Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

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

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.

Study Overview

• Status: Recruiting
• Conditions: 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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Alix Frischknecht; Phone Number: +41 79 606 41 48; Email: alix.frischknecht@aofoundation.org

Study Locations

• Brazil
  • São Paulo, Brazil
    • Recruiting
    • Hospital BP - A Beneficência Portuguesa de São Paulo
    • Contact: Gabriel Pastore, MD
• Colombia
  • Bogotá, Colombia
    • Suspended
    • Estetica Maxilofacial
• Germany
  • Hannover, Germany, 30625
    • Recruiting
    • Hannover Medical School
    • Contact: Philippe Korn, MD; Email: korn.philippe@mh-hannover.de
  • Leipzig, Germany
    • Recruiting
    • University Hospital Leipzig
    • Contact: Rüdiger Zimmerer, MD; Phone Number: +49341-97204443; Email: Ruediger.Zimmerer@medizin.uni-leipzig.de
  • Munich, Germany, 80337
    • Recruiting
    • Klinikum der LMU München
    • Contact: Wenko Smolka, MD
• India
  • Bangalore, India
    • Recruiting
    • Sri Shankara Cancer Hospital and Research Center
    • Contact: Vinay V Kumar, MD
  • New Delhi, India, 110029
    • Terminated
    • All India Institute of Medical Sciences (AIIMS)
• Netherlands
  • Rotterdam, Netherlands, 3075
    • Recruiting
    • Erasmus Medisch Centrum
    • Contact: Eppo Wolvius, MD
• New Zealand
  • Christchurch, New Zealand
    • Terminated
    • Waikato DHB
  • Lower Hutt, New Zealand
    • Suspended
    • Hutt Hospital
• Pakistan
  • Lahore, Pakistan
    • Terminated
    • Mayo Hospital
• Poland
  • Olsztyn, Poland
    • Recruiting
    • Wojewodzki Specjalistyczny Szpital Dzieciecy
    • Contact: Krzysztof Dowgierd, MD; Phone Number: +48 89 539 32 61; Email: krzysztofdowgierd@gmail.com
• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation
    • Contact: Sergey Epifanov, MD
• Serbia
  • Belgrade, Serbia
    • Recruiting
    • Clinic for Maxillofacial Surgery, University of Belgrade
    • Contact: Drago Jelovac, MD; Phone Number: +381112685268; Email: drago.jelovac@stomf.bg.ac.rs
• South Africa
  • Durban, South Africa, 4030
    • Recruiting
    • King Edward VIII Hospital
    • Contact: Vivesh Rughubar, MD
• Spain
  • Madrid, Spain, 28041
    • Recruiting
    • 12 de Octubre University Hospital
    • Contact: Ignacio Zubillaga, MD
• Sweden
  • Falun, Sweden, 79182
    • Recruiting
    • Falu Hospital
    • Contact: Jani Talvilahti, MD
  • Lund, Sweden
    • Recruiting
    • Skane University Hospital
    • Contact: Martin Bengtsson, MD
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital
    • Contact: Mattias Ulmner, MD
  • Uppsala, Sweden, SE-75185
    • Recruiting
    • Uppsala University Hospital
    • Contact: Andreas Thor, MD; Phone Number: +46 (0)18 611 6450; Email: andreas.thor@akademiska.se
• Switzerland
  • Basel, Switzerland
    • Recruiting
    • Universitatsspital Basel
    • Contact: Florian Thieringer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring alloplastic total TMJ replacement

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Year of birth Gender Smoking	pre-operative
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
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
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)
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)
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)
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)
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)
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)
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)
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
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
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)
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Registry; Trauma; Temporomandibular joint; Degenerative joint disease; TMJ replacement; Ankylosis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: TMJ Replacement

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No