Rheumatoid Arthritis Clinical Trial
Official title:
Comprehensive Nano Post Market Data Collection
Verified date | October 2023 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 194 |
Est. completion date | July 31, 2030 |
Est. primary completion date | July 31, 2030 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Privatklinik Leech | Graz | Styria |
Canada | Kingston General Hospital | Kingston | Ontario |
Korea, Republic of | Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Samsung Medical Centre | Seoul | |
United Kingdom | University of Liverpool | Liverpool | Merseyside |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
Austria, Canada, Korea, Republic of, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survivorship | Kaplan Meier method | 10 years | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | X-rays evaluated for radiolucencies, osteolysis, migration and subsidence | Standard evaluation performed on both humeral and glenoid components | 10 years |
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