Treatment of Type II Odontoid Fractures Among the Elderly

NCT00266929 | Completed

• 1 other identifier: 07-GOF-05
• Study Type: observational
• Target: 159
• Locations: 2 countries
• Sites: 15

Brief 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.

Conditions

Neck Injuries; Spinal Injuries

Keywords

odontoid fx; surgical intervention; conservative treatment; nonunion; odontoid fractures; surgical treatment

Outcome Measures

Primary Outcomes (3)

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

  12 months

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

  12 months

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

  12 months

Secondary Outcomes (3)

• Compare the rate of complications

  12 months

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

  12 months

• Identify risk factors for a poor outcome, independent of treatment intervention

  12 months

Study Arms (2)

Surgical

Subjects receiving surgical treatment for Type II odontoid fracture per discretion of investigator (non-randomized allocation)

Procedure: surgical

Non-surgical

Subjects treated with non-operative treatment options

Procedure: conservative treatment

Interventions

surgical PROCEDURE

surgical treatment of odontoid fractures

Surgical

conservative treatment PROCEDURE

conservative stabilization of fractures

Non-surgical

Eligibility Criteria

• Age: 64 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AOSpine North America Research Network: lead
• AOSpine North America: collaborator

Study Sites (15)

Emory University SOM: Orthopedics

Atlanta, Georgia, 30329, United States

Location

Indiana Spine Group

Indianapolis, Indiana, 46260, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

John Hopkins University

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cornell Weill Medical College

New York, New York, 10021, United States

Location

Cleveland Clinic

Cleveland, Ohio, United States

Location

Spinal Cord Injury Center Thomas Jefferson University and The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Toronto Western Hospital

Toronto, Ontario, M5T 258, Canada

Location

Related Publications (7)

• 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.

  PMID: 19057244 BACKGROUND

• 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.

  PMID: 19292388 BACKGROUND

• 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.

  PMID: 23595072 RESULT

• 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.

  PMID: 23459135 RESULT

• 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.

  PMID: 23354104 RESULT

• 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.

  PMID: 20940632 RESULT

• 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.

  PMID: 24335630 RESULT

MeSH Terms

Conditions

Neck Injuries; Spinal Injuries

Interventions

Surgical Procedures, Operative; Conservative Treatment

Condition Hierarchy (Ancestors)

Wounds and Injuries; Back Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Alexander R Vaccaro, MD

  Thomas Jefferson University and The Rothman Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2005
• First Posted: December 20, 2005
• Study Start: December 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

CA (1); US (14)