Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device

Last updated: February 11, 2025
Sponsor: Clinique Saint François, Nice, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

KeriFuse implant implantation

Clinical Study ID

NCT06151834
2023-A02072-43
  • Ages > 18
  • All Genders

Study Summary

Arthrodesis of a distal interphalangeal joint of the finger (DIP) is mainly performed for a degenerated and painful joint. Various stabilization methods have been used to provide compression at the arthrodesis site such as pins, steel wires, compression screws, headless compression screws, bioresorbable implants and intramedullary staples.

Although with complications such as implant fractures or dorsal cortical erosion, intramedullary arthrodesis staples provide reliable pain relief and a consistent fusion rate while inevitably scarring the finger pulp or nail dystrophy.

The aim of this study is to evaluate the bone fusion time during an arthrodesis performed with the Kerifuse shape memory implant.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible patients with osteoarthritis of finger for an interphalangeal arthrodesiswith KeriFuse implant

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding patient

  • Patient with an intellectual disability and who therefore cannot follow thesurgeon's instructions

  • Patients with contraindications to surgery

  • Patients with acute or chronic, local or systemic infections

  • Patients with sensitivities or allergies to device components (Nickel, Titanium)

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: KeriFuse implant implantation
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
September 01, 2026

Study Description

Arthrodesis of a distal interphalangeal joint of the finger (DIP) is mainly performed for a degenerated and painful joint. Various stabilization methods have been used to provide compression at the arthrodesis site such as pins, steel wires, compression screws, headless compression screws, bioresorbable implants and intramedullary staples.

Although with complications such as implant fractures or dorsal cortical erosion, intramedullary arthrodesis staples provide reliable pain relief and a consistent fusion rate while inevitably scarring the finger pulp or nail dystrophy.

The aim of this study is to evaluate the bone fusion time during an arthrodesis performed with the Kerifuse shape memory implant.

Main objective is to evaluate the bone fusion time in arthrodesis performed with the Kerifuse shape memory implant.

Secondary objectives are :

  • to evaluate the fusion rate and its associated healing time

  • to evaluate patient satisfaction, including aesthetic aspect

  • to assess overall hand function

  • to evaluate the radiological evolution of the KeriFuse® implant and its implantation site

  • To evaluate the radiological evolution of the arthrodesis angle between the post-operative situation and the final fusion position

Connect with a study center

  • Clinique Saint François

    Nice, 06000
    France

    Active - Recruiting

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