Condylar Process of Mandible Open FractureCHOC1NCT03264196
Condylar Head Operative or Conservative 1
A study testing Open Reduction and Internal Fixation in people with Condylar Process of Mandible Open Fracture, run by Oxford University Hospitals NHS Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Condylar Process of Mandible Open Fracture
- What is being tested?
- Open Reduction and Internal Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 24 Jan 2018to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospital Coventry
Coventry, Warwickshire, CV2 2DX
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
About this study
Official title: Condylar Head Operative or Conservative 1, Randomised Controlled Trial
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.
Read the 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 risks in itself, most of the evidence would suggest that outcomes are not quite as good as operative management. Operative treatment has complications that are not presented by conservative treatment, such as the risk of infection or facial nerve injury and therefore it is important to demonstrate that such treatment has sufficient benefits to merit it's consideration, and to properly inform the patients about the benefits and risks of treatment. When patients present with these injuries it is currently difficult to provide them with good evidence for them to make an informed decision with, as to whether to undergo surgery or not. At present the patient is expected to make a decision as to whether to have surgery or not based on this limited knowledge, and it is the investigator's experience with consulting these patients and the questions they asked that has demonstrated the need for and guided the design of the trial focusing on a patient related outcome quality of life measure, rather than the common objective measures.#
The main purpose of undertaking this RCT is to directly compare the results of operative and conservative management focusing on an outcome which is determined by the patients perception of their function and quality of life rather than purely objective measurements. A randomised controlled trial would provide the strongest level of evidence to support future care decisions and any patient with a unilateral fracture would be considered for inclusion if they can give informed consent and are able to complete the PROM questionnaire at the necessary time points. Exclusion criteria are limited, but include bilateral fractures because these are less common and the results may not be directly comparable.
The trial design has been kept simple and adds no significant burden to patients as all aspects of care and follow up are the same as the current standard of care apart from the completion of the questionnaire, which can be completed relatively quickly during participant's clinic appointments. The investigators are experienced surgeons in this field and able to fully answer any questions from patients with regards to the trial, and to risks and benefits of either treatment option. Neither has any conflict of interest in undertaking the trial.
All trial data will be handled confidentially in line with good governance procedures, and will be monitored by appropriate persons from the trial sponsors.
- Being tested
- Open Reduction and Internal Fixation
- Keywords
- condylar hear, fracture, randomised controlled trial
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Reduction and Internal FixationProcedure or surgery
Surgical treatment of fracture
| Study group | Role | What they receive |
|---|---|---|
| Operative | Active comparator | Open Reduction and Internal Fixation of Condylar Head Fracture Receives: Procedure: Open Reduction and Internal Fixation |
| Conservative | No intervention | Non-operatively managed Condylar Head Fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in functional self reported outcome measure
Difference in function assessed using Mandibular Functional Impairment Questionnaire
Measured: 12 months
Secondary outcomes (7)
Fracture Reduction
Post operative fracture reduction (ramus / condyle height - fracture side compared to normal on post operative OPG)
Measured: 12 months
Mouth Opening
Mean interincisal opening- mm
Measured: 12 months
Mandibular lateral movements
Mean lateral excursion from affected side - mm
Measured: 12 months
Mandibular protrusion
Mean Protrusion - mm
Measured: 12 months
Pain Score
Pain - linkart score (0-10)
Measured: 12 months
Dietary interference
Dietary interference - linkart score (0-10)
Measured: 12 months
Mandibular functional impairment
Functional impairment rating scale (1-4)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start24 Jan 2018
- Primary completion30 Sep 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condylar Process of Mandible Open FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niall Mcleod, Oxford University Hospitals NHS Trust
- Investigators
- Niall MH Mcleod, FRCS(OMFS), Principal investigator, Oxford University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264196
- Sponsor's protocol ID
- 12513
- Acronym
- CHOC1
- Status last verified
- Jan 2026
- First submitted
- 21 Aug 2017
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Condylar Head Operative or Conservative 1, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03264196
- Acronym / sponsor ID
- CHOC1 / 12513
- Keywords
- condylar hear, fracture, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 risks in itself, most of the evidence would suggest that outcomes are not quite as good as operative management. Operative treatment has complications that are not presented by conservative treatment, such as the risk of infection or facial nerve injury and therefore it is important to demonstrate that such treatment has sufficient benefits to merit it's consideration, and to properly inform the patients about the benefits and risks of treatment. When patients present with these injuries it is currently difficult to provide them with good evidence for them to make an informed decision with, as to whether to undergo surgery or not. At present the patient is expected to make a decision as to whether to have surgery or not based on this limited knowledge, and it is the investigator's experience with consulting these patients and the questions they asked that has demonstrated the need for and guided the design of the trial focusing on a patient related outcome quality of life measure, rather than the common objective measures.#
The main purpose of undertaking this RCT is to directly compare the results of operative and conservative management focusing on an outcome which is determined by the patients perception of their function and quality of life rather than purely objective measurements. A randomised controlled trial would provide the strongest level of evidence to support future care decisions and any patient with a unilateral fracture would be considered for inclusion if they can give informed consent and are able to complete the PROM questionnaire at the necessary time points. Exclusion criteria are limited, but include bilateral fractures because these are less common and the results may not be directly comparable.
The trial design has been kept simple and adds no significant burden to patients as all aspects of care and follow up are the same as the current standard of care apart from the completion of the questionnaire, which can be completed relatively quickly during participant's clinic appointments. The investigators are experienced surgeons in this field and able to fully answer any questions from patients with regards to the trial, and to risks and benefits of either treatment option. Neither has any conflict of interest in undertaking the trial.
All trial data will be handled confidentially in line with good governance procedures, and will be monitored by appropriate persons from the trial sponsors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Operative | Active comparator | Procedure: Open Reduction and Internal FixationOpen Reduction and Internal Fixation of Condylar Head Fracture |
| Conservative | No intervention | –Non-operatively managed Condylar Head Fracture |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Reduction and Internal FixationSurgical treatment of fracture | Procedure or surgery | Operative |
Primary outcome
Difference in functional self reported outcome measure
Time frame: 12 months
Difference in function assessed using Mandibular Functional Impairment Questionnaire
7 secondary outcomes
Fracture Reduction
Time frame: 12 months
Mouth Opening
Time frame: 12 months
Mandibular lateral movements
Time frame: 12 months
Mandibular protrusion
Time frame: 12 months
Pain Score
Time frame: 12 months
Dietary interference
Time frame: 12 months
Mandibular functional impairment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Condylar Process of Mandible Open Fracture
Recruiting
Treatment of Intra-articular Fractures of the Mandibular Condyle
Intra-articular Fracture of the Mandibular Condyle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niall MH Mcleod, FRCS(OMFS) principal investigator
Oxford University Hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Reduction and Internal Fixation in people with Condylar Process of Mandible Open Fracture, run by Oxford University Hospitals NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in functional self reported outcome measure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.