The use of thoracolumbar spinal orthosis in thoracolumbar fractures
Original Article

The use of thoracolumbar spinal orthosis in thoracolumbar fractures

Hani Alharbi1, Nouf Altwaijri2 ORCID logo, Norah Alromaih2, Adel Alshihri2, Taif Almutairi3, Mohammed Almizani2, Mamdoh Alhawsawi1

1Spine Surgery Department, King Saud Medical City, Riyadh, Saudi Arabia; 2Orthopedic Surgery Department, King Saud Medical City, Riyadh, Saudi Arabia; 3College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia

Contributions: (I) Conception and design: H Alharbi, M Alhawsawi, N Altwaijri; (II) Administrative support: H Alharbi, M Alhawsawi; (III) Provision of study materials or patients: All authors; (IV) Collection and assembly of data: All authors; (V) Data analysis and interpretation: H Alharbi, M Alhawsawi, N Altwaijri; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

Correspondence to: Nouf Altwaijri, MBBS. Orthopedic Surgery Department, King Saud Medical City, Al Imam Turki Ibn Abd Allah Ibn Muhammad, Ulaishah, Riyadh 12746, Saudi Arabia. Email: noufaltwaijri@gmail.com.

Background: Thoracolumbar fractures are classified into four categories according to the mechanism of injury and fracture morphology into compression fracture, burst fracture, flexion-distraction injury, and fracture dislocation. Unfortunately, the management of spinal fracture has lacked standardization given the many unanswered yet relevant questions regarding the outcome. However, management is generally divided into surgical and nonsurgical treatment such as orthosis. We aim to compare the clinical and the radiological outcomes of operative spinal fractures in patients with thoracolumbar spinal orthoses (TLSO) and patients without TLSO. Up to our knowledge, there are no similar studies comparing such management approaches in Saudi Arabia.

Methods: This is a retrospective cohort study conducted in King Saud Medical City which included patients over 18 years of age from the past 10 years who underwent spinal fixation with or without the use of orthotics and had at least 6 months follow-up. We have excluded any patients with degenerative diseases, spinal tuberculosis or spinal tumors. Our primary outcome was radiological outcomes and clinical outcomes among groups using orthotics postoperatively versus groups who didn’t use orthotics. Statistical analysis was done utilizing The Statistical Package for the Social Sciences (SPSS) IBM statistical computing program version 21 was used for the statistical data analysis and the alpha significance level was considered at 0.050 level.

Results: The patients were divided into two groups, patients given TLSO postoperatively (group A) (53.1%) and patients not given TLSO postoperatively (group B) (46.9%). Most of the patients had a burst fracture and most (86.4%) had endured a single level spine fracture. Bivariate Pearson’s correlations test showed the patients mean perceived pain level [the visual analogue scale (VAS)] had correlated negatively and significantly with their emotional well-being (EM-WB) score, r=−0.132, P<0.05. Moreover, the patients self-rated pain level had correlated negatively and significantly with their satisfaction level with their comfort subscale score, r=−0.156, P<0.05. The patients mean measured kyphotic angle had correlated positively with their mean comfort level satisfaction, r=0.158, P<0.05. A non-parametric Mann-Whitney U test showed that the patients who used TLSO had perceived significantly greater general health (GH) score (mean GH score =77.44) compared to those who have not used TLSO (mean GH score =70.79), Z=2.38, P=0.02. Group A perceived significantly lower satisfaction with their social limitations (mean score =71.32) compared to group B (mean score =89.47) on average, Z=2.10, P=0.040. Group B (n=38) measured a significant decline in their pain level across the three time-point measured pain levels (P<0.001).

Conclusions: Our study concludes that both groups have noticeable reductions in pain postoperatively and have shown decent results with regards to the Short Form 36 (SF-36) scores. However, further research is necessary to gain a comprehensive understanding of the varying effects of bracing versus non bracing long-term outcomes in upper thoracic and thoracolumbar fractures.

Keywords: Thoracolumbar spinal orthosis (TLSO); thoracolumbar fractures; orthosis; thoracolumbar brace

Submitted Jan 31, 2024. Accepted for publication Aug 13, 2024. Published online Sep 19, 2024.

doi: 10.21037/jss-24-14

Highlight box

Key findings

• Thoracolumbar spinal orthosis (TLSO) patients measured significantly lower kyphotic angle at one year compared to their immediate baseline postoperative time (P=0.005).

