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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03991728




Registration number
NCT03991728
Ethics application status
Date submitted
12/06/2019
Date registered
19/06/2019
Date last updated
25/03/2025

Titles & IDs
Public title
Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
Scientific title
International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements
Secondary ID [1] 0 0
TMJ Replacement
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporomandibular Joint Disorders 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Alloplastic total TMJ replacement - All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics. The registry does not dictate any specific treatment.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The registry has no primary but several objectives.
Assessment method [1] 0 0
due to the study design, no primary objective has been defined and therefore no primary outcome measure either
Timepoint [1] 0 0
from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary outcome [1] 0 0
Demographics
Assessment method [1] 0 0
Year of birth Gender Smoking
Timepoint [1] 0 0
pre-operative
Secondary outcome [2] 0 0
Comorbidities
Assessment method [2] 0 0
Concomitant diseases will be assessed using the Charlson Comorbidity Index (CCI). This score assesses the comorbidity level by considering both the number and severity of pre-defined comorbid conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality rates
Timepoint [2] 0 0
pre-operative
Secondary outcome [3] 0 0
Refusal of alloplastic total TMJ replacement surgery
Assessment method [3] 0 0
For patients who require alloplastic total TMJ replacement but refuse surgery, the reason(s) for refusal will be collected.
Timepoint [3] 0 0
pre-operative
Secondary outcome [4] 0 0
Clinical and functional outcomes - Mandibular movements
Assessment method [4] 0 0
Interincisial opening/maximal opening Lateral movements Protrusive movement
Timepoint [4] 0 0
from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary outcome [5] 0 0
Clinical and functional outcomes - Occlusal status
Assessment method [5] 0 0
Occlusion will be assessed according to Angle's classification:
Timepoint [5] 0 0
from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary outcome [6] 0 0
Clinical and functional outcomes - Dentition
Assessment method [6] 0 0
Dental status will be recorded as: * Edentulous * Complete dentition * Partial dentition In case of partial dentition, missing teeth will be recorded individually using the Fédération Dentaire Internationale (FDI) tooth numbering formula .
Timepoint [6] 0 0
from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary outcome [7] 0 0
Clinical and functional outcomes - Helkimo Clinical dysfunction index
Assessment method [7] 0 0
The dysfunction of the mandible will be evaluated by means of the Helkimo index. The Helkimo index is based on the assessment of five different symptoms.
Timepoint [7] 0 0
from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary outcome [8] 0 0
Patient Reported Outcomes - Pain numeric rating scale (NRS)
Assessment method [8] 0 0
The Pain NRS is an 11-point scale where the end points are the extremes of no pain (0 points), to worst imaginable pain (10 points). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain. Will be assessed independently for each site.
Timepoint [8] 0 0
from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary outcome [9] 0 0
Patient Reported Outcomes - Jaw function NRS
Assessment method [9] 0 0
The jaw function NRS is an 11-point scale where the end points are the extremes of normal jaw movement (0 points), to no jaw movement (10 points). It measures subjective jaw function.
Timepoint [9] 0 0
from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary outcome [10] 0 0
Patient Reported Outcomes - Diet limitation NRS
Assessment method [10] 0 0
The diet limitation NRS is an 11-point scale where the end points are the extremes of no restrictions (0 points), to liquids only (10 points). It measures subjective diet limitations.
Timepoint [10] 0 0
from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary outcome [11] 0 0
Patient Reported Outcomes - EuroQoL five dimension (EQ-5D-5L)
Assessment method [11] 0 0
The EQ-5D-5L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Timepoint [11] 0 0
from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months
Secondary outcome [12] 0 0
Patient Reported Outcomes - Oral Health Impact Profile (OHIP) - 14
Assessment method [12] 0 0
The OHIP is concerned with impairment and three functional status dimensions (social, psychological and physical) which represent four of the seven quality of life dimensions proposed by Patrick and Bergner. Hence, it excludes perceptions of satisfaction with oral health, changes in oral health, prognosis or self-reported diagnoses. Furthermore, the OHIP aims to capture impacts that are related to oral conditions in general, rather than impacts that may be attributed to specific oral disorders or syndromes. All impacts in the OHIP are conceptualized as adverse outcomes, and therefore the instrument does not measure any positive aspects of oral health. The OHIP consists of 14 items evaluated using a 5-point Likert from "Never" to "Very often " in which higher scores indicated worse outcomes. It has validated translations to Swedish, Spanish, German, Hindi and further more.
Timepoint [12] 0 0
from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months
Secondary outcome [13] 0 0
Anticipated treatment or condition-related adverse events (i.e. complications)
Assessment method [13] 0 0
In this registry, only anticipated condition, treatment-, or implant-related adverse events (i.e. complications) will be documented in the electronic case report form (eCRF) from the time of consent onwards. In the context of the registry, these events are considered as events of scientific interest, i.e. events that can clearly be connected to the treatment(s) or the medical condition under investigation. These events do not require immediate reporting unless they occur at a higher frequency and/or severity to that cited in the literature
Timepoint [13] 0 0
from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary outcome [14] 0 0
Survival
Assessment method [14] 0 0
Follow up (FU) visits will be scheduled and performed according to the local standard of care and at each scheduled visit the patient's survival will be documented. In case a patient misses a scheduled visit, it will be assessed if the patient is still alive, which can be done via phone call.
Timepoint [14] 0 0
10 days / 3 months / 6 months / 12 months / 24 months / 60 months
Secondary outcome [15] 0 0
Radiological parameters - Displacement of ramus component
Assessment method [15] 0 0
All images (preferably computed tomography (CT) / cone beam (CB) CT scan) taken as part of the standard (routine) will be collected and 'displacement of ramus component' evaluated by local investigator:
Timepoint [15] 0 0
pre-operative / 10 days / 12 months / 24 months
Secondary outcome [16] 0 0
Radiological parameters - Fracture of ramus component
Assessment method [16] 0 0
All images (preferably computed tomography (CT) / cone beam (CB) CT scan) taken as part of the standard (routine) will be collected and evaluated by local investigator if a 'fracture of the ramus component' occurred
Timepoint [16] 0 0
pre-operative / 10 days / 12 months / 24 months
Secondary outcome [17] 0 0
Radiological parameters - Screw loosening
Assessment method [17] 0 0
All images (preferably computed tomography (CT) / cone beam (CB) CT scan) taken as part of the standard (routine) will be collected and evaluated by local investigator if 'screw loosening' occurred
Timepoint [17] 0 0
pre-operative / 10 days / 12 months / 24 months
Secondary outcome [18] 0 0
Radiological parameters - Resorption/ osteolysis of surrounding bone
Assessment method [18] 0 0
All images (preferably computed tomography (CT) / cone beam (CB) CT scan) taken as part of the standard (routine) will be collected and 'resorption/ osteolysis of surrounding bone' evaluated by local investigator
Timepoint [18] 0 0
pre-operative / 10 days / 12 months / 24 months
Secondary outcome [19] 0 0
Radiological parameters - Status of bone grafts if used (displaced/ resorbed/ healed)
Assessment method [19] 0 0
All images (preferably computed tomography (CT) / cone beam (CB) CT scan) taken as part of the standard (routine) will be collected and 'status of bone grafts if used (displaced/ resorbed/ healed)' evaluated by local investigator
Timepoint [19] 0 0
pre-operative / 10 days / 12 months / 24 months
Secondary outcome [20] 0 0
Radiological parameters - Presence of ectopic bone
Assessment method [20] 0 0
All images (preferably computed tomography (CT) / cone beam (CB) CT scan) taken as part of the standard (routine) will be collected and 'presence of ectopic bone' evaluated by local investigator
Timepoint [20] 0 0
pre-operative / 10 days / 12 months / 24 months

