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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03991728
Registration number
NCT03991728
Ethics application status
Date submitted
12/06/2019
Date registered
19/06/2019
Date last updated
14/02/2024
Titles & IDs
Public title
Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
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Scientific title
International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements
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Secondary ID [1]
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TMJ Replacement
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Temporomandibular Joint Disorders
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The registry has no primary but several objectives.
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Assessment method [1]
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due to the study design, no primary objective has been defined and therefore no primary outcome measure either
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Timepoint [1]
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from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
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Secondary outcome [1]
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Demographics
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Assessment method [1]
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Year of birth Gender Smoking
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Timepoint [1]
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pre-operative
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Secondary outcome [2]
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Comorbidities
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Assessment method [2]
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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
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Timepoint [2]
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pre-operative
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Secondary outcome [3]
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Refusal of alloplastic total TMJ replacement surgery
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Assessment method [3]
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For patients who require alloplastic total TMJ replacement but refuse surgery, the reason(s) for refusal will be collected.
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Timepoint [3]
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pre-operative
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Secondary outcome [4]
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Clinical and functional outcomes - Mandibular movements
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Assessment method [4]
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Interincisial opening/maximal opening Lateral movements Protrusive movement
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Timepoint [4]
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from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
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Secondary outcome [5]
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Clinical and functional outcomes - Occlusal status
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Assessment method [5]
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Occlusion will be assessed according to Angle's classification:
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Timepoint [5]
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from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
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Secondary outcome [6]
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Clinical and functional outcomes - Dentition
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Assessment method [6]
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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 .
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Timepoint [6]
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from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
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Secondary outcome [7]
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Clinical and functional outcomes - Helkimo Clinical dysfunction index
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Assessment method [7]
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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.
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Timepoint [7]
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from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
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Secondary outcome [8]
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Patient Reported Outcomes - Pain numeric rating scale (NRS)
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Assessment method [8]
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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.
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Timepoint [8]
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from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
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Secondary outcome [9]
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Patient Reported Outcomes - Jaw function NRS
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Assessment method [9]
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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.
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Timepoint [9]
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from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
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Secondary outcome [10]
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Patient Reported Outcomes - Diet limitation NRS
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Assessment method [10]
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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.
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Timepoint [10]
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from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
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Secondary outcome [11]
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Patient Reported Outcomes - EuroQoL five dimension (EQ-5D-5L)
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Assessment method [11]
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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.
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Timepoint [11]
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from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months
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Secondary outcome [12]
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Patient Reported Outcomes - Oral Health Impact Profile (OHIP) - 14
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Assessment method [12]
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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.
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Timepoint [12]
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from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months
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Secondary outcome [13]
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Anticipated treatment or condition-related adverse events (i.e. complications)
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Assessment method [13]
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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
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Timepoint [13]
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from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
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Secondary outcome [14]
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Survival
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Assessment method [14]
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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.
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Timepoint [14]
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10 days / 3 months / 6 months / 12 months / 24 months / 60 months
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Secondary outcome [15]
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Radiological parameters - Displacement of ramus component
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Assessment method [15]
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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:
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Timepoint [15]
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pre-operative / 10 days / 12 months / 24 months
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Secondary outcome [16]
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Radiological parameters - Fracture of ramus component
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Assessment method [16]
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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
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Timepoint [16]
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pre-operative / 10 days / 12 months / 24 months
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Secondary outcome [17]
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Radiological parameters - Screw loosening
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Assessment method [17]
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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
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Timepoint [17]
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pre-operative / 10 days / 12 months / 24 months
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Secondary outcome [18]
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Radiological parameters - Resorption/ osteolysis of surrounding bone
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Assessment method [18]
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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
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Timepoint [18]
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pre-operative / 10 days / 12 months / 24 months
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Secondary outcome [19]
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Radiological parameters - Status of bone grafts if used (displaced/ resorbed/ healed)
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Assessment method [19]
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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
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Timepoint [19]
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pre-operative / 10 days / 12 months / 24 months
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Secondary outcome [20]
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Radiological parameters - Presence of ectopic bone
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Assessment method [20]
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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
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Timepoint [20]
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pre-operative / 10 days / 12 months / 24 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/10/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2027
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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São Paulo
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Country [2]
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Colombia
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State/province [2]
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Bogotá
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Country [3]
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Germany
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State/province [3]
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Hannover
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Country [4]
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Germany
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State/province [4]
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Leipzig
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Country [5]
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Germany
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State/province [5]
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Munich
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Country [6]
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India
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State/province [6]
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Bangalore
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Country [7]
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India
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State/province [7]
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New Delhi
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Country [8]
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Netherlands
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State/province [8]
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Rotterdam
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Country [9]
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New Zealand
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State/province [9]
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Christchurch
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Country [10]
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New Zealand
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State/province [10]
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Lower Hutt
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Country [11]
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Pakistan
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State/province [11]
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Lahore
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Country [12]
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Poland
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State/province [12]
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Olsztyn
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Country [13]
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Russian Federation
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State/province [13]
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Moscow
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Country [14]
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Serbia
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State/province [14]
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Belgrade
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Country [15]
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South Africa
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State/province [15]
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Durban
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Country [16]
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Spain
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State/province [16]
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Madrid
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Country [17]
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Sweden
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State/province [17]
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Falun
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Country [18]
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Sweden
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State/province [18]
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Lund
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Country [19]
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Sweden
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State/province [19]
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Stockholm
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Country [20]
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Sweden
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State/province [20]
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Uppsala
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Country [21]
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Switzerland
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State/province [21]
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Basel
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Funding & Sponsors
Primary sponsor type
Other
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Name
AO Clinical Investigation and Publishing Documentation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Prospective data will be collected in approximately 200 patients treated with an TMJ
replacement. Patients will be followed up according to the standard (routine) for up to 5
years after the treatment. Data collection will include underlying disease, treatment
details, functional and patient reported outcomes (PRO)s and anticipated or procedure-related
adverse events (i.e. complications).
This registry is designed to be able to assess the number of patients who refuse alloplastic
total TMJ replacement. Therefore, the participating sites are asked to register all cases of
refused TMJ replacements too.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03991728
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Andreas Thor, MD
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Address
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Oral and Maxillofacial surgery Uppsala University Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Alix Frischknecht
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Address
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Country
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Phone
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+41 79 606 41 48
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03991728
Download to PDF