• Non TLSO and TLSO patients measured a significant decline in their pain level across the three time-point measured pain levels (P<0.001).

• TLSO group perceived significantly lower satisfaction with their social limitations (mean score =71.32) compared to non-TLSO group (mean score =89.47) on average (Z=2.10, P=0.04).

What is known and what is new?

• No established indications for postoperative bracing were found in the literature.

• Our results show an effect of TLSO on the kyphotic angle at the latest follow up which should guide physicians in their decision for its use if further kyphosis is a concern.

• Our results also show no difference in pain control between groups which should help guide physicians in the decision on its use solely for pain control. To provide a more cost-effective care.

What is the implication, and what should change now?

• The effect of TLSO on the kyphotic angle should guide physicians in their decision for its use if further kyphosis is a concern.

• The fact that there is no difference in pain control between groups should help guide physicians in the decision on whether to use it or not for pain control.

• Further long-term studies are needed to fully understand the long-term functional outcome of TLSO use and determine whether its use is cost effective and beneficial for the patients.

Introduction

Thoracolumbar fractures most commonly occur at the level of the thoracic junction (T10–L2) (1). They are primarily classified based on pathomorphological criteria (2), such as the Denis three column theory (3) which emphasizes the biomechanical importance of the middle column, implying that fractures involving the middle column are considered unstable. The fractures were further classified into four categories according to the mechanism of injury and fracture morphology into compression fracture, burst fracture, flexion-distraction injury (seat-belt injury), and fracture dislocation (3).

Unfortunately, the management of spinal fracture has lacked standardization given the many unanswered yet relevant questions regarding the outcome (4-8). Multiple treatment strategies including a variety of surgical and nonsurgical options are implemented and studied in the context of upper thoracic and thoracolumbar fractures. However, the ideal treatment remains controversial with no clear consensus and high-quality evidence supporting either option (9-12). However, management is generally divided into surgical and nonsurgical (conservative) treatment such as orthosis. The main aims of both options are to control pain, early mobilization, mechanical and neurological stability, and to prevent complications (13,14). It is wise to say that nonoperative treatment is not suitable for patients with neurological deficits or highly unstable fractures that leave the neurological structures vulnerable to injury and damage (11,12). In the setting of intact neurological status, conservative measures are a valid option taking into consideration the type of fracture and associated ligamentous injury both of which play a role in stability of the fracture (11). For example, anterior wedge compression one type of fractures that can be treated with conservative measures. Severe compression fractures with characteristics of instability in which there is greater than 30° local kyphosis, greater than 50% loss of vertebral body height, or if there are three contiguous levels involved, are better treated surgically for further stabilization (11,12,15-18). Whereas burst fractures can present in a variety of forms with lack of consensus regarding its treatment as it may or may not warrant surgical treatment. A considerable amount of literature exists supporting both options (11,12,15-33). The main goal of surgical intervention would be to provide stability and allow for faster mobilization for those with fixed complete neurological injury with relatively little expectation of neurological recovery, and to help preserve and possibly regain neurological function for those with incomplete injuries (11,12). Furthermore, management is directed by the patient’s neurological status, whether deficit is present or not. Patients who have neurological deficits are surgically managed with decompression and fixation. Formerly, thoracolumbar burst fractures were managed with surgical fixation but there’s a shift towards conservative management in the recent years (21,32,34-36). The use of spinal orthosis postoperatively is controversial, rationale for its use includes improving arthrodesis, implanted hardware support, minimizing dangerous gross truncal movements and pain control for the patient (10,37). On the other hand, thoracolumbar spinal orthoses (TLSO) carry their own morbidity and costs. Several disadvantages of spinal orthoses have been identified by Agabegi et al. such as pressure induced ulcers, skin maceration, deconditioning of paraspinal muscles and trunk stabilizers, poor patient compliance, and disuse osteopenia (38).

We aimed to compare the clinical and the radiological outcomes of operative spinal fractures in patients with TLSO and patients without TLSO. Up to our knowledge, there are no similar studies comparing such management approaches in Saudi Arabia. We present this article in accordance with the STROBE reporting checklist (available at https://jss.amegroups.com/article/view/10.21037/jss-24-14/rc).

