NCT02850861

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

July 6, 2016

Last Update Submit

July 29, 2016

Conditions

Mandibular Fracture

Outcome Measures

Primary Outcomes (1)

  • intraoperative reduction time

    intraoperative

Study Arms (2)

The experimental group

EXPERIMENTAL

In this group, the condylar reductor was applied in the surgical treatment of mandibular condylar fractures.

Device: Condylar reductor

The control group

NO INTERVENTION

In this group, traditional surgical instruments were applied in the surgical treatment of mandibular condylar fractures.

Interventions

Condylar reductorDEVICE

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

The experimental group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Study Officials

  • Lei Liu, MD

    West China Hospital of Stomotalogy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 6, 2016

First Posted

August 1, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

August 1, 2016

Record last verified: 2016-07