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A multicenter randomized controlled trial is performed in Sweden (Uppsala, Malmo and Stockholm) comparing surgery with posterior C1-C2 fusion and conservative treatment with a rigid collar. Follow up will be performed up to one year after start of treatment registering EQ5D, NDI and cervical CT scans. Mortality will be documented during follow-up. All direct and indirect costs of treatment will be registered and used for cost-effectiveness analysis.
50 patients, based on the following calculation of study size: The standard deviation for Neck Disability index, NDI, is just under 7, while "minimally clinical important difference" (MCID) is 7 points . That gives that 16 patients are needed in each group to get 80% power with a significance level of 5%. However, in the studied population the one year mortality rate is substantial, especially after a neck injury . In order to be able to draw conclusions from the study the investigators have elected to expand the study to 25 subjects in each group.
Follow up: 1w, 6w, 3m, 1y with CT, Questionaires: NDI, EQ5D. Bone density measurement at injury. Extension flexion x-ray after 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical treatment | Experimental | Stabilization of odontoid fracture with posterior fusion C1-C2 |
|
| Conservative treatment | Active Comparator | External stabilization of odontoid fracture with a rigid cervical collar for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior fusion C1-C2 | Procedure | Posterior access and screws in C1 (atlas) and C2 (axis) and fusion with addition of iliac crest bone graft. No postoperative collar. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index (NDI questionnaire) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| EQ5D questionnaire | 1 year | |
| Number of participants that deceased after inclusion | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna-Lena Robinson, MD | Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University Hospital | Uppsala | Uppsala County | 75195 | Sweden | ||
| Malmö University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Kose et al. 2007 | ||
| Background | Olerud et al. 1999 | ||
| 42274420 | Derived | Singh A, Robinson AL, Robinson Y, Rudstrom J, Lafta MS, Moller AK, Ivars K, Elmi-Terander A, MacDowall A, Olerud C, Gerdhem P. Surgical Intervention Versus Cervical Collar Treatment of Displaced Type II Odontoid Fractures in the Elderly: A Randomized Controlled Trial. Neurosurgery. 2026 Jun 11. doi: 10.1227/neu.0000000000004114. Online ahead of print. | |
| 30134944 |
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| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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|
| Rigid cervical collar | Procedure | External immobilization of cervical spine in a rigid collar for 12 weeks. |
|
|
| Malmö |
| 21428 |
| Sweden |
| Derived |
| Robinson AL, Schmeiser G, Robinson Y, Olerud C. Surgical vs. non-surgical management of displaced type-2 odontoid fractures in patients aged 75 years and older: study protocol for a randomised controlled trial. Trials. 2018 Aug 22;19(1):452. doi: 10.1186/s13063-018-2690-8. |