INNOVATE Trial
Research type
Research Study
Full title
Surgical versus conservative treatment of odontoid fractures in the elderly: a prospective cohort study
IRAS ID
119797
Contact name
Jake Timothy
Contact email
Sponsor organisation
EuroSpine
Research summary
The study was an international co-operative trial in which 17 hospitals in 8 countries were involved. Patients of at least 55 years old who suffered from acute type II/III odontoid fractures and were admitted to one of the participating hospitals would be asked to participate. The study team would request the patient’s permission to collect data from their routine care to observe their outcome. The treatment that the patients would undergo would be based on the treating surgeon’s preference and would not be influenced by the study. The treatment was either surgical or conservative in nature. In case of a surgical treatment, patients would undergo an operation. In case of a conservative treatment, the patient’s neck would be externally immobilised. The primary outcome that would be assessed was a combination of fracture healing (union/stability) and favourable clinical outcome at 52 weeks after the start of the treatment.
REC name
North of Scotland Research Ethics Committee 1
REC reference
14/NS/0039
Date of REC Opinion
2 Apr 2014
REC opinion
Further Information Favourable Opinion