Uppsala Study on Odontoid Fracture Treatment in the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Survival After Surgical Treatment of Axis Fractures in Elderly

NCT02839057

Spinal Fractures

COMPLETED

Study on Orthosis in Cervical Spine Fracture Treatment

NCT06848660

Cervical Spine Fractures Cervical Spine Injury Rigid Collar

NOT_YET_RECRUITING NA

Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly

NCT03788200

Odontoid Fracture

UNKNOWN NA

Anterior Odontoid Screw Osteosynthesis in Treatment of Type 2 Odontoid Fracture

NCT03355703

Odontoid Fracture

COMPLETED

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

NCT06961578

Odontoid Fracture Elderly

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgical treatment

Stabilization of odontoid fracture with posterior fusion C1-C2

Group Type EXPERIMENTAL

Posterior fusion C1-C2

Intervention Type PROCEDURE

Posterior access and screws in C1 (atlas) and C2 (axis) and fusion with addition of iliac crest bone graft. No postoperative collar.

Conservative treatment

External stabilization of odontoid fracture with a rigid cervical collar for 3 months.

Group Type ACTIVE_COMPARATOR

Rigid cervical collar

Intervention Type PROCEDURE

External immobilization of cervical spine in a rigid collar for 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Posterior fusion C1-C2

Posterior access and screws in C1 (atlas) and C2 (axis) and fusion with addition of iliac crest bone graft. No postoperative collar.

Intervention Type PROCEDURE

Rigid cervical collar

External immobilization of cervical spine in a rigid collar for 12 weeks.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Posterior atlantoaxial fusion cervical orthosis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No