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.
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.
Study Type
OBSERVATIONAL
Enrollment
156
Humeral resurfacing using the PyroTITAN HRA device
Brisbane Hand & Upper Limb Clinic
Brisbane, Queensland, Australia
Barwon Health
Geelong, Victoria, Australia
Institut Nices
Nice, France
Danderyd Hospital
Stockholm, Sweden
Wrightington Hospital
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
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
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
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
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).
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Wigan, Wrightington, United Kingdom
Time frame: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
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
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
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
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