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Open Versus Endoscopic Surgery of Craniomaxillofacial (CMF) Condylar Neck Fractures

Open Versus Endoscopic Surgery of Condylar Neck Fractures

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00206011
Enrollment
134
Registered
2005-09-21
Start date
2003-04-30
Completion date
2009-01-31
Last updated
2020-08-14

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

Conditions

Condylar Neck Fractures

Keywords

Condylar neck, fractures, endoscopic, Helkimo Dysfunction index

Brief summary

This study is a comparison of open surgery versus an endoscopic approach in condylar neck fractures; it will look at functional outcome, cosmetic outcome and patient satisfaction.

Detailed description

The primary outcome measure is functional outcome based on the Helkimo dysfunction index.

Interventions

PROCEDUREEndoscopic surgery

Open surgical intervention compared to endoscopic intervention

Sponsors

AO Clinical Investigation and Publishing Documentation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* Adult patient \> 18 years * Unilateral or bilateral fracture of the condylar neck * Inclination of the condyle \> 30% * Severe dislocation * Severe pain upon palpation/movement * Eligible for open reduction and internal fixation of the fracture * Amenable to endoscopic as well as open surgery

Exclusion criteria

* High or intracapsular condylar neck fracture * Very low fractures that can be reduced intraorally * CMF malfunctioning * Drug or alcohol abuse * General or local conditions that adversely affect bone physiology * Physical or mental incapacity to sign informed consent

Design outcomes

Primary

MeasureTime frame
Functional outcome based on the Helkimo dysfunction index3 months

Secondary

MeasureTime frame
Complication rate24 months
Cost effectiveness24 months

Countries

Germany

Outcome results

None listed

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