Open Versus Endoscopic Surgery of Craniomaxillofacial (CMF) Condylar Neck Fractures
This study has been completed.
Sponsor:
AO Clinical Investigation and Documentation
Information provided by:
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00206011
First received: September 14, 2005
Last updated: January 29, 2009
Last verified: January 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Condylar Neck Fractures |
Procedure: Endoscopic surgery |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Versus Endoscopic Surgery of Condylar Neck Fractures |
Resource links provided by NLM:
Further study details as provided by AO Clinical Investigation and Documentation:
Primary Outcome Measures:
- Functional outcome based on the Helkimo dysfunction index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Complication rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Cost effectiveness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 134 |
| Study Start Date: | April 2003 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Procedure: Endoscopic surgery
Open surgical intervention compared to endoscopic intervention
|
| 2 |
Procedure: Endoscopic surgery
Open surgical intervention compared to endoscopic intervention
|
Detailed Description:
The primary outcome measure is functional outcome based on the Helkimo dysfunction index.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206011
Locations
| Germany | |
| Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie | |
| Freiburg, Germany, 79106 | |
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
| Principal Investigator: | Rainer Schmlezeisen, Prof. Dr. | Universitaet Freiburg |
More Information
No publications provided
| Responsible Party: | Judy He, AO Clinical Investigation of NA |
| ClinicalTrials.gov Identifier: | NCT00206011 History of Changes |
| Other Study ID Numbers: | 06-CMF-01 |
| Study First Received: | September 14, 2005 |
| Last Updated: | January 29, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by AO Clinical Investigation and Documentation:
|
Condylar neck fractures endoscopic Helkimo Dysfunction index |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013