A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor

Mandibular Fracture Clinical Trial

Official title:

A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850861
• Other study ID #: WCH-01
• Status: Completed
• Phase: N/A
• First received: July 6, 2016
• Last updated: July 29, 2016
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natrural Science Foundation
• Study type: Interventional

Clinical Trial Summary

In condylar fracture surgery, reduction is the most difficult step and the key factor which determined the postoperative outcome. Therefore, the aim of this study is to develop a new instrument, which the investigators call condylar redactor, to assist the surgeon to reduct the condylar segments effectively.

Description:

In this prospective cohort study, it involved condylar fractures patients who were received surgical treatment from January 2014 to June 2016. Patients in the experimental group were treated with the condylar reductor, and patients in the control group were treated with the traditional surgical instruments. The primary outcome variable was reduction time and reduction rate. The continuity correction X2 and test student t test were used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients aged 18-60 with mandibular condylar fractures were treated in Oral and maxillofacial surgery department, West China hospital of stomatology, China from January 2014 to January 2016.

Exclusion Criteria:

• patients refused to participate in the clinical trial;

• condylar fracture dislocation was not obvious, conservative treatment can be used;

• mandibular condylar comminuted fracture;

• mandibular condyle need to be reconstructed.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fracture
• Mandibular Fractures

Intervention

Device:
• Condylar reductor
A new surgical instrument was designed to assist the surgeons to perform condylar fracture reduction.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Junhui Cui	West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative reduction time		intraoperative	Yes

External Links

•   The West China Hospital of Stomatology has long been ranked as one of the national top hospitals in China