Post Market Clinical Follow-Up KeriFlex®

NCT06546345 | Recruiting

• 1 other identifier: 2022-A01089-34
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 3

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.

Conditions

Rheumatoid Arthritis; Degenerative Arthritis; Traumatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand

  Proportion of patients with a bMHQ score greater than the preoperative value at 6 months (postoperative).

  6 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any type of population requiring a surgical procedure covered by the device and presenting bone quality deemed satisfactory by the surgeon.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keri Medical SA: lead

Study Sites (3)

CHU Jean Minjoz

Besançon, 25030, France

RECRUITING

Clinic Lille Sud

Lesquin, 59813, France

RECRUITING

Institut aquitain de la main et du membre supérieur

Pessac, 33600, France

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

CAUX

CONTACT

058 255 01 30; clinic@kerimedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: November 14, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2035
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

FR (3)