Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KeriFuse implant implantation.
- Who it may be relevant to
- Registry conditions: Osteoarthritis Finger, Osteoarthritis Thumb. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device KF 23)
Overview
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
Interventions
- Procedure KeriFuse implant implantation
The surgery is an arthrodesis of finger or thumb (for patients with finger osteoarthritis) and involves implanting the KeriFuse implant.
Primary outcome measures
- Fusion time of bone in distal interphalangeal arthrodesis of the fingers [Time frame: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery]
Secondary outcome measures (4)
- Mid-term efficacy of arthrodesis in pain decrease [Time frame: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery]
- Evaluation of arthrosis degree [Time frame: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery]
- Patient satisfaction [Time frame: D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery]
- Evaluation of global hand function [Time frame: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Clinique Saint François — Nice
Identifiers
NCT: NCT06151834 · 2023-13-SFN