NCT03264196

Brief Summary

The condylar head is the part of the lower jaw which forms the joint. Displaced fractures of this area are uncommon but can cause problems with function, such as chewing, if not treated effectively. The medical literature does not have a clear consensus on whether these should be treated operatively (with surgery to reduce and fix the fracture) or conservatively (with advice and exercise and no surgery). The investigators propose a randomised controlled trial comparing the outcome of the operative or conservative treatment of condylar head fractures of the mandible, primarily with regards to patient related outcome measures of mandibular function, and secondarily objective measures of mandibular movement, function and symptoms to try and provide a clearer answer as to the best way of managing them.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 24, 2018

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

6.7 years

First QC Date

August 21, 2017

Last Update Submit

January 13, 2026

Conditions

Condylar Process of Mandible Open Fracture

Keywords

condylar hearfracturerandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Difference in functional self reported outcome measure

    Difference in function assessed using Mandibular Functional Impairment Questionnaire

    12 months

Secondary Outcomes (7)

  • Fracture Reduction

    12 months

  • Mouth Opening

    12 months

  • Mandibular lateral movements

    12 months

  • Mandibular protrusion

    12 months

  • Pain Score

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Operative

ACTIVE COMPARATOR

Open Reduction and Internal Fixation of Condylar Head Fracture

Procedure: Open Reduction and Internal Fixation

Conservative

NO INTERVENTION

Non-operatively managed Condylar Head Fracture

Interventions

Open Reduction and Internal FixationPROCEDURE

Surgical treatment of fracture

Operative

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the trial.
  • Male or Female, aged 18 years or above.
  • Be in good health - suitable for general anaesthesia for surgical treatment
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
  • Unilateral condylar head fracture with or without other mandibular body or angle fractures, or other maxillofacial injuries
  • Condylar head fracture displaced by at least 2 mm measured on coronal or sagittal CT scan
  • In the Investigator's opinion, is able and willing to comply with all trial requirements.

You may not qualify if:

  • Undisplaced condylar head fractures, or displaced less than 2 mm on coronal or sagittal CT
  • Bilateral condylar head fractures
  • Pre-existing congenital or acquired pathology of the ipsilateral or contralateral temporomandibular joint - including but not limited to ankylosis, inflammatory arthropathy, idiopathic condylar resorption
  • Pregnancy (increased risk of joint pain and laxity)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Coventry

Coventry, Warwickshire, CV2 2DX, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Open Fracture ReductionFracture Fixation, Internal

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Niall MH Mcleod, FRCS(OMFS)

    Oxford University Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Oral and Maxillofacial Surgeon

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 29, 2017

Study Start

January 24, 2018

Primary Completion

September 30, 2024

Study Completion

September 30, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)