Avascular Necrosis, Osteoarthritis, Traumatic Arthritis
Conditions
Brief summary
The purpose of this study is to demonstrate safety and effectiveness of the Aequalis Pyrocarbon Humeral Head in hemiarthroplasty at 24 months.
Interventions
Hemi Shoulder Arthroplasty
Sponsors
Stryker Trauma and Extremities
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult subject 22 years or older. * Scapula and proximal humerus must have reached skeletal maturity. * Clinical indication for hemiarthroplasty due to primary diagnosis of arthritis or avascular necrosis. Primary arthritis for this study includes osteoarthritis with pain and/or post-traumatic arthritis. * Willing and able to comply with the protocol. * Willing and able to sign the informed consent formed (or the Legally Authorized Representative will sign for the subject).
Exclusion criteria
* Active local or systemic infection, sepsis, or osteomyelitis. * In the opinion of the clinician, there is insufficient bone stock to support implants in the humeral metaphysis or poor bone quality. * In the opinion of the clinician, there is insufficient bone stock or excessive deformation of the native glenoid to allow normal functioning of the glenohumeral joint. * In the clinician's opinion, the subject is unwilling or unable to be compliant with the recommendations of the healthcare professional. * Metabolism disorders that could compromise bone formation, or Osteomalacia. * Infection at or near the implant site, distant foci of infections that could spread to the site of the implant, or systemic infection. * Rapid destruction of the joint, marked bone loss, or bone resorption apparent on X-ray. * Known allergy or suspected allergy to implant materials. * Female subjects who are pregnant or planning to become pregnant within the study period. * Medical conditions or balance impairments that could lead to falls. Prior arthroplasty or prior failed rotator cuff repair on the affected shoulder; (successful rotator cuff surgery may be included). * A rotator cuff that is not intact and cannot be reconstructed. Subjects with a massive rotator cuff tear (\>5cm) will be excluded. * Nonfunctional deltoid muscle. * Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint). * Known active metastatic or neoplastic diseases, Paget's disease, or Charcot's disease. * Currently, within the last 6 months, or planning to be on chemotherapy or radiation. * Known alcohol or drug abuse as defined by DSM-5. * Taking greater than 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery. * Currently enrolled in any clinical research study that might interfere with the current study endpoints. * Known history of renal or hepatic disease/insufficiency. * Anatomy cannot be replicated using current available system sizes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Patient Success at 24 Months. | 24 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) Score | 24 Months | 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. |
| Single Assessment Numeric Evaluation (SANE) | 24 Months | 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 |
| EQ-5D Index | 24 Months | 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 |
| Pain Measured by a VIsual Analog Scale (VAS) | 24 Months | 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 |
| Range of Motion (ROM) | 24 Months | 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 |
| Constant Score | 24 Months | 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. |
| Number of Participants With Device-related Serious Adverse Events | 24 Months | Adverse Events data will be collected and summarized at 24 months. |
| Revision Rate | 24 Months | 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. |
| Level of Satisfaction With the Shoulder | 24 Months | The level of satisfaction with the shoulder will be summarized at 24 months. |
| X-Ray Data | 24 Months | 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 |
| Strength | 24 Months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 157 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 10 |
Baseline characteristics
| Characteristic | Tornier Pyrocarbon Humeral Head | — |
|---|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 10.8 | — |
| Constant Score | 42.6 units on a scale STANDARD_DEVIATION 15 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 33 Participants | — |
| Sex: Female, Male Male | 124 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 157 |
| other Total, other adverse events | 45 / 157 |
| serious Total, serious adverse events | 5 / 157 |
Outcome results
Primary
Rate of Patient Success at 24 Months.
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.
Time frame: 24 Months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tornier Pyrocarbon Humeral Head | Rate of Patient Success at 24 Months. | 120 Participants |
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.
Time frame: 24 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tornier Pyrocarbon Humeral Head | American Shoulder and Elbow Surgeons (ASES) Score | ASES Score Increase (Change from Baseline) | 43.4 units on a scale | Standard Deviation 21.7 |
| Tornier Pyrocarbon Humeral Head | American Shoulder and Elbow Surgeons (ASES) Score | ASES Score (Absolute value) | 87.5 units on a scale | Standard Deviation 17.5 |
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.
Time frame: 24 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tornier Pyrocarbon Humeral Head | Constant Score | Constant Score Increase (change in score) | 34.3 units on a scale | Standard Deviation 17.8 |
| Tornier Pyrocarbon Humeral Head | Constant Score | Adjusted Constant Score Increase (change in score) | 39.5 units on a scale | Standard Deviation 20.5 |
| Tornier Pyrocarbon Humeral Head | Constant Score | Constant Score (Absolute value) | 78.1 units on a scale | Standard Deviation 16.4 |
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
Time frame: 24 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tornier Pyrocarbon Humeral Head | EQ-5D Index | EQ-5D Increase (Change from baseline) | .21 units on a scale | Standard Deviation 0.15 |
| Tornier Pyrocarbon Humeral Head | EQ-5D Index | EQ-5D (Absolute value) | .87 units on a scale | Standard Deviation 0.14 |
Secondary
Level of Satisfaction With the Shoulder
The level of satisfaction with the shoulder will be summarized at 24 months.
Time frame: 24 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tornier Pyrocarbon Humeral Head | Level of Satisfaction With the Shoulder | Very Satisfied | 111 Participants |
| Tornier Pyrocarbon Humeral Head | Level of Satisfaction With the Shoulder | Satisfied | 20 Participants |
| Tornier Pyrocarbon Humeral Head | Level of Satisfaction With the Shoulder | Dissatisfied | 8 Participants |
| Tornier Pyrocarbon Humeral Head | Level of Satisfaction With the Shoulder | Very Dissatisfied | 5 Participants |
Secondary
Number of Participants With Device-related Serious Adverse Events
Adverse Events data will be collected and summarized at 24 months.
Time frame: 24 Months
Population: Device-related Serious Adverse Events
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tornier Pyrocarbon Humeral Head | Number of Participants With Device-related Serious Adverse Events | 5 Participants |
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
Time frame: 24 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tornier Pyrocarbon Humeral Head | Pain Measured by a VIsual Analog Scale (VAS) | Change in Pain by VAS reported (decrease in pain) | 4.23 score on a scale | Standard Deviation 2.84 |
| Tornier Pyrocarbon Humeral Head | Pain Measured by a VIsual Analog Scale (VAS) | Pain by VAS (Absolute value) | 1.14 score on a scale | Standard Deviation 1.88 |
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. * Forward Flexion * Abduction * External Rotation
Time frame: 24 Months
Population: 144 patients were analyzed as 10 patients were lost to follow-up and three patients were revised prior to a 24-month visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tornier Pyrocarbon Humeral Head | Range of Motion (ROM) | Forward Flexion Increase | 33.5 Degrees | Standard Deviation 31.5 |
| Tornier Pyrocarbon Humeral Head | Range of Motion (ROM) | Abduction Increase | 43.5 Degrees | Standard Deviation 37.3 |
| Tornier Pyrocarbon Humeral Head | Range of Motion (ROM) | External Rotation Increase | 37.5 Degrees | Standard Deviation 28.6 |
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.
Time frame: 24 Months
Population: 147 were analyzed as 10 patients were lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tornier Pyrocarbon Humeral Head | Revision Rate | 3 Participants |
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
Time frame: 24 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tornier Pyrocarbon Humeral Head | Single Assessment Numeric Evaluation (SANE) | SANE Score Increase (Change from baseline) | 49.5 score on a scale | Standard Deviation 26 |
| Tornier Pyrocarbon Humeral Head | Single Assessment Numeric Evaluation (SANE) | SANE Score (Absolute Value) | 85.4 score on a scale | Standard Deviation 19.1 |
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
Time frame: 24 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tornier Pyrocarbon Humeral Head | Strength | Increase in Strength | 5 Pounds | Standard Deviation 7.6 |
| Tornier Pyrocarbon Humeral Head | Strength | Strength (Absolute value) | 14.8 Pounds | Standard Deviation 6.8 |
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
Time frame: 24 Months
Population: 144 subjects were analyzed as 10 subjects were lost to follow-up and three patients were revised prior to a 24-month visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Glenohumeral Subluxation Present (Moderate) | 0 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Anatomic Fracture (Present) | 1 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Glenohumeral Joint Space (< 3 mm) | 120 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Glenohumeral Joint Space (> 3 mm and < 6 mm) | 24 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Acromiohumeral Distance (> 7mm) | 113 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Humeral Component Migration | 0 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Humeral Component Subsidence | 0 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Humeral Head Integrity | 0 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Glenoid Osteophytes Present | 78 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Humeral Component Radiolucency Present (< 1 mm) | 5 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Humeral Component Radiolucency Present (> 1 mm) | 0 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Humeral Component Osteolysis Present | 0 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Glenohumeral Subluxation Present (Slight) | 1 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Glenoid Morphology (None) | 25 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Glenoid Morphology (A1) | 58 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Glenoid Morphology (A2) | 40 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Glenoid Morphology (B1) | 4 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Glenoid Morphology (B2) | 14 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Glenoid Morphology (C) | 2 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Glenoid Morphology (Unable to assess) | 1 Participants |
| Tornier Pyrocarbon Humeral Head | X-Ray Data | Acromiohumeral Distance (> 2mm and < 7mm) | 31 Participants |