|Year : 2019 | Volume
| Issue : 2 | Page : 138-145
A comparative prospective study of clinical and radiological outcomes between open and minimally invasive transforaminal lumbar interbody fusion
Sai Gautham Balasubramanian, Sandeep Sonone, Aditya Anand Dahapute, Saurabh Muni, Rohan Gala, Nandan Marathe, Kuber Sakhare, Shubhanshu Bhaladhare
Department of Orthopaedics, Seth G. S. Medical College and King Edwards Memorial Hospital, Mumbai, Maharashtra, India
|Date of Web Publication||23-Jul-2019|
Dr. Aditya Anand Dahapute
King Edwards Memorial Hospital, 6th Floor New Building, Ortho Office, Parel, Mumbai - 400 012, Maharashtra
Source of Support: None, Conflict of Interest: None
Context: Fusion of lumbar spine is one of the standards of care for various pathologies such as lumbar canal stenosis and spondylolisthesis. Transforaminal lumbar interbody fusion (TLIF) achieves the necessary goals but with greater muscular trauma due to denervation and loss of muscle mass which may result in poor short-term outcomes. Minimally invasive-TLIF (MIS-TLIF) overcomes these shortcomings by preserving the muscle mass by splitting and dilating the muscles. Aims: The goals of the minimally invasive procedures are to reduce iatrogenic muscle injury, postoperative pain, and disability without compromising on the goals of the surgery. Aim of this study was to compare the 1-year postoperative results of TLIF by a minimally invasive technique and open approach in relation to improvement in functional outcome and interbody fusion. Settings and Design: This was a prospective study. Subjects and Methods: We performed a comparative prospective study on 80 patients. All patients were followed up for minimum of 1-year postoperatively. Functional outcome in all patients was assessed by visual analog scale (VAS), Oswestry Disability Index (ODI), and short form-36 (SF-36) scores. Creatinine phosphokinase (CPK) was assessed at the third-day postoperatively. All patients were radiologically assessed with X-rays and computed tomography scans at 1 year to assess fusion. Statistical Analysis Used: SPSS version 17 was used for analysis. P < 0.05 was considered to be statistically significant. Results: We found that CPK levels as measured on the 3rd-day postoperatively were less (statistically significant) in MIS-TLIF group (16.56 + 4.41 u/L vs. 24.52 + 7.2 u/L). The functional outcomes of the patient measured by VAS, modified ODI, and SF-36 were significantly improved (P < 0.05) at the end of 6 weeks, but long-term outcomes were not statistically significant. However, radiation exposure was increased in MIS-TLIF. Conclusion: It can be safely concluded that the immediate postoperative benefits of MIS-TLIF are better compared to open group due to lesser tissue trauma which corresponds to better functional outcome to the patients. However, the outcomes at 1-year follow-up were equal and comparable to the open TLIF.
Keywords: Creatinine phosphokinase, interbody fusion, minimally invasive transforaminal lumbar interbody fusion, open transforaminal lumbar interbody fusion
|How to cite this article:|
Balasubramanian SG, Sonone S, Dahapute AA, Muni S, Gala R, Marathe N, Sakhare K, Bhaladhare S. A comparative prospective study of clinical and radiological outcomes between open and minimally invasive transforaminal lumbar interbody fusion. Indian Spine J 2019;2:138-45
|How to cite this URL:|
Balasubramanian SG, Sonone S, Dahapute AA, Muni S, Gala R, Marathe N, Sakhare K, Bhaladhare S. A comparative prospective study of clinical and radiological outcomes between open and minimally invasive transforaminal lumbar interbody fusion. Indian Spine J [serial online] 2019 [cited 2020 Jan 29];2:138-45. Available from: http://www.isjonline.com/text.asp?2019/2/2/138/263277
| Introduction|| |
Fusion of the lumbar spine is the standard of care for instability in the lumbar spine such as lumbar canal stenosis and spondylolisthesis. The goal is to prevent motion at the segment affected, with or without decompression surgery to provide stable spinal segment by restoring the disc height and vertebral alignment. Lumbar fusion can be used to reduce pain and decrease disability in patients with chronic low back pain. Restoration of the disc height by graft/cage and stabilization (interbody fusion) definitely has biomechanical advantage as compared with posterolateral fusion (intertransverse fusion). Posterior lumbar interbody fusion (PLIF) achieved the necessary goals but with higher rate of complications associated with nerve and dural sleeve retraction. Harms and Jeszenszky first used transforaminal lumbar interbody fusion (TLIF) in 1980s and the procedure has added advantages over PLIF. It allows for unilateral exposure, decreases neural retraction avoiding potential neurological injury, and preserves the integrity of posterior column by minimizing contralateral lamina, facet, and pars resection, which are removed partially during PLIF. However, open TLIF (O-TLIF) is also associated with more muscle trauma by retraction and detachment of muscles from their original attachments resulting in relatively poor clinical short- and long-term outcomes due to denervation and loss of muscle mass., As the demands for a spinal fusion have increased for elderly population, the morbidity associated with these open procedures such as blood loss, increased neural complication rates, infection, longer hospital stays with longer narcotic usage has increased and exposes the population to undesirable surgical risks. Minimally invasive TLIF (MIS-TLIF) allows to overcome the shortcomings of O-TLIF by preserving the muscle mass by splitting the muscles into intermuscular planes avoiding denervation of muscles while achieving the goals of traditional procedures., The procedure utilizes tubular retractors, introduced by Foley, inserted serially under radiological guidance through a muscle-dilating approach, thus reducing the amount of iatrogenic muscle and soft-tissue injuries.
