Post Market Clinical Follow-Up KeriFlex®

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06546345

Enrollment

Registered

2024-08-09

Start date

2023-11-14

Completion date

2035-01-31

Last updated

2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Arthritis, Rheumatoid Arthritis, Traumatic Arthritis

Brief 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. 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.

Interventions

DEVICEKeriFlex®

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand	6 months	Proportion of patients with a bMHQ score greater than the preoperative value at 6 months (postoperative).

Countries

France

Contacts

Primary ContactCAUX

clinic@kerimedical.com058 255 01 30

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026