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Neck InjuriesNCT00266929

Treatment of Type II Odontoid Fractures Among the Elderly

An observational study of Neck Injuries and Spinal Injuries, run by AOSpine North America Research Network at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 > 64 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 64 years and olderHealthy volunteers can take part
Conditions the study is for
Neck Injuries, Spinal Injuries
What is being tested?
surgical and conservative treatment
Type of treatment
Surgery or procedure
How many people
159 participants
Where
15 sitesin 2 countries
Study dates
Dec 2005to May 2010
Phase
Observational
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 64 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Subjects receiving care for acute Type II Odontoid Fracture in participating investigational sites

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
  • Age > 64
  • Stable and unstable fractures
  • < 3 months post-injury
  • No previous treatment for an odontoid fracture

Who cannot join

  • Pathological fractures unrelated to osteoporosis
  • Severe dementia or severe mental health problems
  • Participation in other trials or unlikely to attend follow-ups

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States14 sites

  • Emory University SOM: Orthopedics

    Atlanta, Georgia, 30329

  • John Hopkins University

    Baltimore, Maryland, 21287

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Cleveland Clinic

    Cleveland, Ohio

  • Indiana Spine Group

    Indianapolis, Indiana, 46260

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Cornell Weill Medical College

    New York, New York, 10021

  • Spinal Cord Injury Center Thomas Jefferson University and The Rothman Institute

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah

    Salt Lake City, Utah, 84108

  • Harborview Medical Center

    Seattle, Washington, 98104

Other trials in United States

Canada1 site

  • Toronto Western Hospital

    Toronto, Ontario, M5T 258

Other trials in Canada

About this study

Official title: Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly

The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients > 64 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.

Read the detailed description

Hypotheses are as follows:

  • Patients receiving surgical management will exhibit better disease specific health and general health related quality of life measures compared to those managed conservatively.
  • The rate of radiographic bony fusion will be greater among elderly patients receiving surgical fixation compared to patients receiving conservative management.
  • The rate of non union will be greater in the conservative group compared to the surgical group.
  • The complication rate will be higher in the surgical group due to the nature of the intervention though the rate of severe and serious complications will be low.
Being tested
surgical, conservative treatment
Keywords
odontoid fx, surgical intervention, conservative treatment, nonunion, odontoid fractures, surgical treatment
Medical subject headings
Neck Injuries, Spinal Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surgicalProcedure or surgery

    surgical treatment of odontoid fractures

  • conservative treatmentProcedure or surgery

    conservative stabilization of fractures

Study groups in NCT00266929
Study groupRoleWhat they receive
SurgicalSubjects receiving surgical treatment for Type II odontoid fracture per discretion of investigator (non-randomized allocation)
Receives: Procedure: surgical
Non-surgicalSubjects treated with non-operative treatment options
Receives: Procedure: conservative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index

    Measured: 12 months

  2. Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients

    Measured: 12 months

  3. Compare the rate of non-union between the surgically and conservatively managed patients

    Measured: 12 months

Secondary outcomes (3)

  1. Compare the rate of complications

    Measured: 12 months

  2. Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management

    Measured: 12 months

  3. Identify 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.

  1. First posted20 Dec 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00266929
Sponsor's protocol ID
07-GOF-05
Status last verified
Aug 2017
First submitted
19 Dec 2005
Last updated
11 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • Smith HE, Kerr SM, Maltenfort M, Chaudhry S, Norton R, Albert TJ, Harrop J, Hilibrand AS, Anderson DG, Kopjar B, Brodke DS, Wang JC, Fehlings MG, Chapman JR, Patel A, Arnold PM, Vaccaro AR. Early complications of surgical versus conservative treatment of isolated type II odontoid fractures in octogenarians: a retrospective cohort study. J Spinal Disord Tech. 2008 Dec;21(8):535-9. doi: 10.1097/BSD.0b013e318163570b.

    PubMed 19057244

  • Smith HE, Vaccaro AR, Maltenfort M, Albert TJ, Hilibrand AS, Anderson DG, Harrop J, Fehlings MG, Kopjar B, Brodke DS, Arnold PM, Shaffrey CI. Trends in surgical management for type II odontoid fracture: 20 years of experience at a regional spinal cord injury center. Orthopedics. 2008 Jul;31(7):650.

    PubMed 19292388

  • Vaccaro AR, Kepler CK, Kopjar B, Chapman J, Shaffrey C, Arnold P, Gokaslan Z, Brodke D, France J, Dekutoski M, Sasso R, Yoon ST, Bono C, Harrop J, Fehlings MG. Functional and quality-of-life outcomes in geriatric patients with type-II dens fracture. J Bone Joint Surg Am. 2013 Apr 17;95(8):729-35. doi: 10.2106/JBJS.K.01636.

    PubMed 23595072

  • Fehlings MG, Arun R, Vaccaro AR, Arnold PM, Chapman JR, Kopjar B. Predictors of treatment outcomes in geriatric patients with odontoid fractures: AOSpine North America multi-centre prospective GOF study. Spine (Phila Pa 1976). 2013 May 15;38(11):881-6. doi: 10.1097/BRS.0b013e31828314ee.

    PubMed 23459135

  • Chapman J, Smith JS, Kopjar B, Vaccaro AR, Arnold P, Shaffrey CI, Fehlings MG. The AOSpine North America Geriatric Odontoid Fracture Mortality Study: a retrospective review of mortality outcomes for operative versus nonoperative treatment of 322 patients with long-term follow-up. Spine (Phila Pa 1976). 2013 Jun 1;38(13):1098-104. doi: 10.1097/BRS.0b013e318286f0cf.

    PubMed 23354104

  • Smith HE, Kerr SM, Fehlings MG, Chapman J, Maltenfort M, Zavlasky J, Harris E, Albert TJ, Harrop J, Hilibrand AS, Anderson DG, Vaccaro AR. Trends in epidemiology and management of type II odontoid fractures: 20-year experience at a model system spine injury tertiary referral center. J Spinal Disord Tech. 2010 Dec;23(8):501-5. doi: 10.1097/BSD.0b013e3181cc43c7.

    PubMed 20940632

  • Smith JS, Kepler CK, Kopjar B, Harrop JS, Arnold P, Chapman JR, Fehlings MG, Vaccaro AR, Shaffrey CI. Effect of type II odontoid fracture nonunion on outcome among elderly patients treated without surgery: based on the AOSpine North America geriatric odontoid fracture study. Spine (Phila Pa 1976). 2013 Dec 15;38(26):2240-6. doi: 10.1097/BRS.0000000000000009.

    PubMed 24335630

Questions about this trial

What is this clinical trial studying?

An observational study of Neck Injuries and Spinal Injuries, run by AOSpine North America Research Network at 15 sites in 2 countries.

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 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Canada. 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.

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?

Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00266929, which also lists 7 linked publications.

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 11 Aug 2017.

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