Odontoid fractures are the most common cervical spine fractures in the elderly. However, the optimal treatment of this condition is still subject to controversy. The goal of this study is to assess fracture union/stability and clinical outcome after…
ID
Source
Brief title
Condition
- Nervous system, skull and spine therapeutic procedures
Synonym
Health condition
Odontoid fractures in the elderly
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Osseous union;
2. Fracture stability;
3. Clinical outcome (NDI).
Secondary outcome
1. MDI;
2. VAS neck pain score;
3. SF-36;
4. EQ5D;
5. DS14;
6. IPQ-K;
7. Fracture gap;
8. Fracture angulation;
9. Grade of osteoporosis in C2;
10. Grading of degeneration in C0-C2 joints;
11. Complications;
12. Secondary interventions.
Background summary
Patients meeting the inclusion criteria will be asked to participate. The treatment will be based on the treating surgeon's preference and can be either surgical or conservative. The goal of this study is to assess fracture union/stability and clinical outcome after the different treatments. Seventeen centres from eight different countries have agreed to participate (The Netherlands, Austria, Germany, Spain, United Kingdom, Sweden, Belgium, Italy).
Study objective
Odontoid fractures are the most common cervical spine fractures in the elderly. However, the optimal treatment of this condition is still subject to controversy. The goal of this study is to assess fracture union/stability and clinical outcome after surgical and conservative treatments for odontoid fractures in the elderly.
Study design
Follow-up moments are scheduled at 6, 12, 26, 52 and 104 weeks after the start of treatment.
Intervention
1. Surgical treatment (anterior odontoid screw fixation or posterior cervical fusion);
2. Conservative treatment (cervical collar or halo traction).
Leiden University Medical Centre<br>
PO box 9600
J.G.J. Huybregts
Leiden 2300 RC
The Netherlands
-
j.g.j.huybregts@lumc.nl
Leiden University Medical Centre<br>
PO box 9600
J.G.J. Huybregts
Leiden 2300 RC
The Netherlands
-
j.g.j.huybregts@lumc.nl
Age
Inclusion criteria
11-04-2013: New inclusion criteria: 1. ≥ 55 years old;
2. Acute type II or III odontoid fracture according to Anderson and d’Alonzo classification (possibly in combination with other fractures); diagnosed using CT;
3. Less than two weeks after injury;
4. Informed consent.
Exclusion criteria
11-04-2013: New exclusion criteria: 1. Rheumatoid arthritis;
2. Ankylosing spondylitis;
3. Previous treatment for odontoid fracture;
4. Communication with patient is hampered (e.g. language barrier, severe cognitive impairment, coma).
Design
Recruitment
IPD sharing statement
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3337 |
| NTR-old | NTR3630 |
| CCMO | NL39744.058.12 |
| OMON | NL-OMON50404 |