Methods

This is a retrospective cohort study conducted in King Saud Medical City which included patients over 18 years of age from the past 10 years who underwent spinal fixation with or without the use of orthotics and had at least 6 months follow-up. All patients meeting the inclusion and exclusion criteria were included in the study. The type of orthotics used in this study was TLSO for patients with fractures below the level of T7 and extension brace was used to offer additional support to patients with injuries at or above the level of T7. The medical records and spine radiological findings for 81 upper thoracic and thoracolumbar fracture patients were reviewed retrospectively and the patients were interviewed utilizing telemedicine for data collection. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). The study was approved by Institutional Review Board (IRB) at King Saud Medical City, Riyadh, Saudi Arabia (No. H-01-R-053) and informed consent was taken from all the patients. Participant’s anonymity was ensured. Each participant was assigned with an identification code number for the purpose of analysis.

Our inclusion criteria were patients over 18 years of age, patients with any type of spinal fractures, patients who underwent posterior spinal fixation with or without fusion. Our exclusion criteria were any patients with degenerative diseases, spinal tuberculosis, spinal tumors, polytrauma with injuries unrelated to the spine, and patients with missing data or loss of follow-up.

The study variables were fracture level, gender and age, mechanism of injury, outcome and any possible complications.

Outcome measures

Primary outcome: radiological outcomes and clinical outcomes among groups using orthotics postoperatively versus groups who did not use orthotics.

Secondary outcome: the incident rate of complications among groups using orthotics postoperatively versus groups who did not use orthotics.

Statistical analysis

The mean and standard deviation were used to describe the continuous variables. The frequencies and percentages were used to describe categorical variables. The Cronbach’s alpha test was used to assess the internal consistency and reliability of the Short Form 36 (SF-36) questionnaire. The histograms and statistical Kolmogorov-Smirnov (K-S) tests of normality were used to assess the statistical normality assumption of metric variables. The Chi-squared test of independence was used to assess correlations between categorical variables, and a likelihood ratio (LR) corrected Chi-squared test of independence was used where statistical assumption violations for the Chi-squared test were noted. The Mann-Whitney U non-parametric test of independent groups was used to assess the statistical significance of mean differences on skewed metric variables between the levels of categorically measured variables. The bivariate Friedman’s non-parametric test of repeated measures was used to assess the statistical significance of change in patients perceived pain level and spine angles across the follow up time points. The patients measured the visual analogue scale (VAS) pain level and kyphotic angles data required to be restructured from long into wide data in order to account for time as a vector in the analysis using the generalized linear mixed models (GLMM mixed) for repeated measures data. Afterwards, multivariable GLMM mixed regression was applied to the patients repeated measured through regressing these dependent outcome variables (DV’s) against the patients’ relevant predictor independent variables (sociodemographic characteristics and treatment related factors). The association between the predictor independent variables with analyzed outcomes were expressed as multivariate adjusted beta coefficient (β) with its associated 95% confidence interval. We addressed any missing data by contacting patients over the phone and scheduling follow-up appointments, allowing us to gather any missing information or radiographs. The Statistical Package for the Social Sciences (SPSS) IBM statistical computing program version 21 was used for the statistical data analysis and the alpha significance level was considered at 0.050 level.

Results

The Internal consistency and reliability analysis findings for The RAND short form (SF-36) Survey and its subscale scores are shown in Table 1. The findings showed the form to be internally consistent and therefore reliable, with a Cronbach’s alpha of 0.930 denoting that patients were able to read its items and understand them equally reliably in its Arabic form.

Table 1

Internal consistency (reliability) analysis of the SF-36 questionnaire

Variables Number of items Cronbach’s alpha
The RAND short form (SF-36) Health Survey 1.0 36 0.930
Perceived general health 5 0.600
Physical functioning subscale 10 0.888
Emotional well-being subscale 5 0.740
Social functioning subscale 2 0.610
Role limitations due to physical health subscale 4 0.890
Role limitations due to emotional problems subscale 3 0.923
Pain/comfort level subscale 2 0.700
Energy fatigue subscale 5 0.710

SF-36, Short Form-36.

Table 2 displays the descriptive analysis findings for the patients’ sociodemographic characteristics, spine fracture characteristics and outcomes. Most patients were males at 87.7% aged between 20–30 years (50.6%). Fractures were mostly endured at the level of the first lumbar vertebra at 46.9% bearing in mind that some patients had multi leveled fractures. The patients were divided into two groups, patients given TLSO postoperatively (group A) (53.1%) and patients not given TLSO postoperatively (group B) (46.9%). Regarding the type of fracture, most of the patients had endured a burst fracture and most (86.4%) had endured a single level spine fracture. Figure 1 shows the distribution of upper thoracic and thoracolumbar fracture levels for the analyzed sample of patients.

