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RecruitingNCT06151834KF23Updated Jul 10, 2026

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

An interventional study of KeriFuse implant implantation in Osteoarthritis Finger and Osteoarthritis Thumb, sponsored by Clinique Saint François, Nice, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Clinique Saint François, Nice, France · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

Read the 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
02

Conditions studied

  • Osteoarthritis Finger
  • Osteoarthritis Thumb
03

In context

Lead sponsor

Clinique Saint François, Nice, France is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Patients

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

    Procedure: KeriFuse implant implantation

Interventions

  • ProcedureKeriFuse implant implantation

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

06

What researchers measure

Primary outcomes

  1. Fusion time of bone in distal interphalangeal arthrodesis of the fingers

    Fusion time of bone (in weeks) will be measure by X-ray,

    Time frame: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery

Secondary outcomes

  1. Mid-term efficacy of arthrodesis in pain decrease

    Evaluation of pain with analogic visual scale

    Time frame: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery

  2. Evaluation of arthrosis degree

    Evaluation fo arthrosis degree according to Kellgren-Lawrence scale

    Time frame: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery

  3. Patient satisfaction

    Evaluation of patient satisfaction according to Likert scale

    Time frame: D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery

  4. Evaluation of global hand function

    Evaluation by the patient using functional score Quick DASH

    Time frame: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery

07

Study locations

1 of 1 sites recruiting
  • Clinique Saint François
    Nice, 06000, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06151834
Lead sponsor
Clinique Saint François, Nice, France
Responsible party
Sponsor
First posted
Nov 30, 2023
Start date
Dec 1, 2023
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Jul 10, 2026

Study contacts

Nicolas DREANT, MD
Contact
nicolas.dreant@sfr.fr
+334 93 13 68 31

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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