Arthritis
Conditions
Brief summary
This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement.
Detailed description
This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty. The investigation will be conducted by up to 10 International surgeons experienced in HRA. 387 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for 10 years.
Interventions
DEVICEPyroTITAN HRA
Humeral resurfacing using the PyroTITAN HRA device
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients selected for inclusion will present for primary shoulder surface replacement or arthroplasty with any of the following diagnoses: * Osteoarthritis * Rheumatoid / Inflammatory Arthritis * Post-traumatic arthritis. * Focal and large (Hill-Sachs) osteochondral defects. 2. Subject is able to or capable of providing consent to participate in the clinical investigation. 3. Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires. 4. Subject is at least 21 years of age and skeletally mature at the time of surgery.
Exclusion criteria
1. Have destruction of the proximal humerus to preclude rigid fixation of the humeral component. 2. Insufficient bone quality as determined by intra-operative evaluation. 3. Have arthritis with defective rotator cuff. 4. Have had a failed rotator cuff surgery. 5. Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified. 6. Have evidence of active infection. 7. Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexis injury with a flail shoulder joint). 8. Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol. 9. Are skeletally immature. 10. Have a known allergic reaction to pyrocarbon. 11. Have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible. 12. Are currently participating in another clinical study. 13. Have known, active metastatic or neoplastic disease. 14. Are taking \> 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery. 15. Are under 21 years of age or over 75. . 16. Require glenoid replacement (Glenoid Classification).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Survival | up to 117 months | Clinical success was determined by the percentage of shoulders with device survival. Survival of the device was measured by the Kaplan-Meier survival estimate with survival defined as all the following: * Device remained implanted * Absence of device-related complications requiring surgical replacement, removal, or augmentation of components * Freedom from chronic dislocation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASES Score | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years | The ASES Shoulder Score is a functional outcome tool that has been validated for various shoulder conditions. ASES score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition. |
| Visual Analog Scale (VAS) Pain Score | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years | The Visual Analog Scale (VAS) Pain Score ranges from 0 to 100, with 0 representing no pain (i.e., the best outcome) and 100 representing the worst possible pain (i.e., the worst outcome). |
| Visual Analog Scale (VAS) Satisfaction Score | 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years | Patient satisfaction determined by the Visual Analog Scale (VAS) Satisfaction score. VAS Satisfaction scores range from 0 to 100, with 0 representing the lowest level of satisfaction (i.e., the worst possible outcome) and 100 representing the highest level of satisfaction (i.e., the best possible outcome). |
| Radiographic Success | 2 years, 3 years, 4 years, 5 years, 8 years and 10 years | Radiographic success determined by: * No evidence of device failure, specifically progressive migration or implant loosening * Anatomic alignment is a criterion that may be included in the definition of success in some investigations |
| Constant-Murley (CM) Score | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years | The Constant-Murley (CM) Score is a commonly used score of shoulder function. CM scores range from 0 to 100, with a score of 0 indicating a worse shoulder function (i.e., worst outcome) and 100 indicating the best shoulder function (i.e., best outcome). |
| EQ-5D-3L Quality of Life Score | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years | The EuroQol 5-Dimension 3-Level (EQ-5D-3L) Quality of Life Score ranges on a scale of 0 to 1, with 0 indicating a worse health condition (i.e., worst outcome) and 1 indicating the best health condition (i.e., best outcome). |
| EQ-5D-3L VAS Score | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years | The EuroQol 5-Dimension 3-Level (EQ-5D-3L) Visual Analog Scale (VAS) Score ranges on a scale of 0 to 100, with 0 indicating a worse health condition (i.e., worst outcome) and 100 indicating the best health condition (i.e., best outcome). |
| The Western Ontario of the Shoulder Index (WOOS) Score | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years | The WOOS Score is a quality of life questionnaire that has been validated for various shoulder conditions. WOOS total score ranges from 0 to 100, with 0 representing the best shoulder condition and 100 representing the worst shoulder condition. |
Countries
Australia, France, Sweden, United Kingdom
Participant flow
Recruitment details
Overall, 156 participants were enrolled to the study at five (5) sites.
Pre-assignment details
The Full Analysis Set (FAS) population includes 10 participants that received the TITAN device and 146 participants that received the PyroTITAN device. The TITAN device was renamed PyroTITAN by the previous sponsor (i.e., the same device). All participants were enrolled the same based on the eligibility criteria, so all participants are combined under the same primary cohort.