Table 2

Descriptive analysis of patients sociodemographic and spine fracture characteristics

Characteristics Values
Sex
   Female 10 (12.3)
   Male 71 (87.7)
Age (years) 33.73±11.10
Age group
   20–30 years 41 (50.6)
   31–40 years 20 (24.7)
   41–50 years 12 (14.8)
   ≥51 years 8 (9.9)
Sustained upper thoracic and thoracolumbar fracture locations
   T1–T3 3 (3.7)
   T6–T8 3 (3.7)
   T11–T12 15 (18.5)
   L1 38 (46.9)
   L2 15 (18.5)
   L3 7 (8.6)
Upper thoracic and thoracolumbar spine fracture types
   Burst fracture 49 (62.0)
   Compression fracture 25 (31.6)
   Wedge fracture 3 (3.8)
   Chance 6 (7.6)
   Other fracture types 2 (2.5)
Spine fracture levels
   Single level 70 (86.4)
   Two levels 11 (13.6)
Use of thoracolumbar spinal orthosis post—operatively
   No (group B) 38 (46.9)
   Yes (group A) 43 (53.1)

Data are presented as n (%) or mean ± standard deviation.

Figure 1 The distribution of thoracolumbar fracture levels for the analyzed sample of patients.

Table 3 displays the descriptive analysis findings for the patients’ perceptions of SF-36. Patients least perceived general health aspect was the equality of their health compared to people they know; whereas the least perceived physical functioning aspects was the participants inability to do vigorous activities.

Table 3

Descriptive analysis of patient perceptions of SF-36 questionnaire indicators

Variables Mean Standard deviation
General health
   In general, would you say your health is 82.1 25.38
   I seem to get sick a little easier than other people 72.84 33.12
   I am as healthy as anybody I know 60.19 35.96
   I expect my health to get worse 73.15 28.44
   My health is excellent 83.33 24.37
Physical functioning
   Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports 28.18 25.03
   Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf 77.16 35.4
   Lifting or carrying grocery 88.27 26.54
   Climbing several flights of stairs 78.4 33.48
   Climbing one flight of stairs 90.74 27.51
   Bending, kneeling, or stooping 74.69 35.46
   Walking more than a mile 79.63 33.33
   Walking several blocks 91.36 25.97
   Walking one block 95.06 20.32
   Bathing and dressing yourself 91.36 23.44
Emotional well-being
   Have you been a very nervous person? 72.84 26.89
   Have you felt so down in the dumps that nothing could cheer you up? 85.43 23.67
   Have you felt calm and peaceful? 70.62 24.51
   Have you felt downhearted and blue? 83.7 26.48
   Have you been a happy person? 67.9 28.05
Social functioning
   Emotional problems interfered with your normal social activities with family, friends, neighbors, or groups? 90.74 17.43
   During the past 4 weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)? 83.64 26.86
Physical role limitations
   Ability to cut down the amount of time you spent on work or other activities 77.78 41.83
   Ability to accomplishing less than you would like 71.6 45.37
   limiting in the kind of work or other activities 65.43 47.86
   Had difficulty performing the work or other activities (for example, it took extra effort) 64.2 48.24
Emotional role limitations
   Cut down the amount of time you spent on work or other activities 77.78 41.83
   Accomplished less than you would like 82.72 38.05
   Didn’t do work or other activities as carefully as usual 79.01 40.98
Perceived pain
   How much bodily pain have you had during the past 4 weeks? 75.31 23.93
   During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)? 88.89 19.76
Energy/fatigue
   Did you feel full of pep? (enthusiasm) 59.51 25.09
   Did you have a lot of energy? (energy) 59.75 25.59
   Did you feel worn out? (less worn out = refreshed) 80.49 26.83
   Did you feel tired? (less fatigue = feeling high) 73.33 27.2

Lower score on those indicators indicate more disability, greater score however indicates more satisfaction and ability. SF-36, Short Form-36.

The descriptive analysis findings for the patients’ overall health perceptions are displayed in Table 4. Findings suggest an overall low satisfaction due to limited physical abilities. The patients’ lowest general life satisfactory aspects were their satisfaction with their energy, followed by their dissatisfaction with their physical limitations and their emotional well-being (EM-WB).

