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

Osteoarthritis Thumb Clinical Trial

— KF23  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151834
• Other study ID #: 2023-A02072-43
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: February 2024
• Source: Clinique Saint François, Nice, France
• Contact: Nicolas DREANT, MD
• Phone: +334 93 13 68 31
• Email: nicolas.dreant[@]sfr.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Finger
• Osteoarthritis Thumb

Intervention

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

Locations

Country	Name	City	State
France	Clinique Saint François	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Saint François, Nice, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Patient satisfaction	Evaluation of patient satisfaction according to Likert scale	D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery
Secondary	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