Skip to main content
OpenTrials
Completed

NCT Number: NCT02850861

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mandibular Fracture Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Mandibular Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Condylar reductor

Device

A new surgical instrument was designed to assist the surgeons to perform condylar fracture reduction.

Primary outcomes

  1. intraoperative reduction time

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

Junhui Cui

Other

Collaborators

  • West China Hospital

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 1, 2016
Registry last updated
Aug 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.