The goal of this prospective cohort study is to assess fracture union/stability and clinical outcome after surgical and conservative treatments of type II/III odontoid fractures in the elderly patient (>=55 years). The general presumption is that…
ID
Source
Brief title
Condition
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Clinical outcome, scored by the Neck Disability Index at 52 weeks after start
of treatment
- Fracture healing, assessing union (union or non-union) and stability at 52
weeks after start of treatment
Union will be defined by evidence of bone trabeculae crossing the fracture site
and absence of sclerotic borders adjacent to the fracture site, assessed using
computed tomography (CT).
Fracture stability will be assessed using cervical dynamic X-rays in lateral
projection. A maximum of 2 mm movement at the fracture site is considered
stable.
Imaging data will be sent to the coordinating centre and will be judged by
independent assessors (neuroradiologists) who are blinded to the results.
Secondary outcome
Clinical: Myelopathy Disability Index, VAS neck pain score, SF-36, EQ5D, DS14
(psychometric properties), IPQ-K (illness perception), Likert
Radiological: Fracture displacement, grade of osteoporosis in C2, grade of
degeneration of C1-C2 facet joints, pseudoarthrosis
General: Complications, reinterventions (secondary surgery, surgery after
failed conservative treatment)
Background summary
Odontoid fractures are the most common cervical spine injuries in elderly
patients and their prevalence is expected to increase. The choice between
surgical or conservative treatment for patients of this age group is still
controversial. No consensus exists as to whether the goal of treatment should
be osseous union, fracture stability or clinical outcome and how outcome should
be measured. A recent review of the available literature could not yet identify
the optimal treatment.
Study objective
The goal of this prospective cohort study is to assess fracture union/stability
and clinical outcome after surgical and conservative treatments of type II/III
odontoid fractures in the elderly patient (>=55 years). The general presumption
is that a surgical intervention is generally technically successful, since it
leads to a stable cervical spine. However, the condition of the patient may
deteriorate through undergoing cervical spine surgery. Therefore, especially in
the very old patient (>=80 years of age) a conservative treatment is often
proposed to avoid the complications that may accompany spine surgery. This may
lead to non-union, but if the cervical spine is stable, this does not
necessarily lead to secondary surgery. The outcome parameter, union, that is
often used in literature, may thus not accurately reflect the clinical
situation and its consequences. Debate remains as to whether non-union can lead
to complaints in the patient.
A study in which the clinical condition of both surgically and conservatively
treated patients is well monitored, as well as their radiological condition,
both reviewing union and stability, may lead to better decisions in odontoid
fractures in the elderly. Ideally the subgroup analysis may offer prognostic
factors that can predict the success of either a surgical or conservative
treatment.
Study design
A prospective, comparative cohort study with two parallel groups is to be
carried out. Patients suffering from acute type II and III odontoid fractures
and who are over 55 years of age will be included. A multicenter study is
necessary to include the required number of patients in the proposed time
frame. All participating hospitals are individually responsible for the
treatment applied. At admission and follow-up moments, patients will be seen by
their treating physician.
Based on the treating surgeon*s decision, surgical or conservative treatment
will be started and documented. During follow-up appointments, demographic,
radiological and clinical data will be gathered. Patients will also be sent
questionnaires to complete at home. Questionnaires will focus on pain
intensity, general wellbeing, perceived recovery and illness-related
inconveniences.
Study burden and risks
Participating in the study will not pose additional risks. Patients will be
askes to complete questionnaires.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- At least 55 years old
- Acute type II and III odontoid fracture according to Anderson and d*Alonzo
classification (possibly in combination with other fractures); diagnosed using
computed tomography
- Less than two weeks after injury
- Informed consent
Exclusion criteria
- Rheumatoid arthritis
- Ankylosing spondylitis
- Previous treatment for odontoid fracture
- Communication with patient is hampered (e.g. language barrier, severe
cognitive impairment, coma)
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL39744.058.12 |
| OMON | NL-OMON25295 |