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The general objective of this study is to assess the performance and safety of the KeriFlex® silicone joint implant and its associated instruments, used in accordance with the labeling and instructions in force.
The performance and safety of the KeriFlex® joint implant will be established in the short and long term with regard to the life cycle of the implant.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KeriFlex® | Device | The KeriFlex® finger joint prothesis MCP is designed to replace a damaged metacarpophalangeal (MCP) joint and the KeriFlex® finger joint prothesis PIP is designed to replace a damaged proximal interphalangeal (PIP) joint. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand | Proportion of patients with a bMHQ score greater than the preoperative value at 6 months (postoperative). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Any type of population requiring a surgical procedure covered by the device and presenting bone quality deemed satisfactory by the surgeon.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CAUX | Contact | 058 255 01 30 | +41 | clinic@kerimedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Jean Minjoz | Recruiting | Besançon | 25030 | France |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Clinic Lille Sud | Recruiting | Lesquin | 59813 | France |
|
| Institut aquitain de la main et du membre supérieur | Recruiting | Pessac | 33600 | France |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |