Status:
UNKNOWN
Condylar Head Operative or Conservative 1
Lead Sponsor:
Oxford University Hospitals NHS Trust
Conditions:
Condylar Process of Mandible Open Fracture
Eligibility:
All Genders
18-99 years
Phase:
NA
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. T...
Detailed Description
The current medical literature provides conflicting evidence as to the benefits of operative or conservative management of displaced condylar head fractures. Whilst conservative treatment has few risk...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03264196
Start Date
January 24 2018
End Date
January 1 2026
Last Update
September 21 2023
Active Locations (2)
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1
University Hospital Coventry
Coventry, Warwickshire, United Kingdom, CV2 2DX
2
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 9DU