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

NCT03788200 | Unknown

• 1 other identifier: 2018Kepler
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Odontoid Fracture

Outcome Measures

Primary Outcomes (1)

• neck disability

  Measured by validated outcome measure NDI (Neck Disability Index)

  6 months post randomization

Study Arms (2)

post-injury bracing with rigid cervical collar

ACTIVE COMPARATOR

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.

Procedure: Bracing

posterior C1-2 instrumented fusion

ACTIVE COMPARATOR

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.

Procedure: posterior C1-C2 instrumented fusion

Interventions

Bracing 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.

post-injury bracing with rigid cervical collar

posterior C1-C2 instrumented fusion 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.

posterior C1-2 instrumented fusion

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients to be excluded from trial enrolment include:
• those with previously documented type II odontoid fracture;
• those with odontoid fracture related to malignancy or infection;
• those with associated spinal cord injury
• those with other cervical, thoracic or lumbar injuries requiring surgical intervention
• those with aberrant/anomalous local anatomy which precludes posterior placement of C1/2 instrumentation

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Braces

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 27, 2018
• Study Start: June 14, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: December 28, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)