Contact information
Type
Scientific
Primary contact
Dr G J Buijs
ORCID ID
Contact details
University Medical Center Groningen (UMCG)
Department of Oral Surgery
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 361 0452
g.j.buijs@kchir.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy and safety aspects of biodegradable fixation systems: a randomised clinical trial
Acronym
FixITT
Study hypothesis
The 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 and Bi-lateral Sagittal Split Osteotomies (BSSO) of the maxillofacial skeleton by healthy patients with regard to bone healing, stability and complications like, infections, plate dehiscence, hypersensitivity and palpability.
Ethics approval
Medisch Ethische Toetsingscommissie Universitair Medisch Centrum Groningen, 01/05/2006, ref: 2006/035
Study design
Randomised controlled parallel-group double-blinded multicentre trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Maxillofacial trauma and orthognathic anomalies in the maxillofacial skeleton
Intervention
Fixing bone segments in the maxillofacial skeleton with titanium or biodegradable fixation devices.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Bone healing is the primary outcome measure. The definition of bone healing is: healing of the bone segments after eight weeks without clinical and radiological signs of disturbed bone healing.
Bone healing related complications are not allowed during this period.
Secondary outcome measures
1. 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
6. Bone formation (screw holes, fracture crevice)
7. Pain, evaluated by a Visual Analogue Scale (VAS)
8. Cold/warm sensitivity
9. Mandibular function, evaluated by a Mandibular Function Impairment Questionnaire (MFIQ)
10. Direct costs within the health care
11. Direct costs outside the health care
12. Indirect costs outside the health care
13. Antibiotic use
14. Analgesic use
15. Re-operation required
16. Reasons re-operations (plate/screw exposition, plat/screw fracture, loosening of plates and screws, inadequate bone healing, inadequate reduction, infection or other reasons)
Overall trial start date
01/10/2006
Overall trial end date
01/10/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
230
Participant 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
Recruitment start date
01/10/2006
Recruitment end date
01/10/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
University Medical Center Groningen (UMCG) (The Netherlands)
Sponsor details
Department of Oral and Maxillofacial Surgery
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Stryker Nederland (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22269272
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24130219
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26192813
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28493922
Publication citations
-
Results
Buijs GJ, van Bakelen NB, Jansma J, de Visscher JG, Hoppenreijs TJ, Bergsma JE, Stegenga B, Bos RR, A randomized clinical trial of biodegradable and titanium fixation systems in maxillofacial surgery., J. Dent. Res., 2012, 91, 3, 299-304, doi: 10.1177/0022034511434353.
-
Results
van Bakelen NB, Buijs GJ, Jansma J, de Visscher JG, Hoppenreijs TJ, Bergsma JE, Stegenga B, Bos RR, Comparison of biodegradable and titanium fixation systems in maxillofacial surgery: a two-year multi-center randomized controlled trial., J. Dent. Res., 2013, 92, 12, 1100-1105, doi: 10.1177/0022034513508953.
-
Results
van Bakelen NB, Vermeulen KM, Buijs GJ, Jansma J, de Visscher JG, Hoppenreijs TJ, Bergsma JE, Stegenga B, Bos RR, Cost-Effectiveness of a Biodegradable Compared to a Titanium Fixation System in Maxillofacial Surgery: A Multicenter Randomized Controlled Trial, PLoS One, 2015 , 10, 7, e0130330, doi: 10.1371/journal.pone.0130330.