Trial Outcomes & Findings for Aequalis Pyrocarbon IDE; Replacing the Humeral Head in Hemi-Arthroplasty (NCT NCT02525783)
NCT ID: NCT02525783
Last Updated: 2023-01-19
Results Overview
A subject is a success at 24 months if: * Their change in Constant score is greater than or equal to 17 and * They did not have revision surgery; and * There is no radiographic evidence of system disassembly or fracture, and * They did not have a system-related serious adverse event.
COMPLETED
157 participants
24 Months
2023-01-19
Participant Flow
Participant milestones
| Measure |
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.
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Overall Study
STARTED
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157
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Overall Study
COMPLETED
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147
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Overall Study
NOT COMPLETED
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10
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Reasons for withdrawal
| Measure |
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.
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Overall Study
Lost to Follow-up
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10
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tornier Pyrocarbon Humeral Head
n=157 Participants
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.
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Age, Continuous
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52.1 years
STANDARD_DEVIATION 10.8 • n=157 Participants
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Sex: Female, Male
Female
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33 Participants
n=157 Participants
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Sex: Female, Male
Male
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124 Participants
n=157 Participants
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Constant Score
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42.6 units on a scale
STANDARD_DEVIATION 15.0 • n=157 Participants
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PRIMARY outcome
Timeframe: 24 MonthsPopulation: 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.
A subject is a success at 24 months if: * Their change in Constant score is greater than or equal to 17 and * They did not have revision surgery; and * There is no radiographic evidence of system disassembly or fracture, and * They did not have a system-related serious adverse event.
Outcome measures
| Measure |
Tornier Pyrocarbon Humeral Head
n=146 Participants
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.
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Rate of Patient Success at 24 Months.
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120 Participants
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SECONDARY outcome
Timeframe: 24 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Tornier Pyrocarbon Humeral Head
n=143 Participants
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.
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Constant Score
Constant Score Increase (change in score)
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34.3 units on a scale
Standard Deviation 17.8
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Constant Score
Adjusted Constant Score Increase (change in score)
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39.5 units on a scale
Standard Deviation 20.5
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Constant Score
Constant Score (Absolute value)
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78.1 units on a scale
Standard Deviation 16.4
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SECONDARY outcome
Timeframe: 24 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Tornier Pyrocarbon Humeral Head
n=144 Participants
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.
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American Shoulder and Elbow Surgeons (ASES) Score
ASES Score Increase (Change from Baseline)
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43.4 units on a scale
Standard Deviation 21.7
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American Shoulder and Elbow Surgeons (ASES) Score
ASES Score (Absolute value)
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87.5 units on a scale
Standard Deviation 17.5
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SECONDARY outcome
Timeframe: 24 MonthsPopulation: 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.
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
Outcome measures
| Measure |
Tornier Pyrocarbon Humeral Head
n=144 Participants
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.
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Single Assessment Numeric Evaluation (SANE)
SANE Score Increase (Change from baseline)
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49.5 score on a scale
Standard Deviation 26
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Single Assessment Numeric Evaluation (SANE)
SANE Score (Absolute Value)
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85.4 score on a scale
Standard Deviation 19.1
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SECONDARY outcome
Timeframe: 24 MonthsPopulation: 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.
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
Outcome measures
| Measure |
Tornier Pyrocarbon Humeral Head
n=144 Participants
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.
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EQ-5D Index
EQ-5D Increase (Change from baseline)
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.21 units on a scale
Standard Deviation .15
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EQ-5D Index
EQ-5D (Absolute value)
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.87 units on a scale
Standard Deviation .14
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SECONDARY outcome
Timeframe: 24 MonthsPopulation: 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.
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
Outcome measures
| Measure |
Tornier Pyrocarbon Humeral Head
n=144 Participants
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.
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Pain Measured by a VIsual Analog Scale (VAS)
Change in Pain by VAS reported (decrease in pain)
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4.23 score on a scale
Standard Deviation 2.84
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Pain Measured by a VIsual Analog Scale (VAS)
Pain by VAS (Absolute value)
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1.14 score on a scale
Standard Deviation 1.88
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SECONDARY outcome
Timeframe: 24 MonthsPopulation: 144 patients were analyzed as 10 patients were lost to follow-up and three patients were revised prior to a 24-month visit.
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. * Forward Flexion * Abduction * External Rotation
Outcome measures
| Measure |
Tornier Pyrocarbon Humeral Head
n=144 Participants
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.
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Range of Motion (ROM)
Forward Flexion Increase
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33.5 Degrees
Standard Deviation 31.5
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Range of Motion (ROM)
Abduction Increase
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43.5 Degrees
Standard Deviation 37.3
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Range of Motion (ROM)
External Rotation Increase
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37.5 Degrees
Standard Deviation 28.6
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SECONDARY outcome
Timeframe: 24 MonthsPopulation: 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.
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
Outcome measures
| Measure |
Tornier Pyrocarbon Humeral Head
n=144 Participants
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.
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Strength
Increase in Strength
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5 Pounds
Standard Deviation 7.6
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Strength
Strength (Absolute value)
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14.8 Pounds
Standard Deviation 6.8
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SECONDARY outcome
Timeframe: 24 MonthsPopulation: Device-related Serious Adverse Events
Adverse Events data will be collected and summarized at 24 months.
Outcome measures
| Measure |
Tornier Pyrocarbon Humeral Head
n=157 Participants
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.
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Number of Participants With Device-related Serious Adverse Events
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5 Participants
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SECONDARY outcome
Timeframe: 24 MonthsPopulation: 147 were analyzed as 10 patients were lost to follow-up.
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.
Outcome measures
| Measure |
Tornier Pyrocarbon Humeral Head
n=147 Participants
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.
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Revision Rate
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3 Participants
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SECONDARY outcome
Timeframe: 24 MonthsThe level of satisfaction with the shoulder will be summarized at 24 months.
Outcome measures
| Measure |
Tornier Pyrocarbon Humeral Head
n=144 Participants
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.
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Level of Satisfaction With the Shoulder
Very Satisfied
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111 Participants
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Level of Satisfaction With the Shoulder
Satisfied
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20 Participants
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Level of Satisfaction With the Shoulder
Dissatisfied
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8 Participants
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Level of Satisfaction With the Shoulder
Very Dissatisfied
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5 Participants
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SECONDARY outcome
Timeframe: 24 MonthsPopulation: 144 subjects were analyzed as 10 subjects were lost to follow-up and three patients were revised prior to a 24-month visit.
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
Outcome measures
| Measure |
Tornier Pyrocarbon Humeral Head
n=144 Participants
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.
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X-Ray Data
Humeral Component Migration
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0 Participants
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X-Ray Data
Humeral Component Subsidence
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0 Participants
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X-Ray Data
Humeral Head Integrity
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0 Participants
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X-Ray Data
Glenoid Osteophytes Present
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78 Participants
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X-Ray Data
Humeral Component Radiolucency Present (< 1 mm)
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5 Participants
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X-Ray Data
Humeral Component Radiolucency Present (> 1 mm)
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0 Participants
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X-Ray Data
Humeral Component Osteolysis Present
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0 Participants
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X-Ray Data
Glenohumeral Subluxation Present (Slight)
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1 Participants
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X-Ray Data
Glenohumeral Subluxation Present (Moderate)
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0 Participants
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X-Ray Data
Anatomic Fracture (Present)
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1 Participants
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X-Ray Data
Glenohumeral Joint Space (< 3 mm)
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120 Participants
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X-Ray Data
Glenohumeral Joint Space (> 3 mm and < 6 mm)
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24 Participants
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X-Ray Data
Glenoid Morphology (None)
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25 Participants
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X-Ray Data
Glenoid Morphology (A1)
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58 Participants
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X-Ray Data
Glenoid Morphology (A2)
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40 Participants
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X-Ray Data
Glenoid Morphology (B1)
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4 Participants
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X-Ray Data
Glenoid Morphology (B2)
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14 Participants
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X-Ray Data
Glenoid Morphology (C)
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2 Participants
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X-Ray Data
Glenoid Morphology (Unable to assess)
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1 Participants
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X-Ray Data
Acromiohumeral Distance (> 2mm and < 7mm)
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31 Participants
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X-Ray Data
Acromiohumeral Distance (> 7mm)
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113 Participants
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Adverse Events
Tornier Pyrocarbon Humeral Head
Serious adverse events
| Measure |
Tornier Pyrocarbon Humeral Head
n=157 participants at risk
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.
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Musculoskeletal and connective tissue disorders
ARTHROFIBROSIS, TREATED SHOULDER
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0.64%
1/157 • Number of events 1 • 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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Musculoskeletal and connective tissue disorders
UNEXPECTED POSITIVE CULTURE
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0.64%
1/157 • Number of events 1 • 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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Musculoskeletal and connective tissue disorders
ROTATOR CUFF TEAR, TREATED SHOULDER
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1.3%
2/157 • Number of events 2 • 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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Musculoskeletal and connective tissue disorders
PAIN, TREATED SHOULDER; INFECTION, TREATED SHOULDER
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0.64%
1/157 • Number of events 1 • 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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Musculoskeletal and connective tissue disorders
Pain, Treated Shoulder; MVC; Cervical Spondylosis
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0.64%
1/157 • Number of events 1 • 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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Other adverse events
| Measure |
Tornier Pyrocarbon Humeral Head
n=157 participants at risk
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.
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|---|---|
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Musculoskeletal and connective tissue disorders
Pain, Treated Shoulder
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13.4%
21/157 • Number of events 25 • 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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Musculoskeletal and connective tissue disorders
Pain, Contralateral Shoulder
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15.3%
24/157 • Number of events 24 • 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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Musculoskeletal and connective tissue disorders
OA, in other non-study shoulder joints
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6.4%
10/157 • Number of events 10 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER