CompletedPhase 4

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

United States166 participantsStarted 2006-01

Plain-language 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.

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Quality of life using the Neck disability Index

Timeframe: 12 months

Quality of life using the SF-36

Timeframe: 12 months

Proportion of bony fusion between the two treatments

Timeframe: 6 months

Proportion rate of non-union between the two treatments

Timeframe: 6 months

Trial details

NCT IDNCT00283998

SponsorAO Clinical Investigation and Publishing Documentation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-10

View on ClinicalTrials.gov More Odontoid Fractures Type II trials