Clinical trial NCT06151834: Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device
Official title: Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device KF 23)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis Finger
Osteoarthritis Thumb
Lead sponsor: Clinique Saint François, Nice, France
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Fusion time of bone in distal interphalangeal arthrodesis of the fingers
timeFrame: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery
Secondary outcomes:
measure: Mid-term efficacy of arthrodesis in pain decrease
timeFrame: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery
measure: Evaluation of arthrosis degree
timeFrame: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery
measure: Patient satisfaction
timeFrame: D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery
measure: Evaluation of global hand function
timeFrame: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery
Other outcomes:
Locations:
city: Nice
country: France
facility: Clinique Saint François
Study officials:
References: