Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device (KF23)

Clinique Saint François, Nice, France

Status: Enrolling

Conditions: Osteoarthritis Finger; Osteoarthritis Thumb

Treatments: Procedure: KeriFuse implant implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06151834

2023-A02072-43

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Patients

Experimental group

Description:

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

Treatment:

Procedure: KeriFuse implant implantation