Condylar Head Operative or Conservative 1 (CHOC1)

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.

Study Overview

• Status: Recruiting
• Conditions: Condylar Process of Mandible Open Fracture
• Intervention / Treatment: Procedure: Open Reduction and Internal Fixation

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
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Niall MH McLeod, FRCS(OMFS); Phone Number: 01865743102; Email: niall.mcleod@nhs.net

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • Recruiting
    • Oxford University Hospitals NHS Foundation Trust
    • Contact: Barbara Gerber; Phone Number: +441865743101; Email: barbara.gerber@ouh.nhs.uk
  • Warwickshire
    • Coventry, Warwickshire, United Kingdom, CV2 2DX
      • Recruiting
      • University Hospital Coventry
      • Contact: Niall M H McLeod; Phone Number: 02476965854; Email: niall.mcleod@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in functional self reported outcome measure	Difference in function assessed using Mandibular Functional Impairment Questionnaire	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture Reduction	Post operative fracture reduction (ramus / condyle height - fracture side compared to normal on post operative OPG)	12 months
Mouth Opening	Mean interincisal opening- mm	12 months
Mandibular lateral movements	Mean lateral excursion from affected side - mm	12 months
Mandibular protrusion	Mean Protrusion - mm	12 months
Pain Score	Pain - linkart score (0-10)	12 months
Dietary interference	Dietary interference - linkart score (0-10)	12 months
Mandibular functional impairment	Functional impairment rating scale (1-4)	12 months

Collaborators and Investigators

• Sponsor: Oxford University Hospitals NHS Trust
• Investigators: Principal Investigator: Niall MH Mcleod, FRCS(OMFS), Oxford University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2018
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: fracture; randomised controlled trial; condylar hear
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Open
• Other Study ID Numbers: 12513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No