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Trial registered on ANZCTR


Registration number
ACTRN12618000323224
Ethics application status
Approved
Date submitted
19/02/2018
Date registered
5/03/2018
Date last updated
23/04/2019
Date data sharing statement initially provided
23/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
TOS: TrimphDent for Orthognathic Surgery. A clinical investigation comparing the bone growth stimulation capability of "TrimphDent" (investigational product) and autologous bone grafting (use of patient's own bone) to in adults undergoing surgery to correct a defect of the jaw.
Scientific title
TOS: TrimphDent for Orthognathic Surgery. A comparator-controlled, four (4) arm prospective clinical investigation to evaluate the optimal configuration of TrimphDent required to produce a clinical outcome similar to or better than that of autologous bone grafting. For adult patients indicated for orthographic surgery of the mandible or maxilla to correct an oral-maxillofacial defect.
Secondary ID [1] 293303 0
None
Universal Trial Number (UTN)
U1111-1206-5890
Trial acronym
TOS: TrimphDent for Orthognathic Surgery
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Dentofacial Skeletal Anomalies 305857 0
Condition category
Condition code
Surgery 305063 305063 0 0
Other surgery
Musculoskeletal 305875 305875 0 0
Other muscular and skeletal disorders
Oral and Gastrointestinal 305876 305876 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gold-standard state of the art orthognathic jaw surgery involves application of autologous bone graft to a surgically cut bone, to stimulate natural bone growth and healing. TrimphDent is a synthetic bone graft substitute formulated from a synthetic polymer (PNPHO - 140 mg per 1 ml of sterile water) chemically crosslinked with a synthetic peptide Thymosin B4 (30 mg per 1 ml of PNPHO solution).
The approximate duration of the intervention is 2 hours.
TrimphDent will be administered by an oral and maxillofacial or orthognathic surgeon.

Clinical investigation participants will be randomised into one of four treatment groups;
Treatment 1 - Trimph Dent including Thymosin ß4 (investigational)
Treatment 2 - Trimph Dent including Thymosin ß4 and 0.15 mg/ml BMP-2 (investigational)
Treatment 3 - Trimph Dent including Thymosin ß4 and 0.30 mg/ml BMP-2 (investigational)
Treatment 4 - Standard of care autologous bone grafting
Intervention code [1] 299856 0
Treatment: Devices
Comparator / control treatment
The comparator / control group will undergo standard of care autologous bone grafting treatment
Control group
Active

Outcomes
Primary outcome [1] 304230 0
Identify the optimal configuration of TrimphDent required to product a clinical outcome similar to or better than that of autologous bone grafting. Assessed via amount of new bone growth (speed of new bone regeneration) per imaging e.g. CT.
Timepoint [1] 304230 0
At each follow-up visit i..e. at 21 days, 3 months, 6 months and 12 months, post application of TrimphDent or autologous bone grafting.
Primary outcome [2] 304992 0
Identify the optimal configuration of TrimphDent required to product a clinical outcome similar to or better than that of autologous bone grafting. Assessed via quality of new bone formation (bone density) per standard computer-guided software.
Timepoint [2] 304992 0
At each follow-up visit i..e. at 21 days, 3 months, 6 months and 12 months, post application of TrimphDent or autologous bone grafting.
Secondary outcome [1] 341318 0
Safety assessed via;
1. Blood loss during application of treatment plan per qualitative physician assessment.
2. Wound appearance per qualitatively physician assessment.
3. Pain at the treatment plan application site per qualitatively assessment of participant reported adverse events .
4. Swelling at the treatment plan application site per qualitatively physician visual inspection.
5. Infection rate at the treatment plan application site per physician visual inspection.
Timepoint [1] 341318 0
1. At time of treatment plan application only.
2. At each follow-up visit i..e. at 21 days, 3 months, 6 months and 12 months, post application of TrimphDent or autologous bone grafting.
3. At each follow-up visit i..e. at 21 days, 3 months, 6 months and 12 months, post application of TrimphDent or autologous bone grafting.
4. At each follow-up visit i..e. at 21 days, 3 months, 6 months and 12 months, post application of TrimphDent or autologous bone grafting.
5. At each follow-up visit i..e. at 21 days, 3 months, 6 months and 12 months, post application of TrimphDent or autologous bone grafting.
Secondary outcome [2] 343610 0
Usability assessed via quantitative measurement of total theatre time i.e. time between treatment plan start and end time.
Timepoint [2] 343610 0
At time of treatment plan application only.

