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

Completed

• Conditions: Maxillofacial trauma and orthognathic anomalies in the maxillofacial skeleton; Musculoskeletal Diseases; Maxillofacial and oral trauma

• Registration Number: ISRCTN44212338
• Lead Sponsor: niversity Medical Center Groningen (UMCG) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-28
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 230

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified