NCT03991728

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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
92mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
14 countries

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Oct 2019Dec 2033

First Submitted

Initial submission to the registry

June 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2032

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2033

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

12.9 years

First QC Date

June 12, 2019

Last Update Submit

February 17, 2026

Conditions

Temporomandibular Joint Disorders

Keywords

Temporomandibular jointTMJ replacementTraumaAnkylosisDegenerative joint diseaseRegistry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (20)

  • Demographics

    pre-operative

  • Comorbidities

    pre-operative

  • Refusal of alloplastic total TMJ replacement surgery

    pre-operative

  • Clinical and functional outcomes - Mandibular movements

    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

    from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)

  • +15 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients requiring alloplastic total TMJ replacement

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Hospital BP - A Beneficência Portuguesa de São Paulo

São Paulo, Brazil

RECRUITING

Estetica Maxilofacial

Bogotá, Colombia

SUSPENDED

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

University Hospital Leipzig

Leipzig, Germany

RECRUITING

Klinikum der Johannes Gutenberg Universität Mainz

Mainz, 55131, Germany

NOT YET RECRUITING

Klinikum der LMU München

Munich, 80337, Germany

RECRUITING

Sri Shankara Cancer Hospital and Research Center

Bangalore, India

RECRUITING

All India Institute of Medical Sciences (AIIMS)

New Delhi, 110029, India

TERMINATED

Erasmus Medisch Centrum

Rotterdam, 3075, Netherlands

RECRUITING

Waikato DHB

Christchurch, New Zealand

TERMINATED

Hutt Hospital

Lower Hutt, New Zealand

SUSPENDED

Mayo Hospital

Lahore, Pakistan

TERMINATED

Wojewódzki Specjalistyczny Szpital Dziecięcy

Olsztyn, Poland

RECRUITING

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

Moscow, Russia

RECRUITING

Clinic for Maxillofacial Surgery, University of Belgrade

Belgrade, Serbia

RECRUITING

King Edward VIII Hospital

Durban, 4030, South Africa

RECRUITING

12 de Octubre University Hospital

Madrid, 28041, Spain

RECRUITING

Falu Hospital

Falun, 79182, Sweden

RECRUITING

Skåne University Hospital

Lund, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, SE-75185, Sweden

RECRUITING

Universitätsspital Basel

Basel, Switzerland

RECRUITING

Related Publications (1)

  • Thor A, Bengtsson M, Dowgierd K, Epifanov S, Fichter AM, Jelovac D, Korn PN, Nilsson JL, Pastore G, Rughubar V, Smolka W, Talvilahti J, Thiem D, Thieringer F, Ulmner M, Wolvius EB, Zubillaga Rodriguez I, Kumar VV. Alloplastic total temporomandibular joint (TMJ) replacement registry: a protocol for a prospective global multicentre observational cohort study. BMJ Open. 2026 Mar 9;16(3):e113558. doi: 10.1136/bmjopen-2025-113558.

    PMID: 41802784DERIVED

MeSH Terms

Conditions

Temporomandibular Joint DisordersWounds and InjuriesAnkylosisJoint Diseases

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Andreas Thor, MD

    Oral and Maxillofacial surgery Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

  • Vinay V Kumar, MD

    Oral and Maxillofacial surgery Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Viola Grünenfelder

CONTACT

+41 79 696 33 97viola.gruenenfelder@aofoundation.org

Aleksandra Hodor

CONTACT

aleksandra.hodor@aofoundation.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2019

First Posted

June 19, 2019

Study Start

October 15, 2019

Primary Completion (Estimated)

September 1, 2032

Study Completion (Estimated)

December 1, 2033

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)NZ(2)IN(2)RU(1)DE(4)PL(1)CH(1)DK(1)NL(1)BR(1)ES(1)PA(1)ZA(1)CO(1)