Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device
- Conditions
- Osteoarthritis ThumbOsteoarthritis Finger
- Interventions
- Procedure: KeriFuse implant implantation
- Registration Number
- NCT06151834
- Lead Sponsor
- Clinique Saint François, Nice, France
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Eligible patients with osteoarthritis of finger for an interphalangeal arthrodesis with KeriFuse implant
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients KeriFuse implant implantation Patients older than 18 years-old, with a surgical indication of interphalangeal arthrodesis of finger
- Primary Outcome Measures
Name Time Method 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
Name Time Method Patient satisfaction D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery Evaluation of patient satisfaction according to Likert scale
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
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
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
Trial Locations
- Locations (1)
Clinique Saint François
🇫🇷Nice, France