NCT02359656

Brief Summary

The purpose of this study was to determine the clinical and radiographic long - term results in geriatric patients who had undergone surgical or non - operative treatment of odontoid non - unions, with particular regards to late bony fusion, cervical spine motion, neurological sequela, and patient's quality of life.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

7 years

First QC Date

January 31, 2015

Last Update Submit

February 4, 2015

Conditions

Odontoid Process

Outcome Measures

Primary Outcomes (1)

  • Functional outcome (range of motion) and radiographic (bony fusion) long - term results in geriatric patients who had undergone surgical or non - operative treatment of odontoid non - unions.

    follow up of at least 5 years

Secondary Outcomes (1)

  • Composite outcome measure consisting of multiple measures as late bony fusion, cervical spin, neurological sequalea

    follow up of at least 5 years

Study Arms (2)

non operative treatment

OTHER

specif non operative treatment protocol

Other: non operative treatment for odontoid non unions

operative treatment

OTHER

dorsal atlanto-axial C1-C2 Arthrodesis

Procedure: surgical treatment

Interventions

surgical treatmentPROCEDURE

C1-C1 arthrodesis

operative treatment
non operative treatment for odontoid non unionsOTHER

specific non operative treatment protocol

non operative treatment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Priv. Doz. Dr. Patrick Platzer, PhD, MBA

Study Record Dates

First Submitted

January 31, 2015

First Posted

February 10, 2015

Study Start

January 1, 2006

Primary Completion

January 1, 2013

Study Completion

January 1, 2015

Last Updated

February 10, 2015

Record last verified: 2015-02