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Efficacy and Safety Aspects of Biodegradable Fixation Systems: a Randomized Clinical Trial.


- candidate number2253
- NTR NumberNTR772
- ISRCTNISRCTN44212338
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR19-sep-2006
- Secondary IDsN/A 
- Public TitleEfficacy and Safety Aspects of Biodegradable Fixation Systems: a Randomized Clinical Trial.
- Scientific TitleEfficacy and Safety Aspects of Biodegradable Fixation Systems: a Randomized Clinical Trial.
- ACRONYMFixITT
- hypothesisThe performance of the Inion biodegradable osteofixation system is inferior compared to a titanium system regarding the treatment of zygoma, Le Fort I fractures, Le Fort I osteotomies, mandibula fractures en bi-lateral sagittal split osteotomies of the maxillofacial skeleton by healthy patients with regard to bone healing, stability and complications like, infections, plate dehiscenceís, hypersensitivity and palpability?
- Healt Condition(s) or Problem(s) studiedMaxillofacial trauma
- Inclusion criteria1. 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, and/or;
6. patients who signed the informed consent form.
- Exclusion criteria1. severe chronically ill patients (i.e.. diabetis mellites);
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 an at random assignment to one of the treatment groups or one of the methods of treatment used in the study;
9. patients younger than 18 year regarding patients treated for fractures and patients younger that 14 regarding patients treated for osteotomies.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-okt-2006
- planned closingdate1-okt-2008
- Target number of participants230
- InterventionsFixing bone segments in the maxillofacial skeleton with titanium or biodegradable fixation devices.
- Primary outcomeBone healing is the primary outcome measure. The definition of bone healing is:
healing of the bone segments after 8 weeks without clinical and radiological signs of disturbed bone healing. Bone healing related complications are not allowed during this period.
- Secondary outcome1. inflammatory reaction present (redness, swelling, sensitivity, warmth, function impairment, fistula or pus drainage), assessment visual and manually;
2. seriousness inflammatory reaction (mild, serious), assessment visual and manually;
3. palpability, assessment manually;
4. dehiscence, assessment visual;
5. occlusion, assessment visual. bone formation (screw holes, fracture crevice);
6. pain, evaluated by a Visual Analogue Scale (VAS);
7. cold/warm sensitivity;
8. mandibular function, evaluated by a Mandibular Function Impairment Questionnaire (MFIQ).
9. direct costs within the de health care;
10. direct costs outside the health care;
11. indirect costs outside the health care.
12. antibiotic use;
13. analgesic use;
14. re-operation required;
15. reasons re-operations (plate/screw exposition, plat/screw fracture, loosening of plates and screws, inadequate bone healing, inadequate reduction, infection or other reasons).
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESprof. dr. G.M. Raghoebar
- CONTACT for SCIENTIFIC QUERIESdrs. G.J. Buijs
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Oral and Maxillofacial Surgery
- Funding
(Source(s) of Monetary or Material Support)
Stryker Nederland
- PublicationsN/A
- Brief summaryThe aim of this multi-center randomized clinical trial is to investigate the efficacy and safety aspects of the Inion biodegradable osteofixation system in comparison to a titanium system for the treatment of maxillofacial traumata and orthognatic anomalies in the maxillofacial skeleton.
The research population consists of patients who are scheduled for treatment of
1. zygoma fractures,
2. Le Fort I fractures,
3. Le Fort I osteotomies,
4. mandibular fractures and
5. Bi-lateral Sagittal Split OsteotomiŽs (BSSO).
The patients (blinded for treatment group) will be assigned at random to a titanium and a degradable group. Bone fixation by patients in the biodegradable group will be done with the Inion degradable fixation system. The used titanium system will be a conventional system. The two treatment modalities (biodegradable versus titanium) will be compared at non-inferiority level. The reason for this is that bone segments fixed with biodegradable plates and screws must heal as good as bone segments fixed with titanium plates and screws.
Bone healing is the primary outcome measure. The definition of bone healing is:
healing of the bone segments after 8 weeks without any clinical and radiological signs of disturbed bone healing. The secondary outcome measures contain the following aspects: inflammatory reaction present, seriousness inflammatory reaction, palpability, dehiscence, occlusion, bone formation, pain, cold/warm sensitivity, mandibular function, and costs.
- Main changes (audit trail)
- RECORD19-sep-2006 - 29-dec-2006


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