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

• ClinicalTrials.gov Identifier: NCT03788200
• Recruitment Status: Enrolling by invitation
• First Posted: December 27, 2018
• Last Update Posted: December 27, 2018
• Sponsor: Rothman Institute Orthopaedics
• Information provided by (Responsible Party): Rothman Institute Orthopaedics

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Odontoid Fracture	Procedure: Bracing; Procedure: posterior C1-C2 instrumented fusion	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly
• Actual Study Start Date: June 14, 2018
• Estimated Primary Completion Date: October 2020
• Estimated Study Completion Date: October 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Procedure: 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.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. neck disability [ Time Frame: 6 months post randomization ]
   Measured by validated outcome measure NDI (Neck Disability Index)

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

Rothman Institute

Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

More Information

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT03788200 History of Changes
• Other Study ID Numbers: 2018Kepler
• First Posted: December 27, 2018
• Last Update Posted: December 27, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Fractures, Bone; Wounds and Injuries