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

ISRCTN	ISRCTN44212338
DOI	https://doi.org/10.1186/ISRCTN44212338
Secondary identifying numbers	N/A

Submission date: 28/12/2006
Registration date: 28/12/2006
Last edited: 12/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr G J Buijs
Scientific

University Medical Center Groningen (UMCG)
Department of Oral Surgery
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 361 0452
Email	g.j.buijs@kchir.umcg.nl

Study information

Study design	Randomised controlled parallel-group double-blinded multicentre trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Efficacy and safety aspects of biodegradable fixation systems: a randomised clinical trial
Study acronym	FixITT
Study objectives	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(s)	Medisch Ethische Toetsingscommissie Universitair Medisch Centrum Groningen, 01/05/2006, ref: 2006/035
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/2006
Completion date	01/10/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	230
Key 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
Key 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
Date of first enrolment	01/10/2006
Date of final enrolment	01/10/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Groningen (UMCG)

Groningen
9700 RB
Netherlands

Sponsor information

University Medical Center Groningen (UMCG) (The Netherlands)
Hospital/treatment centre

Department of Oral and Maxillofacial Surgery
Hanzeplein 1
Groningen
9713 GZ
Netherlands

Website	http://www.rug.nl/umcg/index?lang=en
"ROR"	https://ror.org/03cv38k47

Funders

Funder type

Industry

Stryker Nederland (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/03/2012	Yes	No
Results article	results	01/12/2013	Yes	No
Results article	results	20/07/2015	Yes	No
Results article	results	11/05/2017	Yes	No

Editorial Notes

12/05/2017: Publication reference added.