ClinicalTrials.gov
ClinicalTrials.gov Menu

Condylar Head Operative or Conservative 1 (CHOC1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03264196
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Niall Mcleod, Oxford University Hospitals NHS Trust

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.

Condition or disease Intervention/treatment Phase
Condylar Process of Mandible Open Fracture Procedure: Open Reduction and Internal Fixation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Condylar Head Operative or Conservative 1, Randomised Controlled Trial
Estimated Study Start Date : April 12, 2018
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: Operative
Open Reduction and Internal Fixation of Condylar Head Fracture
Procedure: Open Reduction and Internal Fixation
Surgical treatment of fracture

No Intervention: Conservative
Non-operatively managed Condylar Head Fracture



Primary Outcome Measures :
  1. Difference in functional self reported outcome measure [ Time Frame: 12 months ]
    Difference in function assessed using Mandibular Functional Impairment Questionnaire


Secondary Outcome Measures :
  1. Fracture Reduction [ Time Frame: 12 months ]
    Post operative fracture reduction (ramus / condyle height - fracture side compared to normal on post operative OPG)

  2. Mouth Opening [ Time Frame: 12 months ]
    Mean interincisal opening- mm

  3. Mandibular lateral movements [ Time Frame: 12 months ]
    Mean lateral excursion from affected side - mm

  4. Mandibular protrusion [ Time Frame: 12 months ]
    Mean Protrusion - mm

  5. Pain [ Time Frame: 12 months ]
    Pain - linkart score (0-10)

  6. Dietary interference [ Time Frame: 12 months ]
    Dietary interference - linkart score (0-10)

  7. Mandibular functional impairment [ Time Frame: 12 months ]
    Functional impairment rating scale (1-4)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264196


Contacts
Contact: Niall MH McLeod, FRCS(OMFS) 01865743102 niall.mcleod@ouh.nhs.uk

Locations
United Kingdom
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Niall McLeod    +441865743102    niall.mcleod@nhs.net   
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
Principal Investigator: Niall MH Mcleod, FRCS(OMFS) Oxford University Hospitals

Responsible Party: Niall Mcleod, Consultant Oral and Maxillofacial Surgeon, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03264196     History of Changes
Other Study ID Numbers: 12513
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Niall Mcleod, Oxford University Hospitals NHS Trust:
condylar hear
fracture
randomised controlled trial

Additional relevant MeSH terms:
Fractures, Open
Jaw Fractures
Fractures, Bone
Wounds and Injuries
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures