Clinical trial NCT02789774: Uppsala Study on Odontoid Fracture Treatment in the Elderly
Official title: Randomised Controlled Trial on Surgical vs Non-surgical Treatment of Type II Odontoid Fracture Treatment in the Elderly
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Fractures
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Acute displaced odontoid fracture type II according to Anderson and D'Alonzo, age 75 years or older. Displacement defined as 4 mm anterior translator displacement, any posterior translator displacement, or 10 degrees of angulation.

Exclusion Criteria:

* Any contraindication to surgery, anesthesia class ASA 4 or higher (Saklad 1941), severe senile dementia (defined as being admitted to a nursing home or hospital because of the dementia), anatomical or other prerequisites that makes an operation unsuitable.

Primary outcomes:
measure: Neck Disability Index (NDI questionnaire)
timeFrame: 1 year
Secondary outcomes:
measure: EQ5D questionnaire
timeFrame: 1 year
measure: Number of participants that deceased after inclusion
timeFrame: 1 year
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
state: Uppsala County
city: Malmö
country: Sweden
facility: Malmö University Hospital
Study officials:
affiliation: Uppsala University Hospital
name: Anna-Lena Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kose et al. 2007
citation: Olerud et al. 1999
citation: 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.