The aim of this study was to compare the functional and clinicoradiological outcomes between O-TLIF and minimally invasive TLIF group of patients.
| Subjects and Methods|| |
We performed a comparative prospective study on 84 patients with lytic, degenerative listhesis, and instability in the lumbar spine by doing a TLIF using open and MIS-TLIF. After Institutional Ethics Committee approval, patients were recruited from September 2014 to September 2016 for the study. All clinical parameters were same preoperatively in both the groups, and both the methods were discussed with the patients and allocated to either group accordingly by randomization through random number table. Forty-two patients were included in each group, however, four patients were lost in follow-up or due to insufficient data (40 MIS-TLIF and 40 O-TLIF). The groups were similar in age, gender, sample size, and spinal levels operated.
All patients presenting with low back pain and radiculopathy were preoperatively evaluated with clinical examination, radiographs (both flexion and extension views of lumbar spine), and magnetic resonance imaging. Lumbar instability was based on the evidence of dynamic anterior-posterior translation of 4 mm or more and/or angulation ≥10° on flexion-extension films. All the patients were given a trial of conservative management for 3 months before surgery which included steroids, anti-inflammatory medications along with physiotherapeutic exercises. Those who did not improve were included in the study. All patients who underwent single-level TLIF were included in the study.
The indications of the surgery were as follows:
- Recurrent disc prolapse
- Lumbar canal stenosis which required more than 50% of facet resection for adequate decompression.
- Multilevel disease (>3 level disease)
- ≥Grade 3 spondylolisthesis
- Revision surgeries
- Infectious pathology
- Acute trauma.
All patients were followed up for a minimum of 1-year duration postoperatively and assessed both functionally and radiologically. Functional outcome in all the patients was assessed by visual analog scale (VAS), modified Oswestry Disability Index (ODI index), and short form (SF-36) scores preoperatively and at the end of 1st and 6th week, 3rd and 6th month, and 1-year postoperatively. The marker for muscle injury, creatinine phosphokinase (CPK), was assessed at third-day postoperatively. The postoperative questionnaire was administered by an independent interviewer who was not part of the study.
Intraoperative parameters such as operative time, blood loss during the surgery, perioperative blood transfusions, and postoperative hemoglobin were also noted and compared. The incidence of intraoperative complications such as neural injury and dural tear and postoperative complications such as neurological deficits, incidence of cerebrospinal fluid (CSF) leaks and infection, recurrence of radicular pain due to inadequate mechanical neural decompression, and incidence of resurgery were noted for one year. The time to ambulation, length of stay in the hospital, rehabilitation protocol, and return to activities of daily living and functional activities were monitored and compared.
All patients were radiologically assessed with preoperative and postoperative imaging studies which included X-rays at immediate postoperative, 3 months, and 6 months and computed tomography scans at 1 year to assess fusion.
Definitive fusion was identified by the formation of trabecular bone bridges between contiguous vertebral bodies at the instrumented levels, intact hardware, and on dynamic views no translation or angulation at the adjacent vertebral levels.