Participants by arm
| Arm | Count |
|---|---|
| Primary Cohort Primary cohort will receive the PyroTITAN HRA device
PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device | 156 |
| Total | 156 |
Baseline characteristics
| Characteristic | Primary Cohort | — |
|---|---|---|
| Age, Continuous | 59.5 years STANDARD_DEVIATION 11 | — |
| Body Mass Index (BMI) | 29.00 kg/m^2 STANDARD_DEVIATION 4.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 54 Participants | — |
| Sex: Female, Male Male | 102 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 156 |
| other Total, other adverse events | 36 / 156 |
| serious Total, serious adverse events | 51 / 156 |
Outcome results
Primary
Device Survival
Clinical success was determined by the percentage of shoulders with device survival. Survival of the device was measured by the Kaplan-Meier survival estimate with survival defined as all the following: * Device remained implanted * Absence of device-related complications requiring surgical replacement, removal, or augmentation of components * Freedom from chronic dislocation
Time frame: up to 117 months
Population: Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary cohort | Device Survival | 85.97 percentage of shoulders |
Secondary
ASES Score
The ASES Shoulder Score is a functional outcome tool that has been validated for various shoulder conditions. ASES score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition.
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Population: Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary cohort | ASES Score | Baseline | 36.2 score on a scale | Standard Deviation 16.1 |
| Primary cohort | ASES Score | 3 months | 66.0 score on a scale | Standard Deviation 18.3 |
| Primary cohort | ASES Score | 6 months | 78.3 score on a scale | Standard Deviation 18.4 |
| Primary cohort | ASES Score | 1 year | 82.5 score on a scale | Standard Deviation 17.8 |
| Primary cohort | ASES Score | 2 years | 86.0 score on a scale | Standard Deviation 17.6 |
| Primary cohort | ASES Score | 3 years | 85.7 score on a scale | Standard Deviation 17.4 |
| Primary cohort | ASES Score | 4 years | 87.4 score on a scale | Standard Deviation 15.8 |
| Primary cohort | ASES Score | 5 years | 86.5 score on a scale | Standard Deviation 17.2 |
| Primary cohort | ASES Score | 8 years | 87.5 score on a scale | Standard Deviation 20.2 |
| Primary cohort | ASES Score | 10 years | 89.3 score on a scale | Standard Deviation 12.6 |
Secondary
Constant-Murley (CM) Score
The Constant-Murley (CM) Score is a commonly used score of shoulder function. CM scores range from 0 to 100, with a score of 0 indicating a worse shoulder function (i.e., worst outcome) and 100 indicating the best shoulder function (i.e., best outcome).
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Population: Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants. Data for 19 participants at 1 site excluded from analysis because data collection occurred using an incorrect CM format.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary cohort | Constant-Murley (CM) Score | Baseline | 39.4 score on a scale | Standard Deviation 17.6 |
| Primary cohort | Constant-Murley (CM) Score | 3 months | 57.3 score on a scale | Standard Deviation 18.8 |
| Primary cohort | Constant-Murley (CM) Score | 6 months | 72.5 score on a scale | Standard Deviation 17.7 |
| Primary cohort | Constant-Murley (CM) Score | 1 year | 78.8 score on a scale | Standard Deviation 16 |
| Primary cohort | Constant-Murley (CM) Score | 2 years | 82.5 score on a scale | Standard Deviation 13.4 |
| Primary cohort | Constant-Murley (CM) Score | 3 years | 81.5 score on a scale | Standard Deviation 14.1 |
| Primary cohort | Constant-Murley (CM) Score | 4 years | 82.1 score on a scale | Standard Deviation 12.1 |
| Primary cohort | Constant-Murley (CM) Score | 5 years | 82.8 score on a scale | Standard Deviation 12.3 |
| Primary cohort | Constant-Murley (CM) Score | 8 years | 83.4 score on a scale | Standard Deviation 12.4 |
| Primary cohort | Constant-Murley (CM) Score | 10 years | 80.9 score on a scale | Standard Deviation 11.6 |
Secondary
EQ-5D-3L Quality of Life Score
The EuroQol 5-Dimension 3-Level (EQ-5D-3L) Quality of Life Score ranges on a scale of 0 to 1, with 0 indicating a worse health condition (i.e., worst outcome) and 1 indicating the best health condition (i.e., best outcome).