Eligibility
Key inclusion criteria
Participants 18 years of age or greater.
Participants with treatment plans including any osteotomy width between 8 mm and 12 mm.
Participants willing to give written informed consent and willing to participate in and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with any osteotomy width less than 8 mm or greater than 12 mm.
Patients with chronic inflammation, out of range blood markers:
o Erythrocyte sedimentation rate (ESR) above 22 mm for male and 29 mm for female candidates.
o C-reactive proteins (CRP) above 5 mg/L.
• Patients with low liver function, as indicated by:
o ALT and AST level > 1.5 times the upper limit of normal (ULN).
o Alkaline phosphatase above 140 IU/L.
o INR below 0.8 or above 1.3.
o Bilirubin above 1.2 mg/dL.
• Patients with low kidney function, as indicated by:
o Serum creatinine above 1.4 for both male and female (the norm for male is 1.4 and for female is 1.2).
o Glomerular filtration rate (GFR) of below 60 mL/min/1.73m2).
• Patients <18 years of age.
• Pregnant or lactating women, or women of childbearing potential who are not willing to avoid becoming pregnant during the study.
• Patients who are concurrently enrolled in another clinical study, or have received an investigational new drug within the past four (4) weeks.
• Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
• Patients unwilling or unlikely, in the Principal Investigator’s opinion, to comply with the study follow-up.
• Patients with an American Society of Anaesthesiologists (ASA) physical status classification of ASA 2 or greater.
• Patients who are undergoing or are to undergo an immunosuppressive therapy.
• Patients with active cancer.

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)
The PI will determine if a subject is eligible for inclusion in the clinical investigation and if so, obtain required informed consent.
The PI will advise the sponsor that a clinical trial participant is available for inclusion in the clinical investigation.
The sponsor will randomise the clinical trial participant to the applicable treatment plan using a sealed opaque envelope concealment process.
The PI will be informed whether the participant has been assigned to a standard of care autologous bone grafting or investigational product treatment plan.
If the participant is randomised to an investigational product treatment plan, the PI will remain blinded to which investigational treatment plan has been assigned.
It is not possible to conceal the autologous bone grafting treatment arm of the clinical investigation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order for the allocation of subjects will be generated using computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The objective of the study is to identify the optimal configuration of TrimphDent required to produce a clinical outcome comparable to the standard of care. The sample size is not statistically derived. There is no statistical plan for this trial. Pending results of this investigation, further investigations, with statistically derived sample sizes and statistical plans, may be performed.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
15/03/2018
Actual
Date of last participant enrolment
Anticipated
1/03/2019
Actual
Date of last data collection
Anticipated
29/04/2019
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10045 0
East Sydney Private Hospital - Woolloomooloo
Recruitment hospital [2] 10046 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [3] 10047 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 18441 0
2031 - Randwick
Recruitment postcode(s) [2] 21563 0
2011 - Woolloomooloo

Funding & Sponsors
Funding source category [1] 298725 0
Commercial sector/Industry
Name [1] 298725 0
Trimph Technology Pty Ltd
Country [1] 298725 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Trimph Technology Pty Ltd
Address
Trimph Technology Pty Ltd
34 Ralph Street Alexandria New South Wales 2015 Australia
Country
Australia
Secondary sponsor category [1] 297970 0
None
Name [1] 297970 0
Address [1] 297970 0
Country [1] 297970 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298974 0
St Vincents Hospital Melbourne
Ethics committee address [1] 298974 0
41 Victoria Parade, Fitzroy VIC 3065
Ethics committee country [1] 298974 0
Australia
Date submitted for ethics approval [1] 298974 0
21/09/2017
Approval date [1] 298974 0
03/11/2017
Ethics approval number [1] 298974 0
HREC 190/17

Summary
Brief summary
This is a double-blind, randomised, comparator-controlled, four (4) arm, prospective investigation.
The primary objective of this clinical investigation is to identify the optimal configuration of TrimphDent required to produce a clinical outcome similar to or better than that of autologous bone graft. The secondary objective of the clinical investigation is to evaluate the safety and usability of TrimphDent.
Trial website
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 78854 0
Dr Peter Tsakiris
Address 78854 0
Oral and Maxillofacial Surgery
56 Arthur Street, Randwick NSW 2031 Australia
Country 78854 0
Australia
Phone 78854 0
+61 (0)2 9340 4376
Fax 78854 0
Email 78854 0
[email protected]
Contact person for public queries
Name 78855 0
Ali Fathi
Address 78855 0
Trimph Technology Pty Ltd
34 Ralph Street Alexandria New South Wales 2015 Australia
Country 78855 0
Australia
Phone 78855 0
+61 4 1372 1939
Fax 78855 0
Email 78855 0
[email protected]
Contact person for scientific queries
Name 78856 0
Ali Fathi
Address 78856 0
Trimph Technology Pty Ltd
34 Ralph Street Alexandria New South Wales 2015 Australia
Country 78856 0
Australia
Phone 78856 0
+61 4 1372 1939
Fax 78856 0
Email 78856 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial was withdrawn prior to enrolment of any participants.


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.