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

NCT ID: NCT06151834

Last Updated: 2025-02-13

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Osteoarthritis Finger Osteoarthritis Thumb

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients

Patients older than 18 years-old, with a surgical indication of interphalangeal arthrodesis of finger

Group Type EXPERIMENTAL

KeriFuse implant implantation

Intervention Type PROCEDURE

The surgery is an arthrodesis of finger or thumb (for patients with finger osteoarthritis) and involves implanting the KeriFuse implant.

Interventions

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KeriFuse implant implantation

The surgery is an arthrodesis of finger or thumb (for patients with finger osteoarthritis) and involves implanting the KeriFuse implant.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Eligible patients with osteoarthritis of finger for an interphalangeal arthrodesis with KeriFuse implant

Exclusion Criteria

* Pregnant or breastfeeding patient
* Patient with an intellectual disability and who therefore cannot follow the surgeon'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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Saint François, Nice, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Saint François

Nice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nicolas DREANT, MD

Role: CONTACT

+334 93 13 68 31

Facility Contacts

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Valentine Lammens

Role: primary

+334.93.13.65.00

Other Identifiers

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2023-A02072-43

Identifier Type: -

Identifier Source: org_study_id

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