Condylar Neck FracturesPhase 4NCT00206011
Open Versus Endoscopic Surgery of Craniomaxillofacial (CMF) Condylar Neck Fractures
A Phase 4 study testing Endoscopic surgery in people with Condylar Neck Fractures, run by AO Clinical Investigation and Publishing Documentation at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Condylar Neck Fractures
- What is being tested?
- Endoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2003to Jan 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie
Freiburg im Breisgau, 79106
About this study
Official title: Open Versus Endoscopic Surgery of Condylar Neck Fractures
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.
Read the detailed description
The primary outcome measure is functional outcome based on the Helkimo dysfunction index.
- Conditions
- Condylar Neck Fractures
- Being tested
- Endoscopic surgery
- Keywords
- Condylar neck, fractures, endoscopic, Helkimo Dysfunction index
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic surgeryProcedure or surgery
Open surgical intervention compared to endoscopic intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Endoscopic surgery |
| 2 | Other | Not described Receives: Procedure: Endoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome based on the Helkimo dysfunction index
Measured: 3 months
Secondary outcomes (2)
Complication rate
Measured: 24 months
Cost effectiveness
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionOct 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condylar Neck FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Schmlezeisen, Prof. Dr., Principal investigator, Universitaet Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206011
- Sponsor's protocol ID
- 06-CMF-01
- Status last verified
- Aug 2020
- First submitted
- 14 Sep 2005
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Endoscopic Surgery of Condylar Neck Fractures
- ClinicalTrials.gov ID
- NCT00206011
- Acronym / sponsor ID
- 06-CMF-01
- Conditions
- Condylar Neck Fractures
- Keywords
- Condylar neck, fractures, endoscopic, Helkimo Dysfunction index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Endoscopic surgery |
| 2 | Other | Procedure: Endoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patient > 18 years
- Unilateral or bilateral fracture of the condylar neck
- Inclination of the condyle > 30%
- Severe dislocation
- Severe pain upon palpation/movement
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic surgeryOpen surgical intervention compared to endoscopic intervention | Procedure or surgery | 1, 2 |
Primary outcome
Functional outcome based on the Helkimo dysfunction index
Time frame: 3 months
2 secondary outcomes
Complication rate
Time frame: 24 months
Cost effectiveness
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Schmlezeisen, Prof. Dr. principal investigator
Universitaet Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endoscopic surgery in people with Condylar Neck Fractures, run by AO Clinical Investigation and Publishing Documentation at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome based on the Helkimo dysfunction index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.