Efficacy and safety aspects of biodegradable fixation systems: a randomised clinical trial

niversity Medical Center Groningen (UMCG) (The Netherlands)0 sites230 target enrollmentDecember 28, 2006

Overview

No summary available.

Registry

who.int

Start Date

December 28, 2006

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional

Sponsor

niversity Medical Center Groningen (UMCG) (The Netherlands)

•1\. Patients scheduled for a solitair Le Fort I fractures, and/or
•2\. Patients scheduled for a solitair of multiple mandibula fracture(s), and/or
•3\. Patients scheduled for a solitair zygoma fracture, and/or
•4\. Patients scheduled for a Le Fort I osteotomy, and/or
•5\. Patients scheduled for a BSSO
•6\. Patients who signed the informed consent form

•1\. Severe chronically ill patients (i.e.. diabetes mellitus)
•2\. Patients by whom compromised bone healing has been established (i.e. osteoporosis)
•3\. Patients who are submerged through an infection
•4\. Patients who are pregnant
•5\. Patients who could not participate in a long follow\-up (reasons)
•6\. Patients who already have received maxillary surgery in the past (i.e,. schisis)
•7\. Patients who are diagnosed with a psychiatric disorder (diagnosed by a psychiatrist)
•8\. Patients who will not agree with a random assignment to one of the treatment groups or one of the methods of treatment used in the study
•9\. Patients younger than 18 years regarding patients treated for fractures and patients younger that 14 regarding patients treated for osteotomies