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 range

65 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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