Eligibility
Key inclusion criteria
* Age 18 years and or older
* Patients requiring alloplastic total TMJ replacement
* Informed consent obtained, i.e.:

* Ability to understand the content of the patient information/informed consent form (ICF)
* Willingness and ability to participate in the registry according to the Registry Plan (RP)
* Signed and dated ethics committee (EC) / Institutional review board (IRB) approved written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or women planning to conceive within the study period
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2033
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
São Paulo
Country [2] 0 0
Colombia
State/province [2] 0 0
Bogotá
Country [3] 0 0
Denmark
State/province [3] 0 0
Copenhagen
Country [4] 0 0
Germany
State/province [4] 0 0
Hannover
Country [5] 0 0
Germany
State/province [5] 0 0
Leipzig
Country [6] 0 0
Germany
State/province [6] 0 0
Mainz
Country [7] 0 0
Germany
State/province [7] 0 0
Munich
Country [8] 0 0
India
State/province [8] 0 0
Bangalore
Country [9] 0 0
India
State/province [9] 0 0
New Delhi
Country [10] 0 0
Netherlands
State/province [10] 0 0
Rotterdam
Country [11] 0 0
New Zealand
State/province [11] 0 0
Christchurch
Country [12] 0 0
New Zealand
State/province [12] 0 0
Lower Hutt
Country [13] 0 0
Pakistan
State/province [13] 0 0
Lahore
Country [14] 0 0
Poland
State/province [14] 0 0
Olsztyn
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Moscow
Country [16] 0 0
Serbia
State/province [16] 0 0
Belgrade
Country [17] 0 0
South Africa
State/province [17] 0 0
Durban
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Sweden
State/province [19] 0 0
Falun
Country [20] 0 0
Sweden
State/province [20] 0 0
Lund
Country [21] 0 0
Sweden
State/province [21] 0 0
Stockholm
Country [22] 0 0
Sweden
State/province [22] 0 0
Uppsala
Country [23] 0 0
Switzerland
State/province [23] 0 0
Basel

Funding & Sponsors
Primary sponsor type
Other
Name
AO Innovation Translation Center
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Thor, MD
Address 0 0
Oral and Maxillofacial surgery Uppsala University Hospital
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Viola Grünenfelder
Address 0 0
Country 0 0
Phone 0 0
+41 79 696 33 97
Email 0 0
viola.gruenenfelder@aofoundation.org
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03991728