Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
ConditionTemporomandibular Joint Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAO Innovation Translation Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years and or older
Patients requiring alloplastic total TMJ replacement
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)
Disqualifiers
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
Trial population
Patients requiring alloplastic total TMJ replacement
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Alloplastic total TMJ replacement
Trial outcomes
Primary outcomes
1
The registry has no primary but several objectives.
due to the study design, no primary objective has been defined and therefore no primary outcome measure either
Time frame
from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)Secondary outcomes
1
Demographics
Year of birth Gender Smoking
Time frame
pre-operative2
Comorbidities
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
Time frame
pre-operative3
Refusal of alloplastic total TMJ replacement surgery
For patients who require alloplastic total TMJ replacement but refuse surgery, the reason(s) for refusal will be collected.
Time frame
pre-operative4
Clinical and functional outcomes - Mandibular movements
Interincisial opening/maximal opening Lateral movements Protrusive movement
Time frame
from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov