Post Market Clinical Follow-Up KeriFuse®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-05

Study Completion Date

2027-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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KeriFuse®

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.

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No