NCT06151834

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Clinique Saint François, Nice, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Osteoarthritis Finger
• Osteoarthritis Thumb

Interventions

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

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-12-01
• Completion: 2026-09-01
• First posted: 2023-11-30
• Last updated: 2025-02-13

Locations

1 site across 1 country: France