Spinal FracturesPhase 4BONONCT02784782
Thoracolumbar Burstfractures, Orthesis or No Orthesis
A Phase 4 study testing Orthesis and No orthesis in people with Spinal Fractures, run by Elisabeth-TweeSteden Ziekenhuis at 1 site in Netherlands.
Trial summary
Rationale: Thoracolumbar burst fractures are frequently seen in the trauma population, they have a large impact on patient's wellbeing and are a large economic burden to society. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Fractures
- What is being tested?
- Orthesis and No orthesis
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2016to Jul 2019
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Th10-L4
- AO foundation type A3 or A4 type fractures
- Single level
- Kyphosis < 35 ° at first analysis
- Neurologically intact
- Adequate trauma
Who cannot join
- Inadequate knowledge of the Dutch language
- Multitrauma, which asks for multidisciplinary treatment
- Inability to wear a brace due to overweight (BMI> 35)
- Known osteoporosis
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Elisabeth Twee Steden ziekenhuis
Tilburg, 5000LC
Carel Diekerhof, drs., +3113-5392942
About this study
Official title: Thoracolumbar Burstfractures, Orthesis or no Orthesis
Rationale: Thoracolumbar burst fractures are frequently seen in the trauma population, they have a large impact on patient's wellbeing and are a large economic burden to society. Thoracolumbar burst fractures might not need the standard care of brace immobilization for adequate treatment and a functional treatment might lead to same or better functional outcomes. Besides that, with functional outcome length of hospital stay might decrease and it might also be cost effective compared to bracing.
Objective: The investigators aim to study the use of braces for thoracolumbar burstfractures, not only by measuring the functional scores and the effect of the bracing or functional treatment on the increase in kyphosis angle, but also on (health related) quality of life and health economics. The investigators hypothesize that no treatment is superior over one other.
Read more
Study design: This project is a randomised controlled trial comparing brace and no brace treatment on function, kyphosis angle, pain, quality of life, and costs.
Study population: Patients between 18 and 65, with a single level thoracolumbar burst fracture will be included. The fracture has to have a kyphosis angle of less than 35 degrees and patient has to be neurologically intact. Patients are excluded when they are overweight (BMI> 35), need multidisciplinary treatment due to multitrauma, or have inadequate knowledge of the Dutch language. Patients included in the brace group will automatically take part in a brace compliance study.
Intervention: One group receives a Thoracolumbar Sacral Orthesis (TLSO) for 6 weeks, the other group receives no TLSO Main study parameters/endpoints: The primary outcome of this study is the functional score at six months after trauma. Secondary outcomes are pain, kyphosis angle, health related quality of life, healthcare costs and brace compliance.
Literature shows no difference in pain, functional outcome or kyphosis angle, therefore no potential risks are known comparing a brace and a functional treatment. Investigators aim that not using the TLSO results in similar functional outcome, pain and kyphosis angle, and less costs. Patients will be seen at first presentation and during two year follow up at the outpatient clinic at six standard care follow up moments. At these follow up moments a X-ray as part of standard care is made. At or just before each scheduled appointment they will fill in questionnaires taking from 15-45 minutes.
Read the detailed description
No extra information
- Conditions
- Spinal Fractures
- Being tested
- Orthesis, No orthesis
- Keywords
- Spinal, Vertebral, Burstfracture, Orthesis, Brace, Thoracolumbar
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthesisDevice
Also called Thoraco-Lumbar-Sacral Orthesis, Hyperextension brace
No orthesisBehavioural
Also called Functional
| Study group | Role | What they receive |
|---|---|---|
| Orthesis | Experimental | Subjects will wear a TLSO for 6 weeks 24 hours a day or they will not. After 6 weeks the subjects in the TLSO group will decrease and stop the use of the orthesis. Depending on their pain complaints patients will be admitted to the hospital and will get adequate pain management following local protocol Intervention: After fitting the patient starts mobilising, under supervision of a physiotherapist, until pain is under control with oral analgesia. Sports and heavy lifting are prohibited for 3 months. No physiotherapy treatment is needed. During two year follow up patients will be seen at the outpatient clinic during standard care follow up moments. At or just before each scheduled appointment they will fill in questionnaires. These questionnaires will take 15-45 minutes. Receives: Device: Orthesis |
| No Orthesis | Active comparator | Subjects will wear a TLSO for 6 weeks 24 hours a day or they will not. After 6 weeks the subjects in the TLSO group will decrease and stop the use of the orthesis. Depending on their pain complaints patients will be admitted to the hospital and will get adequate pain management following local protocol.
