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

Phase 4 Study Comparing Surigcal to Conservative Management of Type 2 Odontoid Fractures

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00283998

Enrollment

166

Registered

2006-01-31

Start date

2006-01-31

Completion date

2012-03-31

Last updated

2014-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Odontoid Fractures Type II

Keywords

Odontoid, Type II fractures, Elderly patients, Surgical vs. conservative treatment

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 \>/= 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.

Interventions

PROCEDUREsurgical versus conservative treatment

Surgical treatment of fractures versus conservative stabilization

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Proportion rate of non-union between the two treatments	6 months
Quality of life using the Neck disability Index	12 months
Quality of life using the SF-36	12 months
Proportion of bony fusion between the two treatments	6 months

Secondary

Measure	Time frame
Cervical range of motion	12 months
Identify the risk factors for a poor outcome independent of treatment intervention	12 months
Rate of complications	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026