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

NCT ID: NCT03788200

Last Updated: 2018-12-28

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-14

Study Completion Date

2020-10-31

Brief Summary

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This prospective study addresses one of the most controversial topics in the treatment of cervical spine trauma: the management of type II odontoid process fractures in the elderly. It is the hypothesis that surgical treatment will result in improved functional outcome measures, neck pain and mortality rates as compared with nonsurgical management. Furthermore, it is hypothesized that surgical treatment of odontoid process fractures will limit hospital re-admissions and development of medical complications secondary to prolonged immobilization in a cervical orthosis and delayed surgery related to late fracture displacement, which are often associated with non-operative care. Additionally, data from this study will be useful in identifying patient-specific predictors of improved outcome which can be used to optimize treatment algorithms and more effectively counsel patients who sustain these injuries.

Detailed Description

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Conditions

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Odontoid Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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post-injury bracing with rigid cervical collar

Treatment arm #1 (8 weeks of post-injury bracing with rigid cervical collar): Participants randomized to this treatment arm will be treated with 8 weeks in a rigid cervical collar.

Group Type ACTIVE_COMPARATOR

Bracing

Intervention Type PROCEDURE

Treatment arm #1 (8 weeks of post-injury bracing with rigid cervical collar): Participants randomized to this treatment arm will be treated with 8 weeks in a rigid cervical collar.

posterior C1-2 instrumented fusion

Participants randomized to this treatment arm will undergo posterior C1-2 instrumented fusion with either local bone grafting or autologous iliac crest bone grafting with or without allograft bone grafting. Bone grafting decision will be made by the treating surgeon. All remaining decisions surrounding medical and surgical care will be made by the attending spine surgeon involved in each case.

Group Type ACTIVE_COMPARATOR

posterior C1-C2 instrumented fusion

Intervention Type PROCEDURE

Treatment arm #2 (posterior C1-2 instrumented fusion): Participants randomized to this treatment arm will undergo posterior C1-2 instrumented fusion with either local bone grafting or autologous iliac crest bone grafting with or without allograft bone grafting. Bone grafting decision will be made by the treating surgeon. All remaining decisions surrounding medical and surgical care will be made by the attending spine surgeon involved in each case.

Interventions

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Bracing

Treatment arm #1 (8 weeks of post-injury bracing with rigid cervical collar): Participants randomized to this treatment arm will be treated with 8 weeks in a rigid cervical collar.

Intervention Type PROCEDURE

posterior C1-C2 instrumented fusion

Treatment arm #2 (posterior C1-2 instrumented fusion): Participants randomized to this treatment arm will undergo posterior C1-2 instrumented fusion with either local bone grafting or autologous iliac crest bone grafting with or without allograft bone grafting. Bone grafting decision will be made by the treating surgeon. All remaining decisions surrounding medical and surgical care will be made by the attending spine surgeon involved in each case.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients to be considered for trial enrollment will include those:

1. ages 65 and older;
2. presenting with type II odontoid fracture confirmed by CT scan to one of the study centers;
3. deemed appropriate by the attending surgeon involved for C1-2 posterior cervical fusion procedure if surgical management were to be indicated
4. able to independently cooperate in the completion of all study consents, forms and documents.
5. able to speak, read and write English at an elementary school level

Exclusion Criteria

Patients to be excluded from trial enrolment include:

1. those with previously documented type II odontoid fracture;
2. those with odontoid fracture related to malignancy or infection;
3. those with associated spinal cord injury
4. those with other cervical, thoracic or lumbar injuries requiring surgical intervention
5. those with aberrant/anomalous local anatomy which precludes posterior placement of C1/2 instrumentation
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2018Kepler

Identifier Type: -

Identifier Source: org_study_id