UMIN-CTR Clinical Trial

Public title

Complication Analysis of Retroauricular Approach in the Management of Condylar Head and Neck Fractures

Acronym

Complication Analysis of Retroauricular Approach in the Management of Condylar Fractures

Scientific Title

Complication Analysis of Retroauricular Approach in the Management of Condylar Head and Neck Fractures

Scientific Title:Acronym

Complication Analysis of Retroauricular Approach in the Management of Condylar Head and Neck Fractures

Region

Asia(except Japan)

Condition

condylar fracture ORIF via retroauricular approach

Classification by specialty

Oral surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluation of the safety and complications of the retroauricular approach in condylar fracture surgery.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Facial nerve injury

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

9

years-old

<

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Clinically and radiographically confirmed middle or high condylar fractures;
(2) Underwent open reduction and internal fixation of the condylar fracture via a retroauricular approach;
(3) No previous surgical treatment in the maxillofacial region;
(4) Age between 9 and 65 years.

Key exclusion criteria

(1) Lost to follow-up;
(2) Incomplete medical records, missing key information such as postoperative complications or details of modified surgical procedures;
(3) Underwent other surgeries involving the temporomandibular joint region during the follow-up period;
(4) History of otitis media, external auditory canal inflammation, or congenital/developmental disorders;
(5) Preexisting temporomandibular joint disorder prior to trauma.

Target sample size

16

Name of lead principal investigator

1st name	Jinlong
Middle name
Last name	Chen

Organization

West China Hospital of Stomatology, Sichuan University

Division name

Department of Oral and Maxillofacial Surgery

Zip code

610041

Address

14 3rd Section of Renmin South Rd, Wuhou District, Chengdu

TEL

862885501456

Email

jinlongchen@scu.edu.cn

Name of contact person

1st name	Jiaxiang
Middle name
Last name	Zhang

Organization

West China Hospital of Stomatology, Sichuan University

Division name

Department of Oral and Maxillofacial Surgery

Zip code

610041

Address

14 3rd Section of Renmin South Rd, Wuhou District, Chengdu

TEL

862885501456

Homepage URL

Email

zdoc2022@163.com

Institute

West China Hospital of Stomatology, Sichuan University

Institute

Department

Personal name

Organization

West China Hospital of Stomatology, Sichuan University

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

West China Hospital of Stomatology, Sichuan University

Address

14 3rd Section of Renmin South Rd, Wuhou District, Chengdu

Tel

+86 28 8550 1479

Email

41681695@qq.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

11

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

16

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2024

Year

03

Month

01

Day

Date of IRB

2024

Year

11

Month

04

Day

Anticipated trial start date

2024

Year

03

Month

15

Day

Last follow-up date

2025

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Postoperative assessments parameters included mandibular movement and occlusal relationship, mouth opening, facial nerve function, wound infection, hematoma, salivary fistula, auriculotemporal nerve injuries, evaluation of anatomic deformity and stenosis of EAC and covert scar at the surgical site. Patients were queried about their hearing prior to the trauma and any sensory changes post-surgery during follow-ups at 1 and 3 months.
Condylar fracture diagnosis was based on anamnesis, clinical examination, and computed tomography (CT) scans. Condylar head fractures are classified into four types: A, B, C and M as per the classification by He et al. 12 The condylar neck was divided into high and low halves by bisecting the distance between the sigmoid notch line and the lateral pole line, following the AO CMF guidelines.
Mouth opening was defined as the maximum distance between the upper and lower central incisors at the midline. Facial nerve functions were assessed by House-Brackman Facial Nerve Grading system.

Registered date

2025

Year

11

Month

08

Day

Last modified on

2025

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068284