Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265154611
Study information
Scientific title
A randomised prospective trial comparing bioabsorbable versus titanium plates in the treatment of mandibular and zygomatic fractures
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Prospective single-blind randomised single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled 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
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
Phase
Drug names
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 trial start date
01/03/2005
Overall trial end date
25/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy adult volunteers
2. Traumatic mandibular or zygomatic fractures
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Overt infection
2. Pregnancy
3. Under 16
4. Pathological fractures, prisoner, malignancy
Recruitment start date
01/03/2005
Recruitment end date
25/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK), NHS R&D Support Funding
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
Basic results (scientific)
Publication list