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

NCT06151834 | Recruiting

• 1 other identifier: 2023-A02072-43
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Finger; Osteoarthritis Thumb

Outcome Measures

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,

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

Secondary Outcomes (4)

• 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 arthrosis degree

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

• Patient satisfaction

  D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery

• Evaluation of global hand function

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

Study Arms (1)

Patients

EXPERIMENTAL

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

Procedure: KeriFuse implant implantation

Interventions

KeriFuse implant implantation PROCEDURE

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinique Saint François, Nice, France: lead

Study Sites (1)

Clinique Saint François

Nice, 06000, France

RECRUITING

Central Study Contacts

Nicolas DREANT, MD

CONTACT

+334 93 13 68 31; nicolas.dreant@sfr.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 30, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)