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Population: Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants. Data for 19 participants at 1 site excluded from analysis because data collection occurred using an incorrect CM format.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary cohort | EQ-5D-3L Quality of Life Score | Baseline | 0.759 score on a scale | Standard Deviation 0.087 |
| Primary cohort | EQ-5D-3L Quality of Life Score | 3 months | 0.824 score on a scale | Standard Deviation 0.097 |
| Primary cohort | EQ-5D-3L Quality of Life Score | 6 months | 0.860 score on a scale | Standard Deviation 0.098 |
| Primary cohort | EQ-5D-3L Quality of Life Score | 1 year | 0.886 score on a scale | Standard Deviation 0.098 |
| Primary cohort | EQ-5D-3L Quality of Life Score | 2 years | 0.870 score on a scale | Standard Deviation 0.101 |
| Primary cohort | EQ-5D-3L Quality of Life Score | 3 years | 0.883 score on a scale | Standard Deviation 0.1 |
| Primary cohort | EQ-5D-3L Quality of Life Score | 4 years | 0.887 score on a scale | Standard Deviation 0.105 |
| Primary cohort | EQ-5D-3L Quality of Life Score | 5 years | 0.886 score on a scale | Standard Deviation 0.114 |
| Primary cohort | EQ-5D-3L Quality of Life Score | 8 years | 0.888 score on a scale | Standard Deviation 0.132 |
| Primary cohort | EQ-5D-3L Quality of Life Score | 10 years | 0.877 score on a scale | Standard Deviation 0.121 |
Secondary
EQ-5D-3L VAS Score
The EuroQol 5-Dimension 3-Level (EQ-5D-3L) Visual Analog Scale (VAS) Score ranges on a scale of 0 to 100, with 0 indicating a worse health condition (i.e., worst outcome) and 100 indicating the best health condition (i.e., best outcome).
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Population: Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants. Data for 19 participants at 1 site excluded from analysis because data collection occurred using an incorrect CM format.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary cohort | EQ-5D-3L VAS Score | 2 years | 75.2 score on a scale | Standard Deviation 16.4 |
| Primary cohort | EQ-5D-3L VAS Score | Baseline | 61.9 score on a scale | Standard Deviation 23.7 |
| Primary cohort | EQ-5D-3L VAS Score | 3 months | 69.0 score on a scale | Standard Deviation 19 |
| Primary cohort | EQ-5D-3L VAS Score | 6 months | 71.3 score on a scale | Standard Deviation 21.7 |
| Primary cohort | EQ-5D-3L VAS Score | 1 year | 75.7 score on a scale | Standard Deviation 17.6 |
| Primary cohort | EQ-5D-3L VAS Score | 3 years | 70.6 score on a scale | Standard Deviation 22 |
| Primary cohort | EQ-5D-3L VAS Score | 4 years | 71.9 score on a scale | Standard Deviation 19.4 |
| Primary cohort | EQ-5D-3L VAS Score | 5 years | 72.7 score on a scale | Standard Deviation 22.3 |
| Primary cohort | EQ-5D-3L VAS Score | 8 years | 76.8 score on a scale | Standard Deviation 17.9 |
| Primary cohort | EQ-5D-3L VAS Score | 10 years | 73.2 score on a scale | Standard Deviation 18.8 |
Secondary
Radiographic Success
Radiographic success determined by: * No evidence of device failure, specifically progressive migration or implant loosening * Anatomic alignment is a criterion that may be included in the definition of success in some investigations
Time frame: 2 years, 3 years, 4 years, 5 years, 8 years and 10 years
Population: Radiographic outcome data were not collected during the study period by the original sponsor, despite being specified in the protocol. As a result, this outcome measure could not be analyzed or reported. This limitation does not affect the reporting of other pre-specified primary and secondary outcomes, which have been summarized and submitted as per protocol.
Secondary
The Western Ontario of the Shoulder Index (WOOS) Score
The WOOS Score is a quality of life questionnaire that has been validated for various shoulder conditions. WOOS total score ranges from 0 to 100, with 0 representing the best shoulder condition and 100 representing the worst shoulder condition.
