Avascular Necrosis, Correction of Functional Deformity, Osteoarthritis, Revision, Rheumatoid Arthritis
Conditions
Keywords
osteoarthritis, avascular necrosis, rheumatoid arthritis
Brief summary
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
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.
Interventions
DEVICEComprehensive Nano
Patients requiring the Comprehensive Nano shoulder system.
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship | 10 years | Kaplan Meier method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASES Score (American Shoulder and Elbow Surgeons) | 10 years | 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"). |
| SANE Score (Single Assessment Numeric Evaluation) | 10 years | 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)?" |
| Constant-Murley Score | 10 years | Improvement in this score from preop to 10 year follow-up. This is a 100-point score. Higher scores indicate a better outcome. |
| X-rays evaluated for radiolucencies, osteolysis, migration and subsidence | 10 years | Standard evaluation performed on both humeral and glenoid components |
Countries
Austria, Canada, South Korea, United Kingdom
Contacts
STUDY_DIRECTORPaola Vivoda
Zimmer Biomet
Outcome results
None listed