Actively Recruiting
Effectiveness and Safety of the Silicone Joint Implant KeriFlex4 and Its Instruments for MCP and PIP Arthritis: Post Market Clinical Follow-Up
Led by Keri Medical SA · Updated on 2025-09-11
86
Participants Needed
3
Research Sites
443 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance and safety of the KeriFlex4 silicone joint implant and its associated instruments in adults with rheumatoid arthritis, osteoarthritis, or post-traumatic osteoarthritis affecting the hand joints. The study aims to establish both short- and long-term safety and how well the implant improves hand function over time. Participants will undergo arthroplasty surgery using the KeriFlex4 implant to replace damaged metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The device is designed specifically for these finger joints and is used according to official instructions and labeling. This is an observational study with no placebo or comparison groups. During the study, researchers will assess the effectiveness of the implant in improving hand function six months after surgery. Safety and performance will be monitored throughout the implant's life cycle. Participants will be followed up long term to observe the implant's durability and any related health outcomes. The study may last several years, with the final completion estimated by 2035.
CONDITIONS
Brief Title
Post Market Clinical Follow-Up KeriFlex®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (age �3E= 18 years)
- Patients scheduled for arthroplasty of the metacarpophalangeal or proximal interphalangeal joint using the KeriFlex4 implant following official instructions and labeling
- Patients diagnosed with rheumatoid arthritis, osteoarthritis, or post-traumatic osteoarthritis
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients with intellectual disabilities unable to follow surgeon's instructions
- Patients with contraindications to general surgery or KeriFlex4 implant implantation
- Patients with acute or chronic local or systemic infections
- Patients with metacarpal or phalanx destruction or poor bone quality preventing proper fixation
- Patients with muscle loss, alteration, or vascular deficiency in the affected finger
- Patients with significant physical activity involving the treated joint
- Children or young growing patients with open epiphyses
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo implantation of the KeriFlex® finger joint prosthesis designed to replace damaged finger joints.
1 visit (in-person)
Duration - 6 months
Participants are monitored for effectiveness and safety of the KeriFlex® implant, including functional hand assessments.
Multiple visits over 6 months
Trial Site Locations
Total: 3 locations
1
CHU Jean Minjoz
Besançon, France, 25030
Actively Recruiting
2
Clinic Lille Sud
Lesquin, France, 59813
Actively Recruiting
3
Institut aquitain de la main et du membre supérieur
Pessac, France, 33600
Actively Recruiting
Research Team
C
CAUX
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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