Spinal FracturesUSOFTNCT02789774
Uppsala Study on Odontoid Fracture Treatment in the Elderly
A study testing Posterior fusion C1-C2 and Rigid cervical collar in people with Spinal Fractures, run by Uppsala University at 2 sites in Sweden.
Trial summary
A multicenter randomized controlled trial is performed in Sweden (Uppsala, Malmo and Stockholm) comparing surgery with posterior C1-C2 fusion and conservative treatment with a rigid collar. Follow up will be performed up to one year after start of treatment registering EQ5D, NDI and cervical CT scans. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Spinal Fractures
- What is being tested?
- Posterior fusion C1-C2 and Rigid cervical collar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSweden
- Study dates
- Feb 2012to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Acute displaced odontoid fracture type II according to Anderson and D'Alonzo, age 75 years or older. Displacement defined as 4 mm anterior translator displacement, any posterior translator displacement, or 10 degrees of angulation.
Who cannot join
- Any contraindication to surgery, anesthesia class ASA 4 or higher (Saklad 1941), severe senile dementia (defined as being admitted to a nursing home or hospital because of the dementia), anatomical or other prerequisites that makes an operation unsuitable.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Malmö University Hospital
Malmö, 21428
Uppsala University Hospital
Uppsala, Uppsala County, 75195
About this study
Official title: Randomised Controlled Trial on Surgical vs Non-surgical Treatment of Type II Odontoid Fracture Treatment in the Elderly
A multicenter randomized controlled trial is performed in Sweden (Uppsala, Malmo and Stockholm) comparing surgery with posterior C1-C2 fusion and conservative treatment with a rigid collar. Follow up will be performed up to one year after start of treatment registering EQ5D, NDI and cervical CT scans. Mortality will be documented during follow-up. All direct and indirect costs of treatment will be registered and used for cost-effectiveness analysis.
Read the detailed description
50 patients, based on the following calculation of study size: The standard deviation for Neck Disability index, NDI, is just under 7, while "minimally clinical important difference" (MCID) is 7 points . That gives that 16 patients are needed in each group to get 80% power with a significance level of 5%. However, in the studied population the one year mortality rate is substantial, especially after a neck injury . In order to be able to draw conclusions from the study the investigators have elected to expand the study to 25 subjects in each group.
Follow up: 1w, 6w, 3m, 1y with CT, Questionaires: NDI, EQ5D. Bone density measurement at injury. Extension flexion x-ray after 1 year.
- Conditions
- Spinal Fractures
- Being tested
- Posterior fusion C1-C2, Rigid cervical collar
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior fusion C1-C2Procedure or surgery
Also called Posterior atlantoaxial fusion
Posterior access and screws in C1 (atlas) and C2 (axis) and fusion with addition of iliac crest bone graft. No postoperative collar.
Rigid cervical collarProcedure or surgery
Also called cervical orthosis
External immobilization of cervical spine in a rigid collar for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Experimental | Stabilization of odontoid fracture with posterior fusion C1-C2 Receives: Procedure: Posterior fusion C1-C2 |
| Conservative treatment | Active comparator | External stabilization of odontoid fracture with a rigid cervical collar for 3 months. Receives: Procedure: Rigid cervical collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index (NDI questionnaire)
Measured: 1 year
Secondary outcomes (2)
EQ5D questionnaire
Measured: 1 year
Number of participants that deceased after inclusion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startFeb 2012
- Primary completionMar 2024
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal FracturesStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna-Lena Robinson, MD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789774
- Sponsor's protocol ID
- USOFT
- Acronym
- USOFT
- Status last verified
- Mar 2024
- First submitted
- 25 Aug 2015
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kose et al. 2007
Olerud et al. 1999
Singh A, Robinson AL, Robinson Y, Rudstrom J, Lafta MS, Moller AK, Ivars K, Elmi-Terander A, MacDowall A, Olerud C, Gerdhem P. Surgical Intervention Versus Cervical Collar Treatment of Displaced Type II Odontoid Fractures in the Elderly: A Randomized Controlled Trial. Neurosurgery. 2026 Jun 11. doi: 10.1227/neu.0000000000004114. Online ahead of print.
PubMed 42274420Robinson AL, Schmeiser G, Robinson Y, Olerud C. Surgical vs. non-surgical management of displaced type-2 odontoid fractures in patients aged 75 years and older: study protocol for a randomised controlled trial. Trials. 2018 Aug 22;19(1):452. doi: 10.1186/s13063-018-2690-8.
PubMed 30134944
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial on Surgical vs Non-surgical Treatment of Type II Odontoid Fracture Treatment in the Elderly
- ClinicalTrials.gov ID
- NCT02789774
- Acronym / sponsor ID
- USOFT / USOFT
- Conditions
- Spinal Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Mar 2024 (actual)
- Study completion
- Jun 2024 (estimated)
- First posted
- 3 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter randomized controlled trial is performed in Sweden (Uppsala, Malmo and Stockholm) comparing surgery with posterior C1-C2 fusion and conservative treatment with a rigid collar. Follow up will be performed up to one year after start of treatment registering EQ5D, NDI and cervical CT scans. Mortality will be documented during follow-up. All direct and indirect costs of treatment will be registered and used for cost-effectiveness analysis.
Detailed description
50 patients, based on the following calculation of study size: The standard deviation for Neck Disability index, NDI, is just under 7, while "minimally clinical important difference" (MCID) is 7 points . That gives that 16 patients are needed in each group to get 80% power with a significance level of 5%. However, in the studied population the one year mortality rate is substantial, especially after a neck injury . In order to be able to draw conclusions from the study the investigators have elected to expand the study to 25 subjects in each group.
Follow up: 1w, 6w, 3m, 1y with CT, Questionaires: NDI, EQ5D. Bone density measurement at injury. Extension flexion x-ray after 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | Experimental | Procedure: Posterior fusion C1-C2Stabilization of odontoid fracture with posterior fusion C1-C2 |
| Conservative treatment | Active comparator | Procedure: Rigid cervical collarExternal stabilization of odontoid fracture with a rigid cervical collar for 3 months. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Acute displaced odontoid fracture type II according to Anderson and D'Alonzo, age 75 years or older. Displacement defined as 4 mm anterior translator displacement, any posterior translator displacement, or 10 degrees of angulation.
Key exclusion criteria (1 listed)
- Any contraindication to surgery, anesthesia class ASA 4 or higher (Saklad 1941), severe senile dementia (defined as being admitted to a nursing home or hospital because of the dementia), anatomical or other prerequisites that makes an operation unsuitable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior fusion C1-C2Also: Posterior atlantoaxial fusionPosterior access and screws in C1 (atlas) and C2 (axis) and fusion with addition of iliac crest bone graft. No postoperative collar. | Procedure or surgery | Surgical treatment |
| Rigid cervical collarAlso: cervical orthosisExternal immobilization of cervical spine in a rigid collar for 12 weeks. | Procedure or surgery | Conservative treatment |
Primary outcome
Neck Disability Index (NDI questionnaire)
Time frame: 1 year
2 secondary outcomes
EQ5D questionnaire
Time frame: 1 year
Number of participants that deceased after inclusion
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- BackgroundKose et al. 2007
- BackgroundOlerud et al. 1999
- Derived from this study: PubMed 42274420Singh A, Robinson AL, Robinson Y, Rudstrom J, Lafta MS, Moller AK, Ivars K, Elmi-Terander A, MacDowall A, Olerud C, Gerdhem P. Surgical Intervention Versus Cervical Collar Treatment of Displaced Type II Odontoid Fractures in the Elderly: A Randomized Controlled Trial. Neurosurgery. 2026 Jun 11. doi: 10.1227/neu.0000000000004114. Online ahead of print.
- Derived from this study: PubMed 30134944Robinson AL, Schmeiser G, Robinson Y, Olerud C. Surgical vs. non-surgical management of displaced type-2 odontoid fractures in patients aged 75 years and older: study protocol for a randomised controlled trial. Trials. 2018 Aug 22;19(1):452. doi: 10.1186/s13063-018-2690-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna-Lena Robinson, MD principal investigator
Uppsala University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior fusion C1-C2 and Rigid cervical collar in people with Spinal Fractures, run by Uppsala University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (NDI questionnaire) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02789774, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.