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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
15/10/2024

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.
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
Timepoint [1] 0 0
pre-operative
Secondary outcome [2] 0 0
Comorbidities
Timepoint [2] 0 0
pre-operative
Secondary outcome [3] 0 0
Refusal of alloplastic total TMJ replacement surgery
Timepoint [3] 0 0
pre-operative
Secondary outcome [4] 0 0
Clinical and functional outcomes - Mandibular movements
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
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
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
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)
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
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
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)
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
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)
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
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
Timepoint [15] 0 0
pre-operative / 10 days / 12 months / 24 months
Secondary outcome [16] 0 0
Radiological parameters - Fracture of ramus component
Timepoint [16] 0 0
pre-operative / 10 days / 12 months / 24 months
Secondary outcome [17] 0 0
Radiological parameters - Screw loosening
Timepoint [17] 0 0
pre-operative / 10 days / 12 months / 24 months
Secondary outcome [18] 0 0
Radiological parameters - Resorption/ osteolysis of surrounding bone
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)
Timepoint [19] 0 0
pre-operative / 10 days / 12 months / 24 months
Secondary outcome [20] 0 0
Radiological parameters - Presence of ectopic bone
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
Munich
Country [7] 0 0
India
State/province [7] 0 0
Bangalore
Country [8] 0 0
India
State/province [8] 0 0
New Delhi
Country [9] 0 0
Netherlands
State/province [9] 0 0
Rotterdam
Country [10] 0 0
New Zealand
State/province [10] 0 0
Christchurch
Country [11] 0 0
New Zealand
State/province [11] 0 0
Lower Hutt
Country [12] 0 0
Pakistan
State/province [12] 0 0
Lahore
Country [13] 0 0
Poland
State/province [13] 0 0
Olsztyn
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Moscow
Country [15] 0 0
Serbia
State/province [15] 0 0
Belgrade
Country [16] 0 0
South Africa
State/province [16] 0 0
Durban
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Sweden
State/province [18] 0 0
Falun
Country [19] 0 0
Sweden
State/province [19] 0 0
Lund
Country [20] 0 0
Sweden
State/province [20] 0 0
Stockholm
Country [21] 0 0
Sweden
State/province [21] 0 0
Uppsala
Country [22] 0 0
Switzerland
State/province [22] 0 0
Basel

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03991728
Trial related presentations / publications
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
Fax 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
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03991728