Rheumatoid ArthritisNCT06546345
Post Market Clinical Follow-Up KeriFlex®
An observational study of Rheumatoid Arthritis and Degenerative Arthritis, run by Keri Medical SA at 3 sites in France.
Trial summary
The general objective of this study is to assess the performance and safety of the KeriFlex® silicone joint implant and its associated instruments, used in accordance with the labeling and instructions in force. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Degenerative Arthritis, Traumatic Arthritis
- What is being tested?
- KeriFlex®
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 3 sitesFrance
- Study dates
- 14 Nov 2023to Jan 2035
- Phase
- Observational
- 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
Study population: Any type of population requiring a surgical procedure covered by the device and presenting bone quality deemed satisfactory by the surgeon.
Who may be able to join
- Adult patients (age ≥ 18 years)
- Patients who are going to undergo arthroplasty of the metacarpophalangeal or proximal interphalangeal joint using a KeriFlex® implant in accordance with the instructions for use and the labelling in force.
- Patients with rheumatoid arthritis, osteoarthritis or post-traumatic osteoarthritis
Who cannot join
- Pregnant or breastfeeding women
- Patients with an intellectual disability who cannot follow their surgeon's instructions
- Patients with general surgery contraindications and particularly to the implantation of a KeriFlex® implant
- Patients with acute or chronic, local or systemic infections
- Metacarpal or phalanx destruction or poor bone quality preventing adequate fixation
- Muscle loss, alteration or vascular deficiency in the affected finger
- Patients with significant physical activity involving treated joint
- Children, young growing patients with open epiphyses
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHU Jean Minjoz
Besançon, 25030
OBERT
- Recruiting
Clinic Lille Sud
Lesquin, 59813
WAVREILLE
- Recruiting
Institut aquitain de la main et du membre supérieur
Pessac, 33600
ALET
About this study
Official title: Effectiveness and Safety of the Silicone Joint Implant KeriFlex® and of Its Associated Instruments in the Treatment of MCP and PIP Arthritis: Post Market Clinical Follow up
The general objective of this study is to assess the performance and safety of the KeriFlex® silicone joint implant and its associated instruments, used in accordance with the labeling and instructions in force.
The performance and safety of the KeriFlex® joint implant will be established in the short and long term with regard to the life cycle of the implant.
- Being tested
- KeriFlex®
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeriFlex®Device
The KeriFlex® finger joint prothesis MCP is designed to replace a damaged metacarpophalangeal (MCP) joint and the KeriFlex® finger joint prothesis PIP is designed to replace a damaged proximal interphalangeal (PIP) joint.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand
Proportion of patients with a bMHQ score greater than the preoperative value at 6 months (postoperative).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start14 Nov 2023
- Primary completionJul 2026 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keri Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546345
- Sponsor's protocol ID
- 2022-A01089-34
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of the Silicone Joint Implant KeriFlex® and of Its Associated Instruments in the Treatment of MCP and PIP Arthritis: Post Market Clinical Follow up
- ClinicalTrials.gov ID
- NCT06546345
- Acronym / sponsor ID
- 2022-A01089-34
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Keri Medical SAIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 9 Aug 2024 (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.
The general objective of this study is to assess the performance and safety of the KeriFlex® silicone joint implant and its associated instruments, used in accordance with the labeling and instructions in force.
The performance and safety of the KeriFlex® joint implant will be established in the short and long term with regard to the life cycle of the implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any type of population requiring a surgical procedure covered by the device and presenting bone quality deemed satisfactory by the surgeon.
Key inclusion criteria (3 listed)
- Adult patients (age ≥ 18 years)
- Patients who are going to undergo arthroplasty of the metacarpophalangeal or proximal interphalangeal joint using a KeriFlex® implant in accordance with the instructions for use and the labelling in force.
- Patients with rheumatoid arthritis, osteoarthritis or post-traumatic osteoarthritis
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding women
- Patients with an intellectual disability who cannot follow their surgeon's instructions
- Patients with general surgery contraindications and particularly to the implantation of a KeriFlex® implant
- Patients with acute or chronic, local or systemic infections
- Metacarpal or phalanx destruction or poor bone quality preventing adequate fixation
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 |
|---|---|---|
| KeriFlex®The KeriFlex® finger joint prothesis MCP is designed to replace a damaged metacarpophalangeal (MCP) joint and the KeriFlex® finger joint prothesis PIP is designed to replace a damaged proximal interphalangeal (PIP) joint. | Device | – |
Primary outcome
Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand
Time frame: 6 months
Proportion of patients with a bMHQ score greater than the preoperative value at 6 months (postoperative).
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 11 Sep 2025.
Related trials for Rheumatoid Arthritis
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Active, not recruitingObservational study
Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries
Rheumatoid Arthritis, Ankylosing Spondylitis
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren's Syndrome
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
Not yet recruitingPhase 2
A Clinical Trial of MK-8690 in Participants With Rheumatoid Arthritis (MK-8690-004)
Rheumatoid Arthritis
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Degenerative Arthritis, run by Keri Medical SA at 3 sites 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 3 inclusion and 8 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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 CAUX (058 255 01 30 ext. +41, clinic@kerimedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand (time frame: 6 months). 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 11 Sep 2025.