A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing

Conditions
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Arthritis

Intervention / Treatment
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* Device: PyroTITAN HRA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Subject is able to or capable of providing consent to participate in the clinical investigation. Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires. Subject is at least 21 years of age and skeletally mature at the time of surgery. Exclusion Criteria: Have destruction of the proximal humerus to preclude rigid fixation of the humeral component. Insufficient bone quality as determined by intra-operative evaluation. Have arthritis with defective rotator cuff. Have had a failed rotator cuff surgery. Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified. Have evidence of active infection. Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexis injury with a flail shoulder joint). 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. Are skeletally immature. Have a known allergic reaction to pyrocarbon. 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. Are currently participating in another clinical study. Have known, active metastatic or neoplastic disease. Are taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery. Are under 21 years of age or over 75. . Require glenoid replacement (Glenoid Classification).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary cohort<br>Primary cohort will receive the PyroTITAN HRA device | Device: PyroTITAN HRA<br>* Humeral resurfacing using the PyroTITAN HRA device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASES | The ASES Shoulder Score is a functional outcome tool that has been validated for various shoulder conditions | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The WOOS score | The WOOS Score is a quality of life questionnaire that has been validated for various shoulder conditions. | 2 years | 
| Visual Analog Scale (VAS) | The Visual Analog Scale (VAS) form assesses pain, shoulder pain and satisfaction as it relates to the effected shoulder. | 2 years | 
| EQ 5D | The EQ-5D Questionnaire consists of information pertaining to the current health status of the patient at the time of evaluation. | 2 years | 
| The Constant Score | The Constant Score is a commonly used score of shoulder function. | 2 years | 
| Improvement in joint range of motion | Assesses the range of motion in the shoulder | 2 years | 
| No evidence of device failure on X-rays | true anterior-posterior in the scapular plane, internal and external rotation, axial lateral and an axillary lateral view. | 2 years | 
| Number of participants with adverse events | to assess the safety of the device | 2 years |