Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625001093471p
Ethics application status
Submitted, not yet approved
Date submitted
9/09/2025
Date registered
8/10/2025
Date last updated
8/10/2025
Date data sharing statement initially provided
8/10/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 315344 0
None
Universal Trial Number (UTN)
Trial acronym
FEA-Restorabite Program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 338827 0
Trismus 338828 0
Condition category
Condition code
Cancer 335121 335121 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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. A computer simulation called finite element analysis uses information from computed tomography (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.

Intervention (Personalised jaw exercise program):
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.

FEA modelling will be performed in Abaqus (Dassault Systemes) to determine the safe loading conditions (i.e., location and force) based on the VSP or stand of care postoperative CT scans. FEA modelling will prescribe a personalised jaw exercise program.

Jaw exercise program with RestorabiteTM will commence under the supervision of a speech pathologist (through inpatient consultation) at two weeks after surgery for both the intervention and control groups

All participants will commence the jaw exercise program at 10 newtons (N) force. They complete 10 stretches of 1 minute duration daily jaw exercise comprises of opening and closing the mouth against resistance, facilitated by a weekly speech pathology appointment for total of 10 weeks.

The reviews with the speech pathologist are anticipated to take about 15 minutes and can be completed in person or over telehealth. At four weeks post-surgery at a routine follow up with the surgeon, the speech pathologist will use personalised force recommendation to modify your exercise program, which will continue for another six weeks.

Intervention code [1] 331953 0
Treatment: Devices
Intervention code [2] 331954 0
Rehabilitation
Comparator / control treatment
Control group (Standard of care jaw exercise program):
The control group will be patients undergoing the same procedure as the intervention group but excludes Step 3 (FEA to model personalised jaw exercise). This control group constitutes of the standard care at Chris O'Brien Lifehouse for patients undergoing segmental mandibulectomy and reconstruction.
Control group
Active

Outcomes
Primary outcome [1] 342758 0
Assess the efficacy of FEA-modelled personalised jaw stretching exercises using RestorabiteTM
Timepoint [1] 342758 0
2 weeks postoperative; after completion of the 10-week jaw exercise program [Primary], and at 6, 12, 18 and 24 months.
Secondary outcome [1] 452020 0
Health related quality of life (HRQOL)
Timepoint [1] 452020 0
2 weeks postoperative; after completion of the 10-week jaw exercise program, and at 6, 12, 18 and 24 months.

Eligibility
Key inclusion criteria
- All cases will be discussed at weekly Multidisciplinary Team (MDT) meeting and deemed appropriate for the protocol within that setting
- Planned for a segmental mandibulectomy and osseous free flap reconstruction
- Cleared by their surgical team for involvement in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to provide informed consent
- Aged less than 18 years old

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised in a 1:1 allocation. This study will not be blinded. The randomisation will be generated immediately following participant’s enrolment after the signing of the consent form by the study team. A randomisation list will be created by an independent biostatistician and that the investigators enrolling patients will not have access to this list. A statistician will draw up a randomisation schedule and place it into the REDCap project for the study team to conduct randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Using an effect size of 5 mm and a standard deviation of 7 mm, 90% power and using a one-sided alpha = 0.05, a sample size of 51 participants per arm (total of 102 participants) will be required after allowing for 20% drop out, which may be higher than usual given that this is a cancer population. Longitudinal outcomes (MIO, GTQ) will be analysed using generalised estimating equations (GEE), adjusting for tumour or defect location, category, adjuvant radiation, age, and exercise adherence

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/10/2025
Actual
Date of last participant enrolment
Anticipated
30/10/2028
Actual
Date of last data collection
Anticipated
30/10/2030
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319921 0
Hospital
Name [1] 319921 0
Chris O'Brien Lifehouse
Country [1] 319921 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
Country
Australia
Secondary sponsor category [1] 322460 0
None
Name [1] 322460 0
Address [1] 322460 0
Country [1] 322460 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318468 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 318468 0
Ethics committee country [1] 318468 0
Australia
Date submitted for ethics approval [1] 318468 0
14/08/2025
Approval date [1] 318468 0
Ethics approval number [1] 318468 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 144290 0
Prof Jonathan Clark
Address 144290 0
Chris O'Brien Lifehouse; 119-143 Missenden Rd, Camperdown, NSW, 2050
Country 144290 0
Australia
Phone 144290 0
+61 02 8514 0268
Fax 144290 0
Email 144290 0
[email protected]
Contact person for public queries
Name 144291 0
Masako Dunn
Address 144291 0
Chris O'Brien Lifehouse; 119-143 Missenden Rd, Camperdown, NSW, 2050
Country 144291 0
Australia
Phone 144291 0
+61 02 8514 0411
Fax 144291 0
Email 144291 0
[email protected]
Contact person for scientific queries
Name 144292 0
Jonathan Clark
Address 144292 0
Chris O'Brien Lifehouse; 119-143 Missenden Rd, Camperdown, NSW, 2050
Country 144292 0
Australia
Phone 144292 0
+61 02 8514 0268
Fax 144292 0
Email 144292 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.