Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints

Status Recruiting

Clinical Trial Summary

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06151834
Study type	Interventional
Source	Clinique Saint François, Nice, France
Contact	Nicolas DREANT, MD
Phone	+334 93 13 68 31
Email	nicolas.dreant@sfr.fr
Status	Recruiting
Phase	N/A
Start date	December 1, 2023
Completion date	September 1, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms