Efficacy and safety aspects of biodegradable fixation systems: a randomised clinical trial
| ISRCTN | ISRCTN44212338 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44212338 |
| Protocol serial number | N/A |
| Sponsor | University Medical Center Groningen (UMCG) (The Netherlands) |
| Funder | Stryker Nederland (The Netherlands) |
- 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
Scientific
University Medical Center Groningen (UMCG)
Department of Oral Surgery
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 361 0452 |
|---|---|
| g.j.buijs@kchir.umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled parallel-group double-blinded multicentre trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant 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(s) | 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. |
| Key secondary outcome measure(s) | 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) |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
9700 RB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/05/2017: Publication reference added.
