Comprehensive Nano - Post Market Clinical Follow-Up Study

Study Overview
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Brief Summary
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This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.

Detailed Description
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The Comprehensive® Shoulder System with Nano humeral component is a humeral prosthesis system intended for use in total or hemi shoulder arthroplasty surgery. Total shoulder arthroplasty consists of replacement of the humeral head and glenoid. Hemi-arthroplasty consists of replacement of only the humeral head. This project is a prospective study including one-hundred and fifty (150) anatomic and hemi cases and 44 reverse shoulders collected from up to ten (10) sites. All potential study subjects will be required to participate in the Informed Consent process.

Official Title
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Comprehensive Nano Post Market Data Collection

Conditions
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Avascular Necrosis, Rheumatoid Arthritis, Revision, Correction of Functional Deformity, Osteoarthritis

Intervention / Treatment
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* Device: Comprehensive Nano


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. Rheumatoid arthritis Revision where other devices or treatments have failed Correction of functional deformity. Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate Exclusion Criteria: Infection Sepsis osteomyelitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anatomic<br>Patients receiving the Anatomic or Hemi verison of the Comprehensive Nano. | Device: Comprehensive Nano<br>* Patients requiring the Comprehensive Nano shoulder system.<br>|
| Reverse<br>Patients who have received the Reverse version of the Comprehensive Nano. | Device: Comprehensive Nano<br>* Patients requiring the Comprehensive Nano shoulder system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship | Kaplan Meier method | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASES Score (American Shoulder and Elbow Surgeons) | Improvement in this score from preop to 10 year follow-up. This score includes 2 scales: 1 scale for pain, from 0 to 10 where 0 stands for no pain at all and 10 for pain as bad as it can be. The second scale is for the stability of the shoulder, from 0 to 10 (0 stands for very stable and 10 for very unstable). | 10 years | 
| SANE Score (Single Assessment Numeric Evaluation) | Improvement in this score from preop to 10 year follow-up. This is a simple, single-question, patient-based shoulder function assessment tool: How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)? | 10 years | 
| Constant-Murley Score | Improvement in this score from preop to 10 year follow-up. This is a 100-point score. Higher scores indicate a better outcome. | 10 years | 
| X-rays evaluated for radiolucencies, osteolysis, migration and subsidence | Standard evaluation performed on both humeral and glenoid components | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, avascular necrosis, rheumatoid arthritis