The target sample size was 80. The sample size was calculated using method described by Dupont and Plummer (1990) for continuous response measures in two independent groups. Results were analyzed using standard tests for correlation of nonparametric variables (grade) according to the sample size. Qualitative data were calculated as percentages. Association between qualitative variables was assessed using the Chi-square test with continuity correction for all 2 × 2 tables and without continuity correction in rest and Fisher's exact test for all 2 × 2 tables where P value of Chi-square test was not valid due to small count. Quantitative data was represented using mean ± standard deviation (SD) and/or median with range. Analysis of quantitative data between a qualitative variable with two subgroups was done using unpaired t-test if data passed “normality test” and by Mann–Whitney test if data failed “normality test.” Results were graphically represented wherever necessary. SPSS version 17 (UNICOM Systems, Inc., Mission Hills, California) was used for most analysis. P < 0.05 was considered to be statistically significant.
| Results|| |
A total of 84 patients who fulfilled the inclusion criteria underwent TLIF for various indications and pathology. Four patients were excluded from the study due to insufficient data or lost to follow-up. Hence, 80 patients were included in the study with 40 in O-TLIF (n = 40) and 40 patients in MIS-TLIF (n = 40). The gender distribution of these enrolled participants was equal, which was 40 males and 40 females. The mean age of the participants in the study was 48.4 ± 11.44 years. The mean duration of MIS-TLIF procedure (2.85 ± 0.77 h) was more as compared to that of the O-TLIF (2.625 ± 0.5 h), but the difference was not statistically significant.
The intraoperative blood loss was calculated for both the procedures. It was found that though the blood loss in the MIS-TLIF group was lesser (250 ± 63.24 ml) as compared to that in the O-TLIF group (285.72 ± 86.44 ml), the difference was not statistically significant.
The postoperative hemoglobin for each of the patients was compared with the preoperative hemoglobin value of that patient, in both the MIS-TLIF and the O-TLIF groups. The postoperative value in the MIS-TLIF as well as the O-TLIF was not significantly different statistically from the preoperative values in that group.
The levels of serum C-reactive proteins (serum CRP) were measured on the third postoperative day. The CRP level in the MIS-TLIF group (42.06 + 20.9 mg/L) was not significantly different from that of the O-TLIF group (52.71 ± 23.37 mg/L).
The serum creatine phosphokinase (CPK) levels were also measured on third postoperatively day in the patients of the two procedural groups. It was found that the MIS-TLIF group showed lower levels (16.56 ± 4.41 u/L) which was statistically significant as compared to the O-TLIF group (24.52 ± 7.2 u/L) [Figure 1].
All the patients in either group were mobilized with a lumbar corset and started on back strengthening and core strengthening exercise programs.
The fluoroscopic images intraoperatively were lesser in O-TLIF group (mean 8 ± 4 vs. 33 ± 12) when compared to MIS group, suggesting increased radiation exposure to the patients, surgeons, and technicians and the associated steep learning curve with the procedure.
The VAS score was assessed for all the groups, once preoperatively and then after 1 week, 3 weeks, 6 weeks, 3 months, and 6 months, as shown in [Table 1]. It was found that the VAS score (back) in the MIS-TLIF group measured postoperatively at 1 week and 3 weeks was significantly lower in the MIS-TLIF group as compared to the O-TLIF group (P < 0.05). However, the VAS scores were not significantly different on the other measured time points.
The graphical representation of the VAS scores is given in [Figure 2].
The ODI was assessed at various time points after the procedure. As in case of VAS scoring, the ODI was assessed preoperatively followed by postoperative assessment at 1 week, 3 weeks, 3 months, and 6 months [Table 2]. The index scores were found to be significantly low in the MIS-TLIF group at 1-week and 3-week postoperatively, as compared to the O-TLIF group (P < 0.05). The index scores were, however, not significantly different on the other measured time points.
|Table 2: Oswestry Disability Index readings at various time-points VAS Score (0-10)|
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The graphical representation of the ODI scores is given in [Figure 3].
The physical component summary (PCS) and the mental component summary (MCS) were assessed using SF-36 questionnaire, and these were scored in percentage format. The assessment for both PCS and MCS was done preoperatively followed by postoperative evaluation at 1 week, 3 weeks, 3 months, and 6 months. It is represented in [Table 3] and [Table 4].
The PCS scores when assessed at the mentioned time points showed a trend of increase in both the study groups. However, the increase in the MIS-TLIF group was significantly more at 1 week and 3 weeks assessment as compared to the O-TLIF group. [Table 3] gives the scores in mean ± SD format while the graphical representation is seen in [Figure 4].
The MCS scores were also assessed at the above-mentioned timelines and converted into percentage. Like PCS, the MCS also showed an increasing trend over period, which was not significantly different between the O-TLIF and the MIS-TLIF on any postoperative duration of assessment. [Table 4] gives the MCS percentage values in mean + SD while [Figure 5] represents the MCS scores graphically.
The postoperative fusion rate was assessed for each patient after 1 year of procedure. It was found that all the patients had complete fusion by the end of the study [Table 5]. [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10], [Figure 11], [Figure 12], [Figure 13] illustrates the preoperative and post operative images showing fusion after minimally invasive TLIF and open TLIF at the end of 1 year respectively.
|Figure 6: Preoperative sagittal view showing complete stenosis of canal at L4-L5 level - minimally invasive TLIF group (MIS group) (Case number 27)|
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|Figure 7: Axial magnetic resonance imaging images showing canal stenosis - minimally invasive TLIF group (MIS group) (Case number 27)|
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|Figure 8: (a) Immediate postoperative X-ray anteroposterior view. (b) Postoperative lateral view - minimally invasive TLIF group (MIS group) (Case number 27)|
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|Figure 9: Postoperative fusion at 1 year - minimally invasive TLIF group (MIS group) (Case number 27)|
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|Figure 11: Preoperative magnetic resonance imaging - open TLIF group (Case number 52)|
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|Figure 12: Immediate post-operative X-ray of a patient in open TLIF group (Case number 52)|
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|Figure 13: Postoperative computed tomography scan at 1 year - open TLIF group (Case number 52)|
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The VAS and ODI scores were significantly lower for the first 6 weeks in the minimally invasive TLIF group which corresponded to the faster return to light activities and moderate recreational sports and faster recovery. Furthermore, all the patients were discharged earlier for the MIS group (3 ± 2 days vs. 7 ± 3 days) corresponding to the better functional levels in the patients.
Of the 80 patients, one patient had wound infection from O-TLIF for which complete debridement and wash were given. The patient recovered completely postdebridement.
There was an incidence of dural tear/dural leak intraoperatively in MIS-TLIF, for which it was converted to open surgery and the tear was repaired. The patient had no complication postoperatively. The patient was included in open group for the final evaluation.
Of the 80 patients, 12 patients required blood transfusions postoperatively either due to increased blood loss intraoperatively (more than 500 ml) or low hemoglobin preoperatively (<10 mg%). Of the 12 patients, 10 patients were in the O-TLIF group and 2 were in MIS-TLIF group.
| Discussion|| |
Conventional O-TLIF technique utilizes a midline posterior incision with splitting of posterior tension band muscles and unilateral retraction of nerve roots. However, this is associated with significant morbidity in view of the extensive dissection required and iatrogenic damage or denervation of the muscles.
The goal of minimally invasive spine surgery is to achieve the same objective as conventional procedures but through a less traumatic approach. Since the MIS-TLIF procedure is done through a unilateral paraspinal approach with serial dilatation of the muscles rather than splitting and stripping of the muscles, it spares the posterior tension band. Another advantage is that the contralateral musculature is left completely intact. There is minimal injury to the ipsilateral paraspinal muscles due to the introduction of serial dilators to dilate the tract. This is unlike the O-TLIF procedure, wherein the approach itself involves a certain degree of soft-tissue trauma. Hence, lesser tissue trauma in MIS-TLIF accounts for the faster recovery, shorter hospital stay, less bleeding, and lesser postoperative pain with lesser analgesic usage with the near avoidance of complete denervation atrophy of the muscles. The pedicle screws and rods are inserted percutaneously which adds to soft-tissue preservation, by obviating far lateral stripping of paraspinal musculature.
In our study, we have found that the pain scores such as VAS, ODI, and SF-36 scores were similar preoperatively for all the patients undergoing the procedure. The immediate postoperative scores at 1st and 6th week were significantly lower in minimally invasive group than the open group. The functional recovery and patient's clinical, physical, and mental status were significantly improved in the minimally invasive group when compared preoperatively and with the open group. At 1-year follow-up, the clinical outcomes were comparable to both the groups with the average of various pain scores in both the groups lower when compared preoperatively.
Hematological parameters as a marker for tissue injury was calculated in both the groups at third postoperative day. It was found that the CRP and CPK-muscle/brain (CPK-MB) values were significantly lower in minimally invasive group than the open group. No patients had postoperative neurological complications with all patients mobilized with brace at immediate postoperative period.
