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

Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device KF 23)

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis Thumb; Osteoarthritis Finger
• Intervention / Treatment: Procedure: KeriFuse implant implantation

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas DREANT, MD; Phone Number: +334 93 13 68 31; Email: nicolas.dreant@sfr.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Clinique Saint François
    • Contact: Valentine Lammens; Phone Number: +334.93.13.65.00; Email: vlammens@vivalto-sante.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients; Patients older than 18 years-old, with a surgical indication of interphalangeal arthrodesis of finger	Procedure: KeriFuse implant implantation; The surgery is an arthrodesis of finger or thumb (for patients with finger osteoarthritis) and involves implanting the KeriFuse implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion time of bone in distal interphalangeal arthrodesis of the fingers	Fusion time of bone (in weeks) will be measure by X-ray,	day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mid-term efficacy of arthrodesis in pain decrease	Evaluation of pain with analogic visual scale	day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery
Evaluation of arthrosis degree	Evaluation fo arthrosis degree according to Kellgren-Lawrence scale	day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery
Patient satisfaction	Evaluation of patient satisfaction according to Likert scale	D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery
Evaluation of global hand function	Evaluation by the patient using functional score Quick DASH	day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery

Collaborators and Investigators

• Sponsor: Clinique Saint François, Nice, France

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 2023-A02072-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No