UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056286 |
|---|---|
| Receipt number | R000064319 |
| Scientific Title | Retrospective Analyses of Minimally Invasive Surgical Approaches for Maxillofacial Fractures |
| Date of disclosure of the study information | 2024/11/28 |
| Last modified on | 2024/11/28 10:02:04 |
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Basic information
Public title
Retrospective Analyses of Minimally Invasive Surgical Approaches for Maxillofacial Fractures
Acronym
RAMISAMF
Scientific Title
Retrospective Analyses of Minimally Invasive Surgical Approaches for Maxillofacial Fractures
Scientific Title:Acronym
RAMISAMF
Region
| Asia(except Japan) |
Condition
Condition
zygomatic fractures AND condylar fractures
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this retrospective clinical study is to evaluate the applicability of traditional treatment methods versus modified surgical techniques in patients with zygomatic arch fractures. Initially, the study will identify and define the patient populations suitable for each treatment approach. Subsequently, the study will analyze prognosis data from patients who have completed follow-up, including incidences of facial nerve temporal branch injury, temporal region depression, hematoma formation, and infections. The aim is to assess the effectiveness, reliability, and safety of the modified surgical techniques in preventing facial nerve damage, reducing postoperative complications, and ultimately improving patient outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Incidence of facial nerve temporal branch injury: The rate of facial nerve temporal branch injury in patients undergoing traditional treatment methods compared to those receiving modified surgical techniques.
2. Complication rates: The occurrence of complications such as temporal region depression, hematoma formation, and infections in both treatment groups.
3. Overall patient prognosis: Assessment of patient recovery outcomes, including healing time, aesthetic results, and quality of life post-surgery.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 3 | years-old | < |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) clinical and imaging diagnoses of zygomaticomaxillary complex or ZA fractures; (2) ZA fracture requiring surgical fixation; (3) no previous surgical treatment in maxillofacial region; (4) consent to the surgical treatment; (5) received plate fixation at ZA with a temporal hairline incision at the study host institution; (6) a minimum of 12 weeks post-operative follow-up.
Key exclusion criteria
(1) patient lost to follow-up; (2) incomplete medical records, lacking key information such as sequelae or performance of a modified surgical procedure; (3) other temporal region surgeries performed during the postoperative follow-up period.
Target sample size
160
Research contact person
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, Chengdu, Sichuan, China
TEL
+86-15680939510
jinlongchen@scu.edu.cn
Public contact
Name of contact person
| 1st name | Zihua |
| Middle name | |
| Last name | Tang |
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, Chengdu, Sichuan, China
TEL
+86-85501456
Homepage URL
tangzihua@stu.scu.edu.cn
Sponsor or person
Institute
West China Hospital of Stomatology, Sichuan University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee of Ethics of West China Hospital of Stomatology, Sichuan University
Address
14 3rd Section of Renmin South Rd, Chengdu, Sichuan, China
Tel
+86-85503406
41681695@qq.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
163
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
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Incidence of facial nerve temporal branch injury: The rate of facial nerve temporal branch injury in patients undergoing traditional treatment methods compared to those receiving modified surgical techniques.
2. Complication rates: The occurrence of complications such as temporal region depression, hematoma formation, and infections in both treatment groups.
3. Overall patient prognosis: Assessment of patient recovery outcomes, including healing time, aesthetic results, and quality of life post-surgery.
Management information
Registered date
| 2024 | Year | 11 | Month | 28 | Day |
Last modified on
| 2024 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064319
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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