Post Market Clinical Follow-Up KeriFlex®

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Degenerative Arthritis Immune System Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Skin and Connective Tissue Diseases Traumatic Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Jean Minjoz, Besançon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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).

Study contacts

Contact information is provided by the study sponsor or research team.

CAUX

CONTACT

[email protected]

058 255 01 30 ext. +41

Sponsors and collaborators

Lead sponsor

Keri Medical SA

Industry

Registry information

Official study 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

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2035
First posted: Aug 9, 2024
Registry last updated: Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting