Post Market Clinical Follow-Up KeriFlex®
Recruiting · NCT06546345 · Observational (researchers observe without assigning treatment) · Lead sponsor: Keri Medical SA
View the official record on ClinicalTrials.gov →Interventions studied
KeriFlex®
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
6 locations listed.
- CHU Jean Minjoz - Besançon, France
- CHU Jean Minjoz - Besançon, France
- Clinic Lille Sud - Lesquin, France
- Clinic Lille Sud - Lesquin, France
- Institut aquitain de la main et du membre supérieur - Pessac, France
- Institut aquitain de la main et du membre supérieur - Pessac, France