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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02850861
Enrollment
2
Registered
2016-08-01
Start date
2014-01-31
Completion date
2016-06-30
Last updated
2016-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular Fracture

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.

Detailed 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.

Interventions

DEVICECondylar reductor

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

Sponsors

West China Hospital
CollaboratorOTHER
Junhui Cui
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
intraoperative reduction timeintraoperative

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026