Table 4

Descriptive analysis of the upper thoracic and thoracolumbar fractured patients’ overall health perceptions

Variables Mean Standard deviation
Perceived GH subscale score 74.32 18.01
PF subscale score 81.7 21.75
EM-WB subscale score 76.1 18.22
SOC-WB subscale score 87.19 19.06
PHL subscale score 69.75 40.06
EML subscale score 79.84 37.52
Pain level 82.1 19.09
Energy/fatigue 66.91 18.83

Higher score on those subscale perception implies better satisfaction and perceptions and more energy and comfort. GH, general health; PF, physical functioning; EM-WB, emotional well-being; SOC-WB, social functioning; PHL, role limitations due to physical health; EML, role limitations due to emotional problems.

The participants were asked to select out of a list of possible spine fracture related practices, discomforts, disabilities, and difficulties they may have experienced, and the results showed that 66.1% experienced difficulty with their need to frequently change their position in order to relieve back pain as shown in Table 5. However, only 8.5% required assistance with dressing themselves.

Table 5

Patients perceived other spine fracture related disabilities and difficulties

Variables Frequency % Rank
1. I stay at home most of the time because of my back 15 25.4 17
2. I change position frequently to try and get my back comfortable 39 66.1 1
3. I walk more slowly than usual because of my back 24 40.7 6
4. Because of my back I am not doing any of the jobs that I usually do around the house 22 37.3 7
5. Because of my back, I use a handrail to get upstairs 26 44.1 3
6. Because of my back, I lie down to rest more often 19 32.2 12
7. Because of my back, I have to hold on to something to get out of an easy chair 17 28.8 14
8. Because of my back, I try to get other people to do things for me 17 28.7 15
9. I get dressed more slowly than usual because of my back 19 32.2 13
10. I only stand for short periods of time because of my back 25 42.4 5
11. Because of my back, I try not to bend or kneel down 26 44.1 4
12. I find it difficult to get out of a chair because of my back 16 27.1 16
13. My back is painful almost all the time 13 22 19
14. I find it difficult to turn over in bed because of my back 10 16.9 21
15. My appetite is not very good because of my back pain 8 13.6 23
16. I have trouble putting on my socks (or stockings) because of the pain in my back 21 35.6 9
17. I only walk short distances because of my back 22 37.3 8
18. I sleep less well because of my back 14 23.7 18
19. Because of my back pain, I get dressed with help from someone else 5 8.5 24
20. I sit down for most of the day because of my back 13 22 20
21. I avoid heavy jobs around the house because of my back 32 54.2 2
22. Because of my back pain, I am more irritable and bad tempered with people than usual 20 33.9 11
23. Because of my back, I go upstairs more slowly than usual 21 35.6 10
24. I stay in bed most of the time because of my back 10 16.9 22

Table 6 displays the bivariate Pearson’s correlations test which showed the patients mean perceived pain level (VAS score) had correlated negatively and significantly with their EM-WB score, r=−0.132, P<0.05, indicating that as patients’ EM-WB tended to rise, their mean perceived pain level declined on average. Moreover, the patients self-rated pain level had correlated negatively and significantly with their satisfaction level with their comfort subscale score, r=−0.156, P<0.05. The patients mean measured kyphotic angle had correlated positively with their mean comfort level satisfaction, r=0.158, P<0.05. Furthermore, the patients age in years had correlated positively with their mean measured kyphosis angle, r=0.133, P<0.05. Older patients measured significantly lower kyphotic angle in general. All the SF-36 subscale scores had correlated significantly and positively with each other, P<0.01 each respectively. The patients age had correlated positively and significantly with their mean perceived EM-WB score, older patients perceived greater EM-WB, r=0.171, P<0.01. Moreover, the patients age had loaded positively and significantly to their mean perceived aspects of social well-being, satisfaction with social abilities and energy level perception, P<0.05 each respectively.

Table 6

Bivariate correlations between the upper thoracic and thoracolumbar fractured patient perceptions and outcomes

Variables VAS Spine angle GH PF EM-WB SOC-WB PHL EML Comfort Energy
Post-operative (VAS) pain level score 1
X-ray measured spine angle level (degrees) score 0.126
Perceived GH score −0.075 0.011
Perceived PF score 0.003 −0.082 0.481**
Perceived EM-WB score −0.132* 0.093 0.508** 0.320**
Perceived SOC-WB score −0.086 0.045 0.530** 0.574** 0.506**
Perceived PHL score −0.124 −0.009 0.439** 0.535** 0.371** 0.632**
Perceived EML problems score −0.112 0.024 0.248** 0.525** 0.293** 0.479** 0.518**
Perceived comfort level score −0.156* −0.009 0.419** 0.492** 0.283** 0.531** 0.544** 0.455**
Perceived energy (fatigue) level score −0.091 0.158** 0.465** 0.275** 0.783** 0.448** 0.295** 0.285** 0.199**
Patients age (years) −0.063 0.133* 0.038 0.044 0.171** 0.143** 0.080 0.115* 0.011 0.226**

