Thoracolumbar Burstfractures, Orthesis or No Orthesis

Spinal Fractures Clinical Trial

— BONO  

Official title:

Thoracolumbar Burstfractures, Orthesis or no Orthesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02784782
• Other study ID #: ElisabethTweeStedenZ
• Status: Recruiting
• Phase: Phase 4
• First received: March 15, 2016
• Last updated: May 26, 2016
• Start date: March 2016
• Est. completion date: July 2019

Study information

• Verified date: May 2016
• Source: Elisabeth-TweeSteden Ziekenhuis
• Contact: Wouter Bakker, drs.
• Phone: +31135392942
• Email: bono[@]etz.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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. 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.

Description:

No extra information

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: July 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Th10-L4

• AO foundation type A3 or A4 type fractures

• Single level

• Kyphosis < 35 ° at first analysis

• Neurologically intact

• Adequate trauma

Exclusion Criteria:

• Inadequate knowledge of the Dutch language

• Multitrauma, which asks for multidisciplinary treatment

• Inability to wear a brace due to overweight (BMI> 35)

• Known osteoporosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Fractures

Intervention

Device:
• Orthesis

Behavioral:
• No orthesis

Locations

Country	Name	City	State
Netherlands	Elisabeth Twee Steden ziekenhuis	Tilburg

Sponsors (2)

Lead Sponsor	Collaborator
Elisabeth-TweeSteden Ziekenhuis	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay	The amount of days spent in the hospital	From first admission until discharge from the hospital up to 10 weeks	No
Primary	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.	at six months, measured up to two years	No
Secondary	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.	up to two years	No
Secondary	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.	up to two years	No
Secondary	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.	up to two years	No
Secondary	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.	up to two years	No
Secondary	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.	up to two years	No
Secondary	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.	up to two years	No
Secondary	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.	up to two years	No