Spine FractureORNOTNCT03097081
ORthosis vs No Orthosis After Surgically Treated Traumatic Thoracolumbar Fractures
A study testing No orthosis and Orthosis in people with Spine Fracture and Orthosis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Rationale: There is no evidence in the current literature regarding the additional value of an orthosis after surgically treated thoracolumbar spine fractures. Objective: To assess whether an orthosis provides additional pain relief compared to no orthosis after posteriorly fixated thoracolumbar spine fractures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spine Fracture, Orthosis, Traumatic Fracture
- What is being tested?
- No orthosis and Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2016to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years
- Traumatic thoracolumbar spine fracture from thoracic 7 - lumbar 4
- AO fracture types A-C
- Undergoing surgical dorsal fixation for fracture
Who cannot join
- Inadequate knowledge of Dutch language or to fill in questionnaire
- Complete or partial spinal cord injury (ASIA A to D)
- (Additional) anterior surgical stabilization
- Thoracolumbar fracture of other aetiology than traumatic, e.g. pathologic, infectious
- Not able to walk before fracturing vertebra
- Unable to come to the outpatient clinic (e.g. residing outside the Netherlands)
Show all 14Show fewer
- Injury Severity Score (ISS) ≥ 16
- Brain injury with Abbreviated Injury Score (AIS) ≥ 4
- Solitary Lumbar 5 fracture
- Inability to wear an orthosis, most probable reasons:
- BMI > 35
- Thoraco-abdominal wounds (through trauma or secondary from surgery) on places at which the orthosis contacts the body so aggravation of pain or chances of infection increase significantly.
- 12 of 27
- Pre-existing spine deformities (scoliosis or very severe kyphosis/lordosis) which impair the use of the orthosis or aggravate pain.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
AJ Smits, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
VU University medical center
Amsterdam, North Holland, 1018HV
AJ Smits, MD, aj.smits@vumc.nl
FW Bloemers, MD, PhD
About this study
Official title: Orthosis Versus no Orthosis After Dorsally Fixated Traumatic Thoracolumbar Fractures
Rationale: There is no evidence in the current literature regarding the additional value of an orthosis after surgically treated thoracolumbar spine fractures.
Objective: To assess whether an orthosis provides additional pain relief compared to no orthosis after posteriorly fixated thoracolumbar spine fractures. Primary outcome is difference in pain at six weeks post-operatively. Secondary objectives are pain at other moments, pain medication used, pain related disability, quality of life, long-term kyphosis, possible complications, hospital stay, return to work and subjective feeling on benefit or disadvantage from the orthosis.
Read more
Study design: Randomized controlled intervention study, non-inferiority trial.
Study population: Dutch speaking patients presented at the VU university medical centre, 18 - 65 years old with a traumatic thoracolumbar spine fracture from Th7 - L4 surgically treated by posterior fixation.
Intervention: One group receives standard care and wears an orthosis after surgery for 12 weeks, to use when in vertical position. The intervention group does not wear an orthosis after surgery.
Main study parameters/endpoints: Main study outcome is the difference in pain noted on the NRS-score at six weeks, ≥ 2 (SD 2,5) change corresponds with a clinically significant change in pain score.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The current guideline for postoperative care regarding dorsal stabilization of spine fractures recommends the use of a post-operative orthosis. While patients generally receive an orthosis for 12 weeks, individual surgeon's believes sometimes gives reason to deviate from this guideline. This is founded by literature that increasingly questions the use of orthoses in the conservative treatment of spine fractures. With the fracture operatively stabilized, the orthosis mainly provides support of gesture and thereby potentially results in pain relief and confidence for patients. On the other hand some patients have a hard time weaning from the orthosis or report discomfort due to the device and prefer not to use it. With subjects being randomized between the use of an orthosis or no orthosis there is no additional risk. This is in part because it is hypothesized that there is no difference in postoperative pain and there might be a lower risk of complications related to the orthosis.
- Conditions
- Spine Fracture, Orthosis, Traumatic Fracture, Posterior Fixation
- Being tested
- No orthosis, Orthosis
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No orthosisOther
The intervention consists of a deviation of the standard protocol; patients do not receive a post-operative orthosis
OrthosisDevice
Patients receive post-operative care following the standard protocol and wear an orthosis for 10-12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| No orthosis | Experimental | The intervention consists of a deviation of the standard protocol; patients post-operatively do not receive an orthosis. Receives: Other: No orthosis |
| Orthosis | Active comparator | As in correspondence with local and international guidelines, patients receive an orthosis as standard post-operative care. This is considered the control group. Receives: Device: Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (NRS)
Measured: 6 weeks
Secondary outcomes (4)
Pain (NRS)
Measured: Post-operative, 2 & 12 weeks
Quality of life (EQ-5D)
Measured: Post-operative, 12 weeks & 6, 12 months
Back pain related function (ODI)
Measured: Post-operative, 2, 6, 12 weeks & 6, 12 months
Kyphosis (Cobb-angle)
Measured: Pre-operative, post-operative, 6, 12 weeks & 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startNov 2016
- Primary completionJan 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spine FractureStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AJ Smits, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097081
- Sponsor's protocol ID
- ORNOT-trial
- Acronym
- ORNOT
- Status last verified
- Jan 2023
- First submitted
- 20 Mar 2017
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Smits AJ, Deunk J, Stadhouder A, Altena MC, Kempen DHR, Bloemers FW. Is postoperative bracing after pedicle screw fixation of spine fractures necessary? Study protocol of the ORNOT study: a randomised controlled multicentre trial. BMJ Open. 2018 Jan 13;8(1):e019596. doi: 10.1136/bmjopen-2017-019596.
PubMed 29331975
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthosis Versus no Orthosis After Dorsally Fixated Traumatic Thoracolumbar Fractures
- ClinicalTrials.gov ID
- NCT03097081
- Acronym / sponsor ID
- ORNOT / ORNOT-trial
- Conditions
- Spine Fracture, Orthosis, Traumatic Fracture, Posterior Fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 31 Mar 2017 (actual)
- 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.
Rationale: There is no evidence in the current literature regarding the additional value of an orthosis after surgically treated thoracolumbar spine fractures.
Objective: To assess whether an orthosis provides additional pain relief compared to no orthosis after posteriorly fixated thoracolumbar spine fractures. Primary outcome is difference in pain at six weeks post-operatively. Secondary objectives are pain at other moments, pain medication used, pain related disability, quality of life, long-term kyphosis, possible complications, hospital stay, return to work and subjective feeling on benefit or disadvantage from the orthosis.
Study design: Randomized controlled intervention study, non-inferiority trial.
Study population: Dutch speaking patients presented at the VU university medical centre, 18 - 65 years old with a traumatic thoracolumbar spine fracture from Th7 - L4 surgically treated by posterior fixation.
Intervention: One group receives standard care and wears an orthosis after surgery for 12 weeks, to use when in vertical position. The intervention group does not wear an orthosis after surgery.
Main study parameters/endpoints: Main study outcome is the difference in pain noted on the NRS-score at six weeks, ≥ 2 (SD 2,5) change corresponds with a clinically significant change in pain score.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The current guideline for postoperative care regarding dorsal stabilization of spine fractures recommends the use of a post-operative orthosis. While patients generally receive an orthosis for 12 weeks, individual surgeon's believes sometimes gives reason to deviate from this guideline. This is founded by literature that increasingly questions the use of orthoses in the conservative treatment of spine fractures. With the fracture operatively stabilized, the orthosis mainly provides support of gesture and thereby potentially results in pain relief and confidence for patients. On the other hand some patients have a hard time weaning from the orthosis or report discomfort due to the device and prefer not to use it. With subjects being randomized between the use of an orthosis or no orthosis there is no additional risk. This is in part because it is hypothesized that there is no difference in postoperative pain and there might be a lower risk of complications related to the orthosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No orthosis | Experimental | Other: No orthosisThe intervention consists of a deviation of the standard protocol; patients post-operatively do not receive an orthosis. |
| Orthosis | Active comparator | Device: OrthosisAs in correspondence with local and international guidelines, patients receive an orthosis as standard post-operative care. This is considered the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 - 65 years
- Traumatic thoracolumbar spine fracture from thoracic 7 - lumbar 4
- AO fracture types A-C
- Undergoing surgical dorsal fixation for fracture
Key exclusion criteria (14 listed)
- Inadequate knowledge of Dutch language or to fill in questionnaire
- Complete or partial spinal cord injury (ASIA A to D)
- (Additional) anterior surgical stabilization
- Thoracolumbar fracture of other aetiology than traumatic, e.g. pathologic, infectious
- Not able to walk before fracturing vertebra
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 |
|---|---|---|
| No orthosisThe intervention consists of a deviation of the standard protocol; patients do not receive a post-operative orthosis | Other | No orthosis |
| OrthosisPatients receive post-operative care following the standard protocol and wear an orthosis for 10-12 weeks. | Device | Orthosis |
Primary outcome
Pain (NRS)
Time frame: 6 weeks
4 secondary outcomes
Pain (NRS)
Time frame: Post-operative, 2 & 12 weeks
Quality of life (EQ-5D)
Time frame: Post-operative, 12 weeks & 6, 12 months
Back pain related function (ODI)
Time frame: Post-operative, 2, 6, 12 weeks & 6, 12 months
Kyphosis (Cobb-angle)
Time frame: Pre-operative, post-operative, 6, 12 weeks & 6, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 29331975Smits AJ, Deunk J, Stadhouder A, Altena MC, Kempen DHR, Bloemers FW. Is postoperative bracing after pedicle screw fixation of spine fractures necessary? Study protocol of the ORNOT study: a randomised controlled multicentre trial. BMJ Open. 2018 Jan 13;8(1):e019596. doi: 10.1136/bmjopen-2017-019596.
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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.
AJ Smits, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No orthosis and Orthosis in people with Spine Fracture and Orthosis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AJ Smits, MD (aj.smits@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (NRS) (time frame: 6 weeks). 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 NCT03097081, which also lists 1 linked publication.
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 25 Jan 2023.