Treatment of Type II Odontoid Fractures Among the Elderly

Spinal Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266929
• Other study ID #: 07-GOF-05
• Status: Completed
• Phase: N/A
• First received: December 19, 2005
• Last updated: August 9, 2017
• Start date: December 2005
• Est. completion date: May 2010

Study information

• Verified date: August 2017
• Source: AOSpine North America Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 fractures.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 64 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pathological fractures unrelated to osteoporosis

• Severe dementia or severe mental health problems

• Participation in other trials or unlikely to attend follow-ups

Related Conditions & MeSH terms

• Neck Injuries
• Spinal Injuries
• Wounds and Injuries

Intervention

Procedure:
• surgical
surgical treatment of odontoid fractures
• conservative treatment
conservative stabilization of fractures

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario
United States	Emory University SOM: Orthopedics	Atlanta	Georgia
United States	John Hopkins University	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	Indiana Spine Group	Indianapolis	Indiana
United States	Kansas University Medical Center	Kansas City	Kansas
United States	West Virginia University	Morgantown	West Virginia
United States	Vanderbilt University	Nashville	Tennessee
United States	Cornell Weill Medical College	New York	New York
United States	Spinal Cord Injury Center Thomas Jefferson University and The Rothman Institute	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
AOSpine North America Research Network	AOSpine North America

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (7)

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 — View Citation

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. do — View Citation

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 inju — View Citation

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. — View Citation

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. — View Citation

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 odon — View Citation

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 Bon — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index		12 months
Primary	Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients		12 months
Primary	Compare the rate of non-union between the surgically and conservatively managed patients		12 months
Secondary	Compare the rate of complications		12 months
Secondary	Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management		12 months
Secondary	Identify risk factors for a poor outcome, independent of treatment intervention		12 months