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Recruiting NCT06546345

Post Market Clinical Follow-Up KeriFlex®

— Observational Rheumatoid Arthritis Degenerative Arthritis Traumatic Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KeriFlex®.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis, Degenerative Arthritis, Traumatic Arthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Device 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.

Primary outcome measures

  • Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • CHU Jean Minjoz — Besançon
  • Clinic Lille Sud — Lesquin
  • Institut aquitain de la main et du membre supérieur — Pessac

Identifiers

NCT: NCT06546345 · 2022-A01089-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