (< 1 mm) |
|
| Humeral Component Radiolucency Present (> 1 mm) |
|
| Humeral Component Osteolysis Present |
|
| Glenohumeral Subluxation Present (Slight) |
|
| Glenohumeral Subluxation Present (Moderate) |
|
| Anatomic Fracture (Present) |
|
| Glenohumeral Joint Space (< 3 mm) |
|
| Glenohumeral Joint Space (> 3 mm and < 6 mm) |
|
| Glenoid Morphology (None) |
|
| Glenoid Morphology (A1) |
|
| Glenoid Morphology (A2) |
|
| Glenoid Morphology (B1) |
|
| Glenoid Morphology (B2) |
|
| Glenoid Morphology (C) |
|
| Glenoid Morphology (Unable to assess) |
|
| Acromiohumeral Distance (> 2mm and < 7mm) |
|
| Acromiohumeral Distance (> 7mm) |
|