JaW PrinT
Research type
Research Study
Full title
Jaw reconstruction with printed or flexed titanium and free tissue transfer.
IRAS ID
241919
Contact name
Mark Williams
Contact email
Sponsor organisation
University of South Wales
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Summary of Research
JaW PrinT is a prospective observational study, designed to evaluate the clinical effectiveness and economics of two routinely performed surgical approaches/pathways for mandibular (lower jaw) reconstruction. Mandibular reconstruction is required immediately following removal of a diseased segment of the lower jaw (e.g. for cancer, radiotherapy damage or benign tumours). There are two techniques in routine use, both involve the use of a segment of the fibula bone (from the lower leg) to replace the removed piece of diseased jaw bone, along with a customised titanium plate and screws to hold the bones in place until the new jaw heals together. The difference between the two pathways/techniques relates to the way in which the plate has been fabricated. One plate is first manufactured as a solid titanium plate and then flexed and customised to the shape of the new jaw, prior to the surgery. The other plate is manufactured by a different technique; from powdered titanium which is then melted into the planned jaw shape. The two different plates are standard/routine treatment at the Abertawe Bro Morgannwg University Health Board (and at other Oral and Maxillofacial centres worldwide) and are entirely transferrable, with identical indications for clinical use. The two require slight differences in surgical technique (specifically the sequence in which screw holes are drilled and screws placed), with no clear benefit or disadvantage of either approach. It is the difference in the overall surgical treatment pathways that we would like to evaluate: i.e. the implications upon placement of the fibula bone through either surgical technique. Primarily we aim to evaluate the accuracy of the actual jaw bone reconstruction in comparison to the planned reconstruction as well as secondary 'quality of life' measures, using data that is in the main, available from routine clinical tests performed before and after surgery.Summary of Results
There was no significance in duration of surgery overall and associated duration of hospital stay for printed versus pre-flexed patient-specific plates. User (surgeon) ratings for ease of technique were favourable and comparable between groups. With regards to reconstructive accuracy, printed titanium plates appear to provide a superior match of actual neomandibular morphology to the computer-aided-design (CAD) surgical plan, where the plan and the actual reconstructed jaw three-dimensional accuracy measurements (mean absolute distance) correate (align) closely in the printed group but do not in the pre-bent plate groiup. A simpler measure of reconstructive accuracy by using the the width of the newly reconstructed jaw (intercondylar distance) was significantly more accurate in the printed plate group than the pre-bent plate group. Some quality of life measures early (a few weeks) after the surgery suggest a superior functional-social (appearance-related) outcome in the printed plate group but there was no significant difference in the longer-term (1 year after surgery).In summary, this feasibility study demonstrates a significant difference in accuracy of the jaw reconstruction between customised 3D-printed plates for major jaw reconstruction in comparison to hand-bent customised plates. A larger follow-on study will clarify if there is a longer-term benefit on functional-social quality of life.
REC name
Wales REC 2
REC reference
18/WA/0031
Date of REC Opinion
24 Jan 2018
REC opinion
Favourable Opinion