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Population: Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary cohort | The Western Ontario of the Shoulder Index (WOOS) Score | Baseline | 65.1 score on a scale | Standard Deviation 15 |
| Primary cohort | The Western Ontario of the Shoulder Index (WOOS) Score | 3 months | 34.3 score on a scale | Standard Deviation 19.9 |
| Primary cohort | The Western Ontario of the Shoulder Index (WOOS) Score | 6 months | 22.2 score on a scale | Standard Deviation 19.2 |
| Primary cohort | The Western Ontario of the Shoulder Index (WOOS) Score | 1 year | 18.6 score on a scale | Standard Deviation 19.5 |
| Primary cohort | The Western Ontario of the Shoulder Index (WOOS) Score | 2 years | 15.3 score on a scale | Standard Deviation 19.3 |
| Primary cohort | The Western Ontario of the Shoulder Index (WOOS) Score | 3 years | 15.2 score on a scale | Standard Deviation 17 |
| Primary cohort | The Western Ontario of the Shoulder Index (WOOS) Score | 4 years | 14.2 score on a scale | Standard Deviation 16.8 |
| Primary cohort | The Western Ontario of the Shoulder Index (WOOS) Score | 5 years | 13.8 score on a scale | Standard Deviation 15.6 |
| Primary cohort | The Western Ontario of the Shoulder Index (WOOS) Score | 8 years | 12.6 score on a scale | Standard Deviation 19.9 |
| Primary cohort | The Western Ontario of the Shoulder Index (WOOS) Score | 10 years | 11.8 score on a scale | Standard Deviation 13.9 |
Secondary
Visual Analog Scale (VAS) Pain Score
The Visual Analog Scale (VAS) Pain Score ranges from 0 to 100, with 0 representing no pain (i.e., the best outcome) and 100 representing the worst possible pain (i.e., the worst outcome).
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Population: Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary cohort | Visual Analog Scale (VAS) Pain Score | 5 years | 13.4 score on a scale | Standard Deviation 19.6 |
| Primary cohort | Visual Analog Scale (VAS) Pain Score | Baseline | 64.1 score on a scale | Standard Deviation 20.3 |
| Primary cohort | Visual Analog Scale (VAS) Pain Score | 3 months | 24.2 score on a scale | Standard Deviation 21.1 |
| Primary cohort | Visual Analog Scale (VAS) Pain Score | 6 months | 18.1 score on a scale | Standard Deviation 20.2 |
| Primary cohort | Visual Analog Scale (VAS) Pain Score | 1 year | 15.5 score on a scale | Standard Deviation 19.5 |
| Primary cohort | Visual Analog Scale (VAS) Pain Score | 2 years | 13.2 score on a scale | Standard Deviation 19.4 |
| Primary cohort | Visual Analog Scale (VAS) Pain Score | 3 years | 15.5 score on a scale | Standard Deviation 21.2 |
| Primary cohort | Visual Analog Scale (VAS) Pain Score | 4 years | 12.1 score on a scale | Standard Deviation 18.1 |
| Primary cohort | Visual Analog Scale (VAS) Pain Score | 8 years | 12.7 score on a scale | Standard Deviation 21.9 |
| Primary cohort | Visual Analog Scale (VAS) Pain Score | 10 years | 9.2 score on a scale | Standard Deviation 12 |
Secondary
Visual Analog Scale (VAS) Satisfaction Score
Patient satisfaction determined by the Visual Analog Scale (VAS) Satisfaction score. VAS Satisfaction scores range from 0 to 100, with 0 representing the lowest level of satisfaction (i.e., the worst possible outcome) and 100 representing the highest level of satisfaction (i.e., the best possible outcome).
Time frame: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Population: Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary cohort | Visual Analog Scale (VAS) Satisfaction Score | 3 months | 75.8 score on a scale | Standard Deviation 25.1 |
| Primary cohort | Visual Analog Scale (VAS) Satisfaction Score | 6 months | 81.1 score on a scale | Standard Deviation 23.3 |
| Primary cohort | Visual Analog Scale (VAS) Satisfaction Score | 1 year | 84.0 score on a scale | Standard Deviation 21.8 |
| Primary cohort | Visual Analog Scale (VAS) Satisfaction Score | 2 years | 85.6 score on a scale | Standard Deviation 21.8 |
| Primary cohort | Visual Analog Scale (VAS) Satisfaction Score | 3 years | 85.6 score on a scale | Standard Deviation 19.6 |
| Primary cohort | Visual Analog Scale (VAS) Satisfaction Score | 4 years | 86.3 score on a scale | Standard Deviation 18.5 |
| Primary cohort | Visual Analog Scale (VAS) Satisfaction Score | 5 years | 86.1 score on a scale | Standard Deviation 21.3 |
| Primary cohort | Visual Analog Scale (VAS) Satisfaction Score | 8 years | 86.2 score on a scale | Standard Deviation 24.2 |
| Primary cohort | Visual Analog Scale (VAS) Satisfaction Score | 10 years | 88.6 score on a scale | Standard Deviation 18 |