Clinique Saint François
Nice, 06000, France
Location status: Recruiting
NCT Number: NCT06151834
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Nice, 06000, France
Location status: Recruiting
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The surgery is an arthrodesis of finger or thumb (for patients with finger osteoarthritis) and involves implanting the KeriFuse implant.
Time frame: 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,
Time frame: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery
Evaluation of pain with analogic visual scale
Time frame: 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
Time frame: D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery
Evaluation of patient satisfaction according to Likert scale
Time frame: 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
Contact information is provided by the study sponsor or research team.
Clinique Saint François, Nice, France
Other
Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device KF 23)
Acronym: KF23
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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