*, correlation is significant at the 0.05 level (two-tailed); **, correlation is significant at the 0.01 level (two-tailed). VAS, visual analogue score; GH, general health; PF, physical functioning; EM-WB, emotional well-being; SOC-WB, social functioning; PHL, role limitations due to physical health; EML, role limitations due to emotional problems.

To better understand how patients may differ in terms TLSO use with respect to their perceptions and health outcomes bivariate analyses were employed and shown in Table 7. The location of fracture had differed significantly between the two groups, according to the LR corrected Chi-squared test of independence, group A patients with L1 fractures were found to be slightly more inclined to use the TLSO, but those with T11–T12 fracture levels were found to be significantly less inclined to using TLSO (P=0.03). Interestingly, a non-parametric Mann-Whitney U test showed that the patients who used TLSO (group A) had perceived significantly greater general health score (mean GH score =77.44) compared to those who have not used TLSO (group B) (mean GH score =70.79), Z=2.38, P=0.02. Group A perceived significantly lower satisfaction with their social limitations (mean score =71.32) compared to group B (mean score =89.47) on average, Z=2.10, P=0.04 according to the non-parametric Mann-Whitney U test.

Table 7

Bivariate analysis of upper thoracic and thoracolumbar spine fracture patients not treated/ treated with TLSO

Variables Use of TLSO splint/braces Test statistic P value
No =38 (B) Yes =43 (A)
Sex, n (%)
   Female 3 (7.9) 7 (16.3) χ2(1)=0.650 0.42
   Male 35 (92.1) 36 (83.7)
Age (years), mean (SD) 34.82 (12.55) 32.77 (9.71) t(79)=0.829 0.41
Age group, n (%)
   20–30 years 17 (44.7) 24 (55.8) χ2(3)=1.93 0.59
   31–40 years 9 (23.7) 11 (25.6)
   41–50 years 7 (18.4) 5 (11.6)
   ≥51 years 5 (13.2) 3 (7.0)
Sustained upper thoracic and thoracolumbar fracture locations, n (%)
   T1–T3 0 3 (7.0) χ2(5)=12.15 0.03
   T6–T8 0 3 (7.0)
   T11–T12 9 (23.7) 6 (14.0)
   L1 15 (39.5) 23 (53.6)
   L2 10 (26.3) 5 (11.6)
   L3 4 (10.5) 3 (7.0)
Upper thoracic and thoracolumbar spine fracture types, n (%)
   Burst fracture 27 (71.1) 22 (51.2) χ2(1)=3.34 0.07
   Compression fracture 10 (26.3) 15 (34.9) χ2(1)=0.70 0.41
   Wedge fracture 1 (2.6) 2 (4.7) χ2(1)≤0.0001 NS
   Chance 2 (5.3) 4 (9.3) χ2(1)=0.072 0.49
   Other fracture types 0 2 (4.7) χ2(1)=0.40 0.53
Spine fracture levels, n (%)
   Single level 34 (89.5) 36 (83.7) χ2(1)=0.60 0.45
   Two levels 4 (10.5) 7 (16.3)
SF-36 QoL perceptions, mean (SD)
   Perceived general health 70.79 (12.82) 77.44 (21.25) Z=2.38 0.02
   Physical functioning 84.37 (14.53) 79.34 (26.52) Z=0.215 0.83
   Emotional well-being 75.26 (14.13) 76.84 (21.34) Z=1.13 0.26
   Social functioning 90.46 (15.50) 84.30 (21.50) Z=1.30 0.20
   Role limitations due to physical health 70.39 (40.63) 69.20 (40.03) Z=0.270 0.79
   Role limitations due to emotional problems 89.47 (28.10) 71.32 (42.78) Z=2.10 0.04
   Pain level 82.17 (16.76) 82.03 (21.14) Z=0.350 0.73
   Energy/fatigue 66.05 (17.01) 67.67 (20.48) Z=0.717 0.47

TLSO, thoracolumbar spinal orthosis; SD, standard deviation; SF-36, Short Form-36; QoL, quality of life; NS, not significant (P value >0.99).

To assess the statistical significance of the change in the patients experienced pain level and measured Kyphosis across time, the Friedman’s non-parametric analysis of variance (ANOVA) test was applied to each group separately. The findings are shown in Table 8. Group B (n=38) measured a significant decline in their pain level across the three time-point measured pain levels (P<0.001), according to the Friedman’s non-parametric ANOVA test, and a post-hoc pairwise comparison test between the patients measured pain level at the three time points showed that the patients pain level at 6 months was significantly lower than it was at first postoperative time (P<0.001). Moreover, their pain level at 4 months was significantly lower than it was at first month postoperative (P<0.001). Group A’s (n=43) findings showed that their pain level had declined significantly from their first to sixth postoperative time points (P<0.001), and a post-hoc pairwise comparison test between these three time points pain levels showed that the patients perceived pain level at the 6th month postoperatively was significantly lower than it was at the 1st month, also their pain level at the 4th month postoperatively was found to be significantly lower than it was at the first postoperative month, P<0.001 each respectively. Furthermore, the Friedman’s non-parametric test showed that group A had measured a significant decline in their kyphotic angle across time (P=0.04), and the pairwise post-hoc comparisons between the patients measured kyphotic angle showed that the patients 6-month postoperative time measured significantly lower spine angle (kyphosis) compared to their baseline immediate postoperative time (P=0.03). Moreover, group A patients measured significantly lower kyphotic angle at one year compared to their immediate baseline postoperative time (P=0.005), however, the patients’ angles at the other different time points may not differ significantly on average when pairwise compared, according to the Friedman’s non-parametric test.

Table 8

Descriptive bivariate analysis of patient measured pain level and spine angles across follow-up time points

Variables Follow-up time, mean (SD) P value
Pre-operative 1 month post-operatively 3 months 6 months 1 year
Group B: did not use TLSO, n=38
   Perceived level of pain (VAS) level – 7.37 (2.39) 4.3 (1.85) 2.08 (1.89) – <0.001
   X-ray measured spine angle level (degrees) 7.58 (6.56) 6.35 (5.69) 6.66 (5.25) 6.99 (4.78) 7.95 (5.20) 0.66
Group A: used TLSO, n=43
   Perceived level of pain (VAS) level – 7.19 (3.13) 3.47 (2.47) 1.51 (1.74) – <0.001
   X-ray measured spine angle level (degrees) 9.14 (6.94) 6.20 (5.28) 6.55 (6.22) 6.34 (6.53) 3.17 (1.25) 0.04

TLSO, thoracolumbar spinal orthosis; VAS, visual analogue scale; SD, standard deviation.

Discussion

Our paper aimed to investigate the effects of thoracolumbar braces on the quality of life, post operative pain and kyphotic angles. Recently, the need for bracing has been tested by several investigators by comparing fractures that were treated with or without orthosis in randomized controlled trials and have found no difference between groups (30,31,39-43). Moreover, no established indications for postoperative bracing were found in the literature despite several investigators favoring its use after surgery for thoracolumbar fractures (37,44-46). Although bracing is often considered a safe adjunct to surgical management, it is also important to keep in mind that it is not free of complications such as skin ulcers or reactions, nerve palsies, respiratory compromise, esophagitis, and a negative impact on muscle tone that all have been described in the literature (10,44-47).

A study was done in Canada in 2014, enrolled 47 patients in the TLSO group and 49 patients in the no TLSO group concluded that treating these fractures using early ambulation without a brace avoids the cost and patient deconditioning associated with a brace and complications and costs associated with long-term bed rest if a TLSO or body cast is not available (30). Kim et al. conducted a prospective randomized controlled non-inferiority trial comparing the outcomes of osteoporotic compression fractures without neurologic injury in three groups: no-brace, soft-brace, and rigid-brace (48). The study showed that there was a significant improvement in the Oswestry Disability Index and visual analog scale scores for back pain after the fracture, and the body compression ratios decreased significantly over in all three groups (48), which is quite similar to our results which denote the decline in reported pain postoperatively over time. Furthermore, Bailey et al. studied burst fracture outcomes with and without TLSO orthosis (31) with regards to Roland Morris Disability Questionnaire (RMDQ) score, VAS for pain, SF-36 scores, kyphosis and satisfaction and found no statistical difference between treatment groups (31). Similarly, Shamji et al. conducted a prospective randomized controlled trial where they investigated the difference between bracing and no-bracing in the treatment of thoracolumbar burst fractures in neurologically intact patients (39). Their results showed no documented failures of conservative management and no statistically significant differences in radiographic images or self-reported clinical outcomes during a 6-month follow-up period (39). However, the no-brace group had a substantially shorter hospital stay than the TLSO group (39). Moreover, Mulcahy et al. conducted a systematic review analyzing orthosis use versus no orthosis and confirms that early mobilization without a brace is safe and yields satisfactory outcomes (28). Wood et al. conducted a randomized clinical trial wherein patients who received nonoperative treatment with or without a brace were compared with those who underwent surgical treatment; patients who received treatment without orthosis did not exhibit any decline in their ability or a rise in pain levels in comparison to those who were treated with TLSO (29). Our results in regard to group B (no TLSO) kyphotic angle were unfortunately insignificant, however, Jaffray et al conducted a cohort study that included 60 patients who underwent conservative treatment with a brace and reported an average rise in kyphotic deformity of 3 degrees average during the period between admission and 3 months post-injury (49). A systematic review done by Skoch et al. that included 76 studies that described use of bracing and studies in which bracing was not used, all of which provided quantitative measures of at least one of the following (pain level, changes in surgically corrected kyphotic angle, return to work, screw breakage rate, or postoperative complication rate) (10). They concluded that there were no significant differences between braced and non-braced groups in terms of pain, which is similar to our paper. They also concluded that there are no differences in terms of screw breakage, infection, or return to work. Also, they observed a small but significant increase in overall complication rates and loss of kyphotic correction in the braced groups, and a higher rate of pseudoarthrosis in the non-braced groups (10). This differs from our findings, in which we concluded that the use of TLSO is beneficial in terms of kyphosis as it lowers the chances of progression.

We aimed to investigate the impact of bracing on SF-36 outcomes, which provides valuable insights into the health-related quality of life for upper thoracic and thoracolumbar fracture patients. Our findings revealed a significant difference in perceived general health between the two groups, with the group A (TLSO users) reporting higher scores (Z=2.38, P=0.02). This aligns with the results of a previous study conducted by Urquhart et al. who found that patients who utilized an orthosis demonstrated improved perceived general health (40). In addition, Urquhart et al.’s study demonstrated that orthosis users exhibited better physical functioning, as well as fewer role limitations due to physical health issues, less bodily pain, higher vitality, and improved social functioning (40). However, contrary to their findings, our study did not observe significant differences in these specific domains. The discrepancy between our study and the findings of Urquhart et al. suggests that while bracing may positively impact perceived general health, it may not consistently influence other aspects of physical functioning and quality of life as measured by the SF-36. In terms of limitations, it should be noted that our study was limited by a small sample size, which was primarily due to loss of follow-up. This might affect the generalizability of our findings to a larger and more diverse population. Therefore, conducting additional future studies with a larger sample size could provide further insights and data.

Conclusions

Our study concludes that both groups have noticeable reductions in pain postoperatively and have shown decent results with regards to the SF-36 scores. However, further research is necessary to gain a comprehensive understanding of the varying effects of bracing versus non bracing on different domains of SF-36 outcomes in upper thoracic and thoracolumbar fracture patients and the effects of bracing with regards to the kyphosis and long-term functional outcome for the patients.

Acknowledgments

We would like to acknowledge Dr. Abdulnasser Alwabel, Dr. Lina Ismael, and Dr. Mashael Alsadoon for their invaluable contributions to data collection in our study.

Funding: None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jss.amegroups.com/article/view/10.21037/jss-24-14/rc

Data Sharing Statement: Available at https://jss.amegroups.com/article/view/10.21037/jss-24-14/dss

Peer Review File: Available at https://jss.amegroups.com/article/view/10.21037/jss-24-14/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jss.amegroups.com/article/view/10.21037/jss-24-14/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). The study was approved by Institutional Review Board (IRB) at King Saud Medical City, Riyadh, Saudi Arabia (No. H-01-R-053) and informed consent was taken from all the patients.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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Cite this article as: Alharbi H, Altwaijri N, Alromaih N, Alshihri A, Almutairi T, Almizani M, Alhawsawi M. The use of thoracolumbar spinal orthosis in thoracolumbar fractures. J Spine Surg 2024;10(3):501-513. doi: 10.21037/jss-24-14

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