Condition category
Musculoskeletal Diseases
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
21/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 below 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

http://www.rug.nl/umcg/index?lang=en

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

1. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22269272
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24130219
3. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26192813

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes