Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Saint François, Nice, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eligible patients with osteoarthritis of finger for an interphalangeal arthrodesis with KeriFuse implant
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
KeriFuse implant implantation
Procedure/SurgeryThe surgery is an arthrodesis of finger or thumb (for patients with finger osteoarthritis) and involves implanting the KeriFuse implant.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: PatientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fusion time of bone in distal interphalangeal arthrodesis of the fingers
Fusion time of bone (in weeks) will be measure by X-ray,
Time frame
day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgerySecondary outcomes
1
Mid-term efficacy of arthrodesis in pain decrease
Evaluation of pain with analogic visual scale
Time frame
day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery2
Evaluation of arthrosis degree
Evaluation fo arthrosis degree according to Kellgren-Lawrence scale
Time frame
day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery3
Patient satisfaction
Evaluation of patient satisfaction according to Likert scale
Time frame
D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery4
Evaluation of global hand function
Evaluation by the patient using functional score Quick DASH
Time frame
day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgerySponsors and contacts
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Source ClinicalTrials.gov