A randomised prospective trial comparing bioabsorbable versus titanium plates in the treatment of mandibular and zygomatic fractures
| ISRCTN | ISRCTN63274027 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63274027 |
| Secondary identifying numbers | N0265154611 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 26/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr K Webster
Scientific
Scientific
Maxillofacial Surgery
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
Study information
| Study design | Prospective single-blind randomised single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised prospective trial comparing bioabsorbable versus titanium plates in the treatment of mandibular and zygomatic fractures |
| Study objectives | Mandibular and zygomatic fractures are conventually fixed by open reduction and internal fixation using titanium plates and screws. Between 18-35% of these plates are subsequently removed due to complications such as loosening. Bioabsorbable plates are now available as an alternative to metal plates. The potential advantage of using resorbable plates is that the reoperation rate to remove titanium plates that develop complications would be greatly reduced. The Inion(R) bioabsorbable material comprises the polymers L-polylactic acid, D/L-polylactic acid, trimethylene carbonate and polyglycolic acid. The material degrades by hydrolysis into carbon dioxide and water, in a similar fashion to "dissolving" sutures. The degradation profile provides initial stability to the facial bone and then progressive. Although bioabsorbable plates have been used in facial fractures there is no prospective data to confirm that they are equivalent to titanium plates. A prospective comparison of the two systems would define whether bioabsorbable plates have a lower complication rate and whether a reduction in reoperation rate can be achieved. The Null hypothesis to be answered is: there is no difference in the re-operation rate in mandibular and zygomatic fracture repair between titanium and Inion(R) bioabsorbable plates. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health |
| Intervention | All patients presenting to the maxillofacial trauma service at University Hospital Birmingham with mandibular and maxillary fractures will be randomised to two treatment arms: 1. Conventional treatment with ORIF using titanium miniplates 2. ORIF using bioabsorbable plates Invasive procedures and investigations: no change in pre-operative workup will be required Duration of study: outpatient review at 1 week, 6 weeks, six months and 12 months End points/outcomes: a comparison of complication rates in each group. Expected complications: infection, loosening of plates and screws, plate fracture, plate exposure (in mouth), malunion, non-union of fracture |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The rate of removal of resorbable vs non resorbable plates in facial fractures |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/2005 |
| Completion date | 25/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Healthy adult volunteers 2. Traumatic mandibular or zygomatic fractures |
| Key exclusion criteria | 1. Overt infection 2. Pregnancy 3. Under 16 4. Pathological fractures, prisoner, malignancy |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 25/01/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
University Hospital Birmingham NHS Trust (UK), NHS R&D Support Funding
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 |
Editorial Notes
26/10/2015: no publications found on PubMed.
