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

Sponsor
Clinique Saint François, Nice, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06151834
Collaborator
(none)
50
Enrollment
1
Arm
33
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: KeriFuse implant implantation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device KF 23)
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

  1. Mid-term efficacy of arthrodesis in pain decrease [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 [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 [D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery]

    Evaluation of patient satisfaction according to Likert scale

  4. Evaluation of global hand function [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Clinique Saint François, Nice, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clinique Saint François, Nice, France
ClinicalTrials.gov Identifier:
NCT06151834
Other Study ID Numbers:
  • 2023-A02072-43
First Posted:
Nov 30, 2023
Last Update Posted:
Nov 30, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoarthritis

Study Results

No Results Posted as of Nov 30, 2023