Osteoarthritis Finger, Osteoarthritis Thumb
Conditions
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
Interventions
PROCEDUREKeriFuse implant implantation
The surgery is an arthrodesis of finger or thumb (for patients with finger osteoarthritis) and involves implanting the KeriFuse implant.
Sponsors
Clinique Saint François, Nice, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
France
Contacts
CONTACTNicolas DREANT, MD
Outcome results
None listed