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NCT Number: NCT06151834

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

KeriFuse implant implantation

Procedure

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

Primary outcomes

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

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

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

Secondary outcomes

  1. Mid-term efficacy of arthrodesis in pain decrease

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

    Evaluation of pain with analogic visual scale

  2. Evaluation of arthrosis degree

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

    Evaluation fo arthrosis degree according to Kellgren-Lawrence scale

  3. Patient satisfaction

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

    Evaluation of patient satisfaction according to Likert scale

  4. Evaluation of global hand function

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

    Evaluation by the patient using functional score Quick DASH

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas DREANT, MD

CONTACT

[email protected]

+334 93 13 68 31

Sponsors and collaborators

Lead sponsor

Clinique Saint François, Nice, France

Other

Registry information

Official study title

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

Acronym: KF23

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 30, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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