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Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

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ClinicalTrials.gov Identifier: NCT03991728
Recruitment Status : Not yet recruiting
First Posted : June 19, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

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.


Condition or disease
Temporomandibular Joint Disorders

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. The registry has no primary but several objectives. [ Time Frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months) ]
    due to the study design, no primary objective has been defined and therefore no primary outcome measure either


Secondary Outcome Measures :
  1. Demographics [ Time Frame: pre-operative ]
    Year of birth Gender Smoking

  2. Comorbidities [ Time Frame: pre-operative ]
    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

  3. Refusal of alloplastic total TMJ replacement surgery [ Time Frame: pre-operative ]
    For patients who require alloplastic total TMJ replacement but refuse surgery, the reason(s) for refusal will be collected.

  4. Clinical and functional outcomes - Mandibular movements [ Time Frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months) ]
    Interincisial opening/maximal opening Lateral movements Protrusive movement

  5. Clinical and functional outcomes - Occlusal status [ Time Frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months) ]
    Occlusion will be assessed according to Angle's classification:

  6. Clinical and functional outcomes - Dentition [ Time Frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months) ]

    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 .

  7. Clinical and functional outcomes - Helkimo Clinical dysfunction index [ Time Frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months) ]
    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.

  8. Patient Reported Outcomes - Pain numeric rating scale (NRS) [ Time Frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months) ]

    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.


  9. Patient Reported Outcomes - Jaw function NRS [ Time Frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months) ]
    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.

  10. Patient Reported Outcomes - Diet limitation NRS [ Time Frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months) ]
    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.

  11. Patient Reported Outcomes - EuroQoL five dimension (EQ-5D-5L) [ Time Frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months ]
    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.

  12. Patient Reported Outcomes - Oral Health Impact Profile (OHIP) - 14 [ Time Frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months ]
    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.

  13. Anticipated treatment or condition-related adverse events (i.e. complications) [ Time Frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months) ]

    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


  14. Survival [ Time Frame: 10 days / 3 months / 6 months / 12 months / 24 months / 60 months ]
    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.

  15. Radiological parameters - Displacement of ramus component [ Time Frame: pre-operative / 10 days / 12 months / 24 months ]
    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:

  16. Radiological parameters - Fracture of ramus component [ Time Frame: pre-operative / 10 days / 12 months / 24 months ]
    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

  17. Radiological parameters - Screw loosening [ Time Frame: pre-operative / 10 days / 12 months / 24 months ]
    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

  18. Radiological parameters - Resorption/ osteolysis of surrounding bone [ Time Frame: pre-operative / 10 days / 12 months / 24 months ]
    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

  19. Radiological parameters - Status of bone grafts if used (displaced/ resorbed/ healed) [ Time Frame: pre-operative / 10 days / 12 months / 24 months ]
    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

  20. Radiological parameters - Presence of ectopic bone [ Time Frame: pre-operative / 10 days / 12 months / 24 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring alloplastic total TMJ replacement
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991728


Contacts
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Contact: Daniela Voegtli +41 81 414 25 10 daniela.voegtli@aofoundation.org
Contact: Zsofia Molnar +41 44 200 24 78 Zsofia.Molnar@aofoundation.org

Locations
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United States, Texas
University of Texas Health Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Daniel Pérez, MD         
Colombia
Estetica Maxilofacial Not yet recruiting
Bogotá, Colombia
Contact: Fernando Briceno, MD         
Finland
Helsinki University Hospital
Helsinki, Finland
Germany
Universitätsklinikum Düsseldorf (UKD) Not yet recruiting
Düsseldorf, Germany, 40225
Contact: Majeed Rana, MD         
Hannover Medical School Not yet recruiting
Hannover, Germany, 30625
Contact: Rüdiger Zimmerer, MD         
Klinikum der LMU München
Munich, Germany, 80337
India
All India Institute of Medical Sciences (AIIMS) Not yet recruiting
New Delhi, India, 110029
Contact: Ajoy Roychoudhury, MD         
Netherlands
Erasmus Medisch Centrum Not yet recruiting
Rotterdam, Netherlands, 3075
Contact: Eppo Wolvius, MD         
South Africa
King Edward VIII Hospital Not yet recruiting
Durban, South Africa, 4030
Contact: Vivesh Rughubar, MD         
Spain
12 de Octubre University Hospital Not yet recruiting
Madrid, Spain, 28041
Contact: Gregorio S. Aniceto, MD         
Sweden
Falu Hospital Not yet recruiting
Falun, Sweden, 79182
Contact: Jani Talvilahti, MD         
Skåne University Hospital
Lund, Sweden
Uppsala University Hospital Not yet recruiting
Uppsala, Sweden, SE-75185
Contact: Andreas Thor, MD    +46 (0)18 611 6450    andreas.thor@akademiska.se   
Switzerland
Universitätsspital Basel Not yet recruiting
Basel, Switzerland
Contact: Florian Thieringer, MD         
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
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Principal Investigator: Andreas Thor, MD Oral and Maxillofacial surgery Uppsala University Hospital
Principal Investigator: Vinay V Kumar, MD Oral and Maxillofacial surgery Uppsala University Hospital

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Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT03991728     History of Changes
Other Study ID Numbers: TMJ Replacement
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AO Clinical Investigation and Documentation:
Temporomandibular joint
TMJ replacement
Trauma
Ankylosis
Degenerative joint disease
Registry

Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes