Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
86 participants
OBSERVATIONAL
2023-11-14
2035-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Keri Medical SA
INDUSTRY
Responsible Party
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Locations
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CHU Jean Minjoz
Besançon, , France
Clinic Lille Sud
Lesquin, , France
Institut aquitain de la main et du membre supérieur
Pessac, , France
Countries
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Central Contacts
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Facility Contacts
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OBERT
Role: primary
WAVREILLE
Role: primary
ALET
Role: primary
Other Identifiers
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2022-A01089-34
Identifier Type: -
Identifier Source: org_study_id
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