SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70

Condition(s) studied

Investigational drug(s) / intervention(s)

C1-2 instrumentation: Surgical fracture stabilization with a posterior screw-rod system from C1-2 from a posterior approach. The routine surgery commonly lasts approximately 100 minutes and requires a hospital stay of about 6 days. An additional external bracing in the postoperative setting is not required.

External immobilization with rigid cervical collar: External immobilization with a rigid cervical collar for 12 weeks. Compliance is monitored through patient diaries, recognizing the real-world challenges of consistent brace use. Lack of adherence is considered to reflect routine clinical practice. A typical drawback of the conservative intervention in daily practice is the absolute reliance on patient compliance to wear the collar continuously for at least 12 weeks, which poses a significant challenge to this treatment strategy.

Study summary

The goal of this clinical trial is to compare two treatment options-surgery or rigid collar bracing-for unstable neck fractures (odontoid fractures) in adults aged 70 years and older. These fractures are common in older adults and can significantly impact mobility, independence, and quality of life. There is currently no clear evidence to determine which treatment is better for this population. The main questions it aims to answer are:

* Does surgery or conservative collar treatment lead to better improvement in daily living, measured by the Barthel Index, after 12 weeks?
* What are the differences in pain, disability, and quality of life between the two treatments?

The study team will compare patients who receive surgical stabilization with those who are treated with a rigid cervical collar to see which approach supports better functional outcomes and healing.

Participants will:

* be randomly assigned to either surgery (posterior C1-C2 screw-rod fixation) or conservative collar treatment
* attend study visits at 12 weeks and 6 months
* complete questionnaires on daily functioning, pain, and quality of life
* undergo CT scans and other medical assessments
* record collar use (for conservative group) in a diary
* be monitored for any complications or changes in treatment (including crossover to surgery if needed)

The study aims to include 322 participants to provide evidence on which treatment helps older adults recover better from odontoid fractures with fewer complications and improved quality of life.

Eligibility

Primary outcome measure(s)

• Barthel Index — Baseline to 12 weeks
  Change in Barthel Index (BI) between baseline and 12 weeks thereafter

Trial sites (16)

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