|- candidate number||13367|
|- NTR Number||NTR3630|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-sep-2012|
|- Secondary IDs||39744 ABR|
|- Public Title||The optimal treatment of odontoid fractures in the elderly: A prospective study.|
|- Scientific Title||Surgical versus conservative treatment of odontoid fractures in the elderly: A prospective cohort study.|
|- ACRONYM||INNOVATE Trial|
|- hypothesis||Odontoid fractures are the most common cervical spine fractures in the elderly. However, the optimal treatment of this condition is still subject to controversy. The goal of this study is to assess fracture union/stability and clinical outcome after surgical and conservative treatments for odontoid fractures in the elderly.|
|- Healt Condition(s) or Problem(s) studied||Odontoid fractures, Older adults|
|- Inclusion criteria||1. At least 55 years old;|
2. Acute type II and III odontoid fracture based on the Anderson and d’Alonzo classification; diagnosed using CT;
3. Less than two weeks post injury;
4. Informed consent.
|- Exclusion criteria||1. Systemic co-morbidity that might influence outcome (e.g. R.A.);|
2. Previous treatment for odontoid fracture;
3. Existence of a serious language barrier.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||23-aug-2012|
|- planned closingdate||23-aug-2016|
|- Target number of participants||275|
|- Interventions||1. Surgical treatment (anterior odontoid screw fixation or posterior cervical fusion);|
2. Conservative treatment (cervical collar or halo traction).
|- Primary outcome||1. Osseous union;|
2. Fracture stability;
3. Clinical outcome (NDI).
|- Secondary outcome||1. MDI;|
2. VAS neck pain score;
7. Fracture gap;
8. Fracture angulation;
9. Grade of osteoporosis in C2;
10. Grading of degeneration in C0-C2 joints;
12. Secondary interventions.
|- Timepoints||Follow-up moments are scheduled at 6, 12, 26, 52 and 104 weeks after the start of treatment.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| J.G.J. Huybregts|
|- CONTACT for SCIENTIFIC QUERIES|| J.G.J. Huybregts|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Patients meeting the inclusion criteria will be asked to participate. The treatment will be based on the treating surgeon's preference and can be either surgical or conservative. The goal of this study is to assess fracture union/stability and clinical outcome after the different treatments.
Seventeen centres from eight different countries have agreed to participate (The Netherlands, Austria, Germany, Spain, United Kingdom, Sweden, Belgium, Italy).|
|- Main changes (audit trail)||11-Apr-2013: New inclusion- and exclusion criteria - NM|
1. ≥ 55 years old;
2. Acute type II or III odontoid fracture according to Anderson and d’Alonzo classification (possibly in combination with other fractures); diagnosed using CT;
3. Less than two weeks after injury;
4. Informed consent.
1. Rheumatoid arthritis;
2. Ankylosing spondylitis;
3. Previous treatment for odontoid fracture;
4. Communication with patient is hampered (e.g. language barrier, severe cognitive impairment, coma).
New planned start- and closingdate are: 01-08-2012 and 01-08-2017.
|- RECORD||25-sep-2012 - 11-apr-2013|