Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06546332

Post Market Clinical Follow-Up KeriFuse®

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de la main du Pays d'Aix, Aix-en-Provence, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Pain and radiological assessment

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Keri Medical SA

Industry

Registry information

Official study title

Effectiveness and Safety of the KeriFuse® Intramedullary Arthrodesis Implant and Associated Instruments in the Treatment of IP or DIP Arthritis: a Post Market Clinical Follow-up.

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.