Osteoarthritis FingerKF23NCT06151834
Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device
A study testing KeriFuse implant implantation in people with Osteoarthritis Finger and Osteoarthritis Thumb, run by Clinique Saint François, Nice, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Finger, Osteoarthritis Thumb
- What is being tested?
- KeriFuse implant implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2023to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients with osteoarthritis of finger for an interphalangeal arthrodesis with KeriFuse implant
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Saint François
Nice, 06000
Valentine Lammens, +334.93.13.65.00, vlammens@vivalto-sante.com
About this study
Official title: Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device KF 23)
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.
Read the 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
- Conditions
- Osteoarthritis Finger, Osteoarthritis Thumb
- Being tested
- KeriFuse implant implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeriFuse implant implantationProcedure or surgery
The surgery is an arthrodesis of finger or thumb (for patients with finger osteoarthritis) and involves implanting the KeriFuse implant.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients older than 18 years-old, with a surgical indication of interphalangeal arthrodesis of finger Receives: Procedure: KeriFuse implant implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion time of bone in distal interphalangeal arthrodesis of the fingers
Fusion time of bone (in weeks) will be measure by X-ray,
Measured: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery
Secondary outcomes (4)
Mid-term efficacy of arthrodesis in pain decrease
Evaluation of pain with analogic visual scale
Measured: 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
Measured: 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
Measured: D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery
Evaluation of global hand function
Evaluation by the patient using functional score Quick DASH
Measured: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis FingerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint François, Nice, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151834
- Sponsor's protocol ID
- 2023-13-SFN
- Acronym
- KF23
- Status last verified
- Jul 2026
- First submitted
- 14 Nov 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device KF 23)
- ClinicalTrials.gov ID
- NCT06151834
- Acronym / sponsor ID
- KF23 / 2023-13-SFN
- Conditions
- Osteoarthritis Finger, Osteoarthritis Thumb
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Clinique Saint François, Nice, FranceUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: KeriFuse implant implantationPatients older than 18 years-old, with a surgical indication of interphalangeal arthrodesis of finger |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients with osteoarthritis of finger for an interphalangeal arthrodesis with KeriFuse implant
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KeriFuse implant implantationThe surgery is an arthrodesis of finger or thumb (for patients with finger osteoarthritis) and involves implanting the KeriFuse implant. | Procedure or surgery | Patients |
Primary outcome
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
Fusion time of bone (in weeks) will be measure by X-ray,
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KeriFuse implant implantation in people with Osteoarthritis Finger and Osteoarthritis Thumb, run by Clinique Saint François, Nice, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas DREANT, MD (+334 93 13 68 31, nicolas.dreant@sfr.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.