Actively Recruiting

Age: 18Years +
All Genders
ID03991728

International Multicenter Prospective Registry to Collect Data on Patients Treated With Alloplastic Total Temporomandibular Joint Replacement

Led by AO Innovation Translation Center · Updated on 2026-02-18

200

Participants Needed

23

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are collecting prospective data from about 200 patients who receive alloplastic total temporomandibular joint (TMJ) replacements. This registry aims to understand the clinical reasons for TMJ replacement, treatment patterns across regions, patient outcomes including pain, jaw movement, and quality of life, as well as reasons why some patients refuse this surgery. The study is observational and does not assign specific treatments but records routine care provided by individual clinicians. Patients undergoing TMJ replacement will be followed for up to 5 years after their surgery, with assessments at multiple time points including 10 days, 3 months, 6 months, 12 months, 24 months, and 60 months. Data collected include treatment details, clinical evaluations such as mandibular movements and occlusal status, patient-reported outcomes like pain and diet limitations, as well as radiological parameters and any complications that occur. Cases of patients who refuse the TMJ replacement will also be registered. Participants will be monitored through pre-operative and post-operative assessments covering functional outcomes, quality of life questionnaires, and imaging studies. Researchers will track adverse events, survival, and other clinical factors over the five-year period. The registry collects detailed data on demographics, comorbidities, and treatment outcomes to explore predictors of favorable results and improve understanding of TMJ replacement effects.

CONDITIONS

Brief Title

Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years and older
  • Patients requiring alloplastic total TMJ replacement
  • Ability to understand the informed consent form
  • Willingness and ability to participate in the registry
  • Signed and dated ethics committee or institutional review board approved informed consent
Not Eligible

You will not qualify if you...

  • Recent history of substance abuse that would affect reliable assessment
  • Pregnancy or planning to conceive during the study period
  • Participation in other medical device or drug studies within the previous month that could influence this study's results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 10 days or until discharge

Participants undergo alloplastic total temporomandibular joint (TMJ) replacement surgery and receive immediate post-operative care as part of routine clinical treatment.

Visits around the surgery and during immediate recovery

Post-operative Follow-up

Duration - Up to 60 months after surgery

Participants are followed to assess clinical and functional outcomes, quality of life, and potential complications after TMJ replacement surgery.

Visits at 10 days, 3 months, 6 months, 12 months, 24 months, and 60 months post-surgery

Trial Site Locations

Total: 23 locations

1

Hospital BP - A Beneficência Portuguesa de São Paulo

São Paulo, Brazil

Actively Recruiting

2

Estetica Maxilofacial

Bogotá, Colombia

Suspended

3

Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

4

Hannover Medical School

Hanover, Germany, 30625

Actively Recruiting

5

University Hospital Leipzig

Leipzig, Germany

Actively Recruiting

6

Klinikum der Johannes Gutenberg Universität Mainz

Mainz, Germany, 55131

Not Yet Recruiting

7

Klinikum der LMU München

Munich, Germany, 80337

Actively Recruiting

8

Sri Shankara Cancer Hospital and Research Center

Bangalore, India

Actively Recruiting

9

All India Institute of Medical Sciences (AIIMS)

New Delhi, India, 110029

Terminated

10

Erasmus Medisch Centrum

Rotterdam, Netherlands, 3075

Actively Recruiting

11

Waikato DHB

Christchurch, New Zealand

Terminated

12

Hutt Hospital

Lower Hutt, New Zealand

Suspended

13

Mayo Hospital

Lahore, Pakistan

Terminated

14

Wojewódzki Specjalistyczny Szpital Dziecięcy

Olsztyn, Poland

Actively Recruiting

15

National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation

Moscow, Russia

Actively Recruiting

16

Clinic for Maxillofacial Surgery, University of Belgrade

Belgrade, Serbia

Actively Recruiting

17

King Edward VIII Hospital

Durban, South Africa, 4030

Actively Recruiting

18

12 de Octubre University Hospital

Madrid, Spain, 28041

Actively Recruiting

19

Falu Hospital

Falun, Sweden, 79182

Actively Recruiting

20

Skåne University Hospital

Lund, Sweden

Actively Recruiting

21

Karolinska University Hospital

Stockholm, Sweden

Actively Recruiting

22

Uppsala University Hospital

Uppsala, Sweden, SE-75185

Actively Recruiting

23

Universitätsspital Basel

Basel, Switzerland

Actively Recruiting

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Research Team

V

Viola Grünenfelder

A

Aleksandra Hodor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Alloplastic total temporomandibular joint (TMJ) replacement registry: a protocol for a prospective global multicentre observational cohort study.

Andreas Thor, Martin Bengtsson, Krzysztof Dowgierd...

https://pubmed.ncbi.nlm.nih.gov/41802784