Post Market Clinical Follow-Up KeriFlex®

Last updated: August 6, 2024
Sponsor: Keri Medical SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Joint Injuries

Dermatomyositis (Connective Tissue Disease)

Treatment

KeriFlex®

Clinical Study ID

NCT06546345
2022-A01089-34
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (age ≥ 18 years)

  • Patients who are going to undergo arthroplasty of the metacarpophalangeal orproximal interphalangeal joint using a KeriFlex® implant in accordance with theinstructions for use and the labelling in force.

  • Patients with rheumatoid arthritis, osteoarthritis or post-traumatic osteoarthritis

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding women

  • Patients with an intellectual disability who cannot follow their surgeon'sinstructions

  • Patients with general surgery contraindications and particularly to the implantationof 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

Study Design

Total Participants: 86
Treatment Group(s): 1
Primary Treatment: KeriFlex®
Phase:
Study Start date:
November 14, 2023
Estimated Completion Date:
January 31, 2035

Connect with a study center

  • CHU Jean Minjoz

    Besançon Cedex, 25030
    France

    Active - Recruiting

  • Clinic Lille Sud

    Lesquin Cedex, 59813
    France

    Active - Recruiting

  • Institut aquitain de la main et du membre supérieur

    Pessac, 33600
    France

    Active - Recruiting

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