Arthritis
Conditions
Brief summary
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.
Interventions
DEVICEKeriFuse®
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.
Sponsors
Keri Medical SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years, * Patients that will have a surgery using a KeriFuse® implant in accordance with the approved labelling and IFU.
Exclusion criteria
* Pregnant or nursing women, * Patients with intellectual disabilities who cannot follow the instructions of their surgeon, * Patients with a contraindication to surgery and more specifically to the implantation of KeriFuse®, * Patients with acute or chronic infections, local or systemic, * Patients with sensitivities or allergies to the implant components (Nickel, Titanium).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain and radiological assessment | 3 months | 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) |
Countries
France
Outcome results
None listed