Clinical trial NCT03991728: Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
Official title: International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Temporomandibular Joint Disorders
Keywords: Temporomandibular joint
TMJ replacement
Trauma
Ankylosis
Degenerative joint disease
Registry
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring alloplastic total TMJ replacement

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.

Detailed description: More in detail this registry has the following objectives:

* To describe clinical indications for TMJ replacement, and treatment patterns (including differences among regions if feasible)
* To describe the clinical evolution and outcomes of patients treated with a TMJ replacement
* To explore the relationship(s) between treatment, outcome(s) and quality of life (QoL).
* To identify predictive factors for favorable outcomes (pain reduction, range of motion (ROM), occlusal status, QoL) in patients treated with TMJ replacement.
* To describe the reasons of patients who refused TMJ replacements

Eligibility criteria: 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

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

Primary outcomes:
measure: The registry has no primary but several objectives.
timeFrame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary outcomes:
measure: Demographics
timeFrame: pre-operative
measure: Comorbidities
timeFrame: pre-operative
measure: Refusal of alloplastic total TMJ replacement surgery
timeFrame: pre-operative
measure: Clinical and functional outcomes - Mandibular movements
timeFrame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
measure: Clinical and functional outcomes - Occlusal status
timeFrame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
measure: Clinical and functional outcomes - Dentition
timeFrame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
measure: Clinical and functional outcomes - Helkimo Clinical dysfunction index
timeFrame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
measure: Patient Reported Outcomes - Pain numeric rating scale (NRS)
timeFrame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
measure: Patient Reported Outcomes - Jaw function NRS
timeFrame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
measure: Patient Reported Outcomes - Diet limitation NRS
timeFrame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
measure: Patient Reported Outcomes - EuroQoL five dimension (EQ-5D-5L)
timeFrame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months
measure: Patient Reported Outcomes - Oral Health Impact Profile (OHIP) - 14
timeFrame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months
measure: Anticipated treatment or condition-related adverse events (i.e. complications)
timeFrame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
measure: Survival
timeFrame: 10 days / 3 months / 6 months / 12 months / 24 months / 60 months
measure: Radiological parameters - Displacement of ramus component
timeFrame: pre-operative / 10 days / 12 months / 24 months
measure: Radiological parameters - Fracture of ramus component
timeFrame: pre-operative / 10 days / 12 months / 24 months
measure: Radiological parameters - Screw loosening
timeFrame: pre-operative / 10 days / 12 months / 24 months
measure: Radiological parameters - Resorption/ osteolysis of surrounding bone
timeFrame: pre-operative / 10 days / 12 months / 24 months
measure: Radiological parameters - Status of bone grafts if used (displaced/ resorbed/ healed)
timeFrame: pre-operative / 10 days / 12 months / 24 months
measure: Radiological parameters - Presence of ectopic bone
timeFrame: pre-operative / 10 days / 12 months / 24 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital BP - A Beneficência Portuguesa de São Paulo
city: Bogotá
country: Colombia
facility: Estetica Maxilofacial
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Hannover
country: Germany
facility: Hannover Medical School
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Mainz
country: Germany
facility: Klinikum der Johannes Gutenberg Universität Mainz
city: Munich
country: Germany
facility: Klinikum der LMU München
city: Bangalore
country: India
facility: Sri Shankara Cancer Hospital and Research Center
city: New Delhi
country: India
facility: All India Institute of Medical Sciences (AIIMS)
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Christchurch
country: New Zealand
facility: Waikato DHB
city: Lower Hutt
country: New Zealand
facility: Hutt Hospital
city: Lahore
country: Pakistan
facility: Mayo Hospital
city: Olsztyn
country: Poland
facility: Wojewódzki Specjalistyczny Szpital Dziecięcy
city: Moscow
country: Russian Federation
facility: National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation
city: Belgrade
country: Serbia
facility: Clinic for Maxillofacial Surgery, University of Belgrade
city: Durban
country: South Africa
facility: King Edward VIII Hospital
city: Madrid
country: Spain
facility: 12 de Octubre University Hospital
city: Falun
country: Sweden
facility: Falu Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Basel
country: Switzerland
facility: Universitätsspital Basel
Study officials:
affiliation: Oral and Maxillofacial surgery Uppsala University Hospital
name: Andreas Thor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oral and Maxillofacial surgery Uppsala University Hospital
name: Vinay V Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: