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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Osteoarthritis Finger, Osteoarthritis Thumb

Intervention / Treatment
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* Procedure: KeriFuse implant implantation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Patients older than 18 years-old, with a surgical indication of interphalangeal arthrodesis of finger | Procedure: KeriFuse implant implantation<br>* The surgery is an arthrodesis of finger or thumb (for patients with finger osteoarthritis) and involves implanting the KeriFuse implant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mid-term efficacy of arthrodesis in pain decrease | Evaluation of pain with analogic visual scale | day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery | 
| Evaluation of arthrosis degree | Evaluation fo arthrosis degree according to Kellgren-Lawrence scale | day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery | 
| Patient satisfaction | Evaluation of patient satisfaction according to Likert scale | D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery | 
| Evaluation of global hand function | Evaluation by the patient using functional score Quick DASH | day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery |