Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

Temporomandibular Joint Disorders Clinical Trial

Official title:

International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03991728
• Other study ID #: TMJ Replacement
• Status: Recruiting
• Start date: October 15, 2019
• Est. completion date: December 2027

Study information

• Verified date: February 2024
• Source: AO Innovation Translation Center
• Contact: Alix Frischknecht
• Phone: +41 79 606 41 48
• Email: alix.frischknecht[@]aofoundation.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Locations

Country	Name	City	State
Brazil	Hospital BP - A Beneficência Portuguesa de São Paulo	São Paulo
Colombia	Estetica Maxilofacial	Bogotá
Germany	Hannover Medical School	Hannover
Germany	University Hospital Leipzig	Leipzig
Germany	Klinikum der LMU München	Munich
India	Sri Shankara Cancer Hospital and Research Center	Bangalore
India	All India Institute of Medical Sciences (AIIMS)	New Delhi
Netherlands	Erasmus Medisch Centrum	Rotterdam
New Zealand	Waikato DHB	Christchurch
New Zealand	Hutt Hospital	Lower Hutt
Pakistan	Mayo Hospital	Lahore
Poland	Wojewódzki Specjalistyczny Szpital Dzieciecy	Olsztyn
Russian Federation	National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation	Moscow
Serbia	Clinic for Maxillofacial Surgery, University of Belgrade	Belgrade
South Africa	King Edward VIII Hospital	Durban
Spain	12 de Octubre University Hospital	Madrid
Sweden	Falu Hospital	Falun
Sweden	Skåne University Hospital	Lund
Sweden	Karolinska University Hospital	Stockholm
Sweden	Uppsala University Hospital	Uppsala
Switzerland	Universitätsspital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

Brazil,  Colombia,  Germany,  India,  Netherlands,  New Zealand,  Pakistan,  Poland,  Russian Federation,  Serbia,  South Africa,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary	Demographics	Year of birth Gender Smoking	pre-operative
Secondary	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	pre-operative
Secondary	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.	pre-operative
Secondary	Clinical and functional outcomes - Mandibular movements	Interincisial opening/maximal opening Lateral movements Protrusive movement	from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary	Clinical and functional outcomes - Occlusal status	Occlusion will be assessed according to Angle's classification:	from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary	Clinical and functional outcomes - Dentition	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 .	from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary	Clinical and functional outcomes - Helkimo Clinical dysfunction index	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.	from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary	Patient Reported Outcomes - Pain numeric rating scale (NRS)	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.	from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary	Patient Reported Outcomes - Jaw function NRS	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.	from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary	Patient Reported Outcomes - Diet limitation NRS	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.	from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary	Patient Reported Outcomes - EuroQoL five dimension (EQ-5D-5L)	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.	from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months
Secondary	Patient Reported Outcomes - Oral Health Impact Profile (OHIP) - 14	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.	from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months
Secondary	Anticipated treatment or condition-related adverse events (i.e. complications)	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	from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
Secondary	Survival	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.	10 days / 3 months / 6 months / 12 months / 24 months / 60 months
Secondary	Radiological parameters - Displacement of ramus component	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:	pre-operative / 10 days / 12 months / 24 months
Secondary	Radiological parameters - Fracture of ramus component	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	pre-operative / 10 days / 12 months / 24 months
Secondary	Radiological parameters - Screw loosening	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	pre-operative / 10 days / 12 months / 24 months
Secondary	Radiological parameters - Resorption/ osteolysis of surrounding bone	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	pre-operative / 10 days / 12 months / 24 months
Secondary	Radiological parameters - Status of bone grafts if used (displaced/ resorbed/ healed)	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	pre-operative / 10 days / 12 months / 24 months
Secondary	Radiological parameters - Presence of ectopic bone	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	pre-operative / 10 days / 12 months / 24 months