Odontoid Fractures Type IIPhase 4NCT00283998
Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
A Phase 4 study testing surgical versus conservative treatment in people with Odontoid Fractures Type II, run by AO Clinical Investigation and Publishing Documentation at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients >/= 65 years of age. Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Odontoid Fractures Type II
- What is being tested?
- surgical versus conservative treatment
- Type of treatment
- Surgery or procedure
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Mar 2012
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- All new type II odontoid fractures including < those in which the fracture line crosses into the body of C2 < as long as it doesn't enter the superior articular process of C2
- Age 65+
- Stable and unstable fractures
- < 3 months postinjury
- No previous treatment for an odontoid fracture
Who cannot join
- Pathologic fractures unrelated to osteoporosis
- Severe dementia or other severe mental health problem if there is no consentable surrogate available
- Participating in other trials or unlikely to attend follow-ups
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University SOM: Orthopedics
Atlanta, Georgia, 35037
About this study
Official title: Phase 4 Study Comparing Surigcal to Conservative Management of Type 2 Odontoid Fractures
The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients >/= 65 years of age. Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.
- Conditions
- Odontoid Fractures Type II
- Being tested
- surgical versus conservative treatment
- Keywords
- Odontoid, Type II fractures, Elderly patients, Surgical vs. conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical versus conservative treatmentProcedure or surgery
Surgical treatment of fractures versus conservative stabilization
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life using the Neck disability Index
Measured: 12 months
Quality of life using the SF-36
Measured: 12 months
Proportion of bony fusion between the two treatments
Measured: 6 months
Proportion rate of non-union between the two treatments
Measured: 6 months
Secondary outcomes (3)
Rate of complications
Measured: 12 months
Cervical range of motion
Measured: 12 months
Identify the risk factors for a poor outcome independent of treatment intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionOct 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Odontoid Fractures Type IIStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- AOSpine North America
- Responsible party
- Sponsor
- Investigators
- Alexander R Vaccaro, MD, Principal investigator, Th. Jefferson University Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283998
- Sponsor's protocol ID
- 06-Odont-02
- Status last verified
- Mar 2014
- First submitted
- 30 Jan 2006
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study Comparing Surigcal to Conservative Management of Type 2 Odontoid Fractures
- ClinicalTrials.gov ID
- NCT00283998
- Acronym / sponsor ID
- 06-Odont-02
- Conditions
- Odontoid Fractures Type II
- Keywords
- Odontoid, Type II fractures, Elderly patients, Surgical vs. conservative treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- AOSpine North America
- Study start
- Jan 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 31 Jan 2006 (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.
The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients >/= 65 years of age. Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- All new type II odontoid fractures including < those in which the fracture line crosses into the body of C2 < as long as it doesn't enter the superior articular process of C2
- Age 65+
- Stable and unstable fractures
- < 3 months postinjury
- No previous treatment for an odontoid fracture
Key exclusion criteria (3 listed)
- Pathologic fractures unrelated to osteoporosis
- Severe dementia or other severe mental health problem if there is no consentable surrogate available
- Participating in other trials or unlikely to attend follow-ups
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 |
|---|---|---|
| surgical versus conservative treatmentSurgical treatment of fractures versus conservative stabilization | Procedure or surgery | – |
Primary outcome
Quality of life using the Neck disability Index
Time frame: 12 months
Quality of life using the SF-36
Time frame: 12 months
Proportion of bony fusion between the two treatments
Time frame: 6 months
Proportion rate of non-union between the two treatments
Time frame: 6 months
3 secondary outcomes
Rate of complications
Time frame: 12 months
Cervical range of motion
Time frame: 12 months
Identify the risk factors for a poor outcome independent of treatment intervention
Time frame: 12 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 26 Mar 2014.
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.
Alexander R Vaccaro, MD principal investigator
Th. Jefferson University Philadelphia
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 surgical versus conservative treatment in people with Odontoid Fractures Type II, run by AO Clinical Investigation and Publishing Documentation at 1 site in United States.
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 5 inclusion and 3 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 26 Mar 2014. 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 United States. 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?
Quality of life using the Neck disability Index (time frame: 12 months). The study lists 4 primary outcomes in all. 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 26 Mar 2014.