A randomised control trial to assess efficacy of finite element analysis (FEA) modelled personalised jaw exercise program using RestorabiteTM following jaw reconstruction for head and neck cancer

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The purpose of this research is to test the effectiveness of using a computer simulation to personalise the force recommendations for jaw stretching and exercise program and compare this to the usual jaw stretching and exercise program. We will do this by using finite element analysis that uses information from CT scans to predict what is the best amount and place to apply pressure to stretch the mouth after undergoing jaw surgery. Once we have the recommendations we can deliver the pressure using a device called RestorabiteTM. RestorabiteTM is a class I medical device that has been approved in Australia by the Therapeutic Goods Administration (TGA) ARTG ID 407358. Who is it for? You may be eligible to join this study if you are aged 18 years and older, have head and neck cancer and will undergo a segmental mandibulectomy and reconstruction at COBL Study Details: This is a randomised controlled trial. Each participant is put into a group by chance (random). In this study, the groups are either control (Low force) or intervention (Personalised force recommendation). Intervention: 1.Maxium Incisal Opening (MIO) will be measured. 2. Standard of care virtual surgical planning (VSP) will be performed prior to surgery and undergo a segmental mandibulectomy and reconstructive surgery. 3. FEA using the VSP and standard of care post-operative CT scans will be conducted to optimise the postoperative exercise program by providing force and location targets (i.e., the ideal amount and location to apply force to the jaw). 4. A jaw-stretching device (RestorabiteTM) will be used to deliver the exercise program starting at 2 weeks after surgery. 5. The exercise program will continue for 10 weeks under the supervision of a speech pathologist. 6. After the 10 week exercise program, participants will be advised by their speech pathologist whether they will require a maintenance program. This will be recommended for any participant with a MIO<35mm. Participants will conduct their maintenance program independently and follow up appointments to monitor MIO, exercise adherence and adverse events. The control group will be patients undergoing the same procedure but excludes Step 3 (FEA to model personalised jaw exercise). This control group constitutes standard care at Chris O’Brien Lifehouse for patients undergoing segmental mandibulectomy and reconstruction. For all participants from both groups, you will have an assessment of your mouth opening and quality of life questionnaire (10 minutes). This will be carried out before surgery, then at 2 and 12 weeks, 6, 12, 18, 24 months post-surgery. This research is testing if using the personalised force recommendations might improve your mouth opening over time after the operation compared to our usual low pressure. By personalising exercises, we hope to prevent or minimise the onset of restricted mouth opening (trismus) after jaw reconstruction surgery. Participation in this clinical trial is voluntary

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