Control: The patient starts mobilising, under supervision of a physiotherapist, until pain is under control with oral analgesia. Sports and heavy lifting are prohibited for 3 months. No physiotherapy treatment is needed. During two year follow up patients will be seen at the outpatient clinic during standard care follow up moments. At or just before each scheduled appointment they will fill in questionnaires. These questionnaires will take 15-45 minutes. Receives: Behavioral: No orthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional score
Oswestry Disability Index (ODI) derived from the Oswestry Low Back Pain Questionnaire used to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Measured: at six months, measured up to two years
Secondary outcomes (7)
Quality of life score
WHOQOL-BREF is the short version of the WHOQOL 100 and is recommended for use when time is restricted or the burden on the respondent needs to be minimized. This survey has been used in large epidemiological studies and clinical trials. A self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7), psychological health (6), social relationships (3) and environment (8). Two other items measure overall QOL and general health. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5) to determine a raw item score. Subsequently, the mean score for each domain is calculated, resulting in a mean score per domain that is between 4 and 20. Finally, this mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score, with a higher score indicating a higher QOL. When transformed by multiplying x4, each domain score is then comparable with the scores used in the original WHOQOL-100.
Measured: up to two years
Patient reported health status
The Short Form (SF 36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it, the SF-6D, is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: up to two years
Quality of life score
The EuroQol-5D is a simple questionnaire with five domains (14). In the EQ-5D, health is defined along five dimensions; mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has three levels; no problem, moderate problem, or severe problem. In addition, a scoring algorithm is available by which each health status description can be expressed into a summary score. This summary score ranges from 1 for full health to 0 for death, and can be interpreted as a judgment on the relative desirability of a health status compared with perfect health.
Measured: up to two years
Pain
Visual Analogue Scale-pain (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement, in this study pain, by indicating a position along a continuous line between two end-points.
Measured: up to two years
Medical Consumption
The Institute for Medical Technology (iMTA) Medical Consumption Questionnaire (iMCQ), is a generic non disease specific instrument for measuring (direct) medical costs. The instrument is a standardized self-reported questionnaire. The iMCQ includes questions related to frequently occurring contacts with health care providers and can be complemented with extra questions that are relevant for specific study populations. A manual is available for a structured use of the questionnaire. Cost-prices be applied to the obtained healthcare utilization by the iMCQ by using the Dutch manual for cost-analyses that is written by iMTA on behalf of the Dutch Healthcare Institute.
Measured: up to two years
Productivity costs
The Productivity Cost Questionnaire (iPCQ) is a generic non-disease specific questionnaire and is applicable to national and international studies. Currently a Dutch version and an English version of the iPCQ are available. Both indirect cost due to absenteeism as the productivity losses due to presenteeism (i.e. sick, but working) are taken into account. Different methods exist to value productivity. The human-capital method takes the patient's perspective and counts any hour not worked as an hour lost. By contrast, the friction-cost method takes the employer's perspective, and only counts as lost those hours not worked until another employee takes over the patient's work. By applying wage costs the results of the iPCQ can be monetized and as such used in health economic evaluations.
Measured: up to two years
Work Ability
To gain more insight in the effects of a post-trauma status on patients work ability the Work Ability Questionnaire can be used. Originally, the work ability questionnaire consists of 7 dimensions . Recently, it was shown that a very strong association exists between the total Work ability Index (WAI)-score and score on a single-item question (i.e. Current work ability compared with the lifetime best) among all participants. Both the WAI and the single-item question showed similar patterns of associations with sick leave, health, and symptoms. The predictive value for the degree of sick leave and health-related quality of life (HRQoL) was strong for both the WAI and the single-item question. So, it suggests that the single-item question on work ability could be used as a simple indicator for assessing the status and progress of work ability in a working population. Considering the extensive questionnaire being used in the proposed study the single-item questions seems more favourable.
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FracturesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elisabeth-TweeSteden Ziekenhuis
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Wouter Bakker, Elisabeth-TweeSteden Ziekenhuis
- Investigators
- Taco Gosens, dr., Principal investigator, Elisabeth Twee Steden ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784782
- Sponsor's protocol ID
- ElisabethTweeStedenZ
- Acronym
- BONO
- Status last verified
- May 2016
- First submitted
- 15 Mar 2016
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: In this research project the investigators aim for multiple publications in scientific journals and a promotion of a PhD student. The investigators want to develop a treating protocol with better functional outcome and less costs.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracolumbar Burstfractures, Orthesis or no Orthesis
- ClinicalTrials.gov ID
- NCT02784782
- Acronym / sponsor ID
- BONO / ElisabethTweeStedenZ
- Conditions
- Spinal Fractures
- Keywords
- Spinal, Vertebral, Burstfracture, Orthesis, Brace, Thoracolumbar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Elisabeth-TweeSteden ZiekenhuisUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Mar 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 27 May 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.
Rationale: Thoracolumbar burst fractures are frequently seen in the trauma population, they have a large impact on patient's wellbeing and are a large economic burden to society. Thoracolumbar burst fractures might not need the standard care of brace immobilization for adequate treatment and a functional treatment might lead to same or better functional outcomes. Besides that, with functional outcome length of hospital stay might decrease and it might also be cost effective compared to bracing.
