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Condylar Head Operative or Conservative 1 (CHOC1)

Primary Purpose

Condylar Process of Mandible Open Fracture

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Open Reduction and Internal Fixation
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Condylar Process of Mandible Open Fracture focused on measuring condylar hear, fracture, randomised controlled trial

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University Hospital CoventryRecruiting
  • Oxford University Hospitals NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Operative

Conservative

Arm Description

Open Reduction and Internal Fixation of Condylar Head Fracture

Non-operatively managed Condylar Head Fracture

Outcomes

Primary Outcome Measures

Difference in functional self reported outcome measure
Difference in function assessed using Mandibular Functional Impairment Questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
August 21, 2017
Last Updated
September 19, 2023
Sponsor
Oxford University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03264196
Brief Title
Condylar Head Operative or Conservative 1
Acronym
CHOC1
Official Title
Condylar Head Operative or Conservative 1, Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2018 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford University Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Condylar Process of Mandible Open Fracture
Keywords
condylar hear, fracture, randomised controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Operative
Arm Type
Active Comparator
Arm Description
Open Reduction and Internal Fixation of Condylar Head Fracture
Arm Title
Conservative
Arm Type
No Intervention
Arm Description
Non-operatively managed Condylar Head Fracture
Intervention Type
Procedure
Intervention Name(s)
Open Reduction and Internal Fixation
Intervention Description
Surgical treatment of fracture
Primary Outcome Measure Information:
Title
Difference in functional self reported outcome measure
Description
Difference in function assessed using Mandibular Functional Impairment Questionnaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Fracture Reduction
Description
Post operative fracture reduction (ramus / condyle height - fracture side compared to normal on post operative OPG)
Time Frame
12 months
Title
Mouth Opening
Description
Mean interincisal opening- mm
Time Frame
12 months
Title
Mandibular lateral movements
Description
Mean lateral excursion from affected side - mm
Time Frame
12 months
Title
Mandibular protrusion
Description
Mean Protrusion - mm
Time Frame
12 months
Title
Pain Score
Description
Pain - linkart score (0-10)
Time Frame
12 months
Title
Dietary interference
Description
Dietary interference - linkart score (0-10)
Time Frame
12 months
Title
Mandibular functional impairment
Description
Functional impairment rating scale (1-4)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niall MH McLeod, FRCS(OMFS)
Phone
01865743102
Email
niall.mcleod@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niall MH Mcleod, FRCS(OMFS)
Organizational Affiliation
Oxford University Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Coventry
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niall M H McLeod
Phone
02476965854
Email
niall.mcleod@nhs.net
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Gerber
Phone
+441865743101
Email
barbara.gerber@ouh.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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Condylar Head Operative or Conservative 1

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