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The general objective of this study is to evaluate the performances and the safety related to the KeriFuse® intramedullary arthrodesis implant and associated instrumentation used in accordance with their approved labelling and instruction for use. Performance and safety of KeriFuse® intramedullary arthrodesis implant will be established on short and middle-terms in regards to the implant life-cycle.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KeriFuse® | Device | The intramedullary arthrodesis Implant (KeriFuse®) is indicated for consolidation or bone fusion (arthrodesis) of degraded or arthritic distal interphalangeal (DIP) of hand digits or interphalangeal (IP) joint of the hand thumb. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and radiological assessment | At 3 months postoperatively, the proportion of patients with a pain level ≤ 3 on VAS (ranking from 0 to 10 cm) and with a fused DIP or IP joint (radiological assessment) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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The intended target population for the KeriFuse® and associated instruments is an adult population requiring a surgical treatment claimed by the device and presenting bone quality deemed satisfactory by the surgeon.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de la main du Pays d'Aix | Aix-en-Provence | 13090 | France | |||
| Clinique de la Chataigneraie |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Beaumont |
| 63110 |
| France |
| Centre Ostéo Articulaire Fleming | Bourgoin | 38300 | France |
| Clinique Saint François | Nice | 06000 | France |
| Clinique Mutualiste Catalane | Perpignan | 66000 | France |
| Clinique du Parc | Périgueux | 24000 | France |