Objective: The investigators aim to study the use of braces for thoracolumbar burstfractures, not only by measuring the functional scores and the effect of the bracing or functional treatment on the increase in kyphosis angle, but also on (health related) quality of life and health economics. The investigators hypothesize that no treatment is superior over one other.
Study design: This project is a randomised controlled trial comparing brace and no brace treatment on function, kyphosis angle, pain, quality of life, and costs.
Study population: Patients between 18 and 65, with a single level thoracolumbar burst fracture will be included. The fracture has to have a kyphosis angle of less than 35 degrees and patient has to be neurologically intact. Patients are excluded when they are overweight (BMI> 35), need multidisciplinary treatment due to multitrauma, or have inadequate knowledge of the Dutch language. Patients included in the brace group will automatically take part in a brace compliance study.
Intervention: One group receives a Thoracolumbar Sacral Orthesis (TLSO) for 6 weeks, the other group receives no TLSO Main study parameters/endpoints: The primary outcome of this study is the functional score at six months after trauma. Secondary outcomes are pain, kyphosis angle, health related quality of life, healthcare costs and brace compliance.
Literature shows no difference in pain, functional outcome or kyphosis angle, therefore no potential risks are known comparing a brace and a functional treatment. Investigators aim that not using the TLSO results in similar functional outcome, pain and kyphosis angle, and less costs. Patients will be seen at first presentation and during two year follow up at the outpatient clinic at six standard care follow up moments. At these follow up moments a X-ray as part of standard care is made. At or just before each scheduled appointment they will fill in questionnaires taking from 15-45 minutes.
Detailed description
No extra information
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthesis | Experimental | Device: OrthesisSubjects will wear a TLSO for 6 weeks 24 hours a day or they will not. After 6 weeks the subjects in the TLSO group will decrease and stop the use of the orthesis. Depending on their pain complaints patients will be admitted to the hospital and will get adequate pain management following local protocol Intervention: After fitting the patient starts mobilising, under supervision of a physiotherapist, until pain is under control with oral analgesia. Sports and heavy lifting are prohibited for 3 months. No physiotherapy treatment is needed. During two year follow up patients will be seen at the outpatient clinic during standard care follow up moments. At or just before each scheduled appointment they will fill in questionnaires. These questionnaires will take 15-45 minutes. |
| No Orthesis | Active comparator | Behavioral: No orthesisSubjects will wear a TLSO for 6 weeks 24 hours a day or they will not. After 6 weeks the subjects in the TLSO group will decrease and stop the use of the orthesis. Depending on their pain complaints patients will be admitted to the hospital and will get adequate pain management following local protocol. Control: The patient starts mobilising, under supervision of a physiotherapist, until pain is under control with oral analgesia. Sports and heavy lifting are prohibited for 3 months. No physiotherapy treatment is needed. During two year follow up patients will be seen at the outpatient clinic during standard care follow up moments. At or just before each scheduled appointment they will fill in questionnaires. These questionnaires will take 15-45 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Th10-L4
- AO foundation type A3 or A4 type fractures
- Single level
- Kyphosis < 35 ° at first analysis
- Neurologically intact
Key exclusion criteria (4 listed)
- Inadequate knowledge of the Dutch language
- Multitrauma, which asks for multidisciplinary treatment
- Inability to wear a brace due to overweight (BMI> 35)
- Known osteoporosis
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 |
|---|---|---|
| OrthesisAlso: Thoraco-Lumbar-Sacral Orthesis, Hyperextension brace | Device | Orthesis |
| No orthesisAlso: Functional | Behavioural | No Orthesis |
Primary outcome
Functional score
Time frame: at six months, measured up to two years
Oswestry Disability Index (ODI) derived from the Oswestry Low Back Pain Questionnaire used to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
7 secondary outcomes
Quality of life score
Time frame: up to two years
Patient reported health status
Time frame: up to two years
Quality of life score
Time frame: up to two years
Pain
Time frame: up to two years
Medical Consumption
Time frame: up to two years
Productivity costs
Time frame: up to two years
Work Ability
Time frame: up to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Individual participant dataSharing planned: Yes. In this research project the investigators aim for multiple publications in scientific journals and a promotion of a PhD student. The investigators want to develop a treating protocol with better functional outcome and less costs.
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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.
Taco Gosens, dr. principal investigator
Elisabeth Twee Steden ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Orthesis and No orthesis in people with Spinal Fractures, run by Elisabeth-TweeSteden Ziekenhuis 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 6 inclusion and 4 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 27 May 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Wouter Bakker, drs. (+31135392942, bono@etz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional score (time frame: at six months, measured up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2016.