Patients were also assessed radiologically at third month and sixth month X-rays and at 1 year CT scan to look for the interbody fusion and also for the complications such as pedicle screw or cage back out and failure of fusion. All patients in the study showed fusion according to Bridwell's criteria at the end of 1 year with no signs of instability. The results of the study were in correlation with various studies which highlighted the better perioperative clinical and functional outcomes of the minimally invasive technique.
Dhal et al. in their retrospective study of 42 patients found significantly reduced total blood loss and length of hospital stay in MIS-TLIF group. However, they found a higher incidence of implant-associated complications with MIS-TLIF group. This is comparable to our study in which blood loss and hospital stay were reduced in MIS-TLIF group.
Wang et al. in their prospective randomized clinical study of 79 patients found increased intraoperative fluoroscopy time in MIS-TLIF group and increased postoperative drainage volume as well as prolonged postoperative recovery time in O-TLIF group. They also found that MIS-TLIF can effectively reduce sacrospinalis muscle injury compared with O-TLIF surgery, which is conducive to early functional recovery. They concluded that in short-term, MIS-TLIF is superior to O-TLIF but in the long term, there is no significant difference between the two procedures which was in comparison to our study which showed significantly reduced CPK levels in the immediate postoperative period.
Peng et al. in their prospective study of 58 patients reported decreased fluoroscopy time and operative time in the open group, whereas less blood loss, less morphine use, and shorter hospital stay were reported in the MIS-TLIF group. Both the groups showed significant improvement in ODI score, back pain and lower limb symptoms (VAS), and quality of life (SF-36) at 6 months and 2 years, but there was no significant difference between the two groups.
Lee et al. in their prospective observational study of 144 patients showed longer fluoroscopic time, less intraoperative blood loss and no postoperative drainage, less morphine usage, early mobilization, and shorter hospital stay in MIS-TLIF group. Improvement in terms of VAS, ODI, SF-36, and return to full function was similar in both the groups.
The results of the study conducted by Peng et al. and Lee et al. were comparable to our study in which the immediate VAS, ODI, and SF-36 scores at 1 week and 3 weeks were significantly reduced in MIS-TLIF group whereas the difference in scores at 6 months was not statistically significant. This corresponds to better immediate postoperative functional recovery.
Wang et al. in their prospective study of 85 patients reported significantly lesser blood loss, lesser need for transfusion, lesser postoperative back pain, and shorter length of hospital stay in MIS-TLIF group. Radiation time was significantly longer in MIS-TLIF group.
Villavicencio et al. in their prospective study of 139 patients reported less blood loss and shorter hospital stay in MIS-TLIF group. Mean change in VAS scores postoperatively, MacNab criteria score, and overall patient satisfaction and total operative time were comparable in both the groups. They concluded that MIS-TLIF technique may provide equivalent long-term clinical outcomes compared to O-TLIF.
However, Schizas et al. in their study of 36 patients reported no difference in operative time between the two groups. MIS-TLIF group had less blood loss and shorter hospital stay. Furthermore, no difference was noted in the VAS and ODI scores.
Kim et al. in their study found that the VAS scores were improved significantly postoperatively in minimally invasive group which was comparable to our study. Furthermore, the estimated blood loss was almost three times lesser, and the hospital stay of the patient for functional recovery was two times lesser in minimally invasive group. Fusion rates in both the study were equivocal.
Shunwu et al. in his study found that the markers of muscle injury such as CPK-MB were three times significantly lower in the minimally invasive group. Furthermore, the postoperative pain scores were significantly lesser in minimally invasive group on a shorter follow-up.
Kepler et al. showed MIS group used more than seven times fluoroscopy time when compared to the open group.
Zairi et al. in his prospective study of 100 patients with 40 minimally invasive and 60 O-TLIF patients reported no significant difference in pain scores postoperatively on a longer follow-up. However, the study highlighted the shorter follow-up improvement in pain scores for the minimally invasive group, and the intraoperative bleeding was significantly lesser.
Kim et al. found that the markers of muscle injury such as CK and aldolase were significantly higher in the O-TLIF group on first and third postoperative group when compared to the MIS-TLIF group and it normalized on the seventh postoperative day.
All these studies show that there was minimal muscle injury postoperatively in MIS-TLIF group which was comparable to our study in which CPK levels at third day were significantly lower in MIS-TLIF group.
Several studies have attempted to correlate various biochemical parameters as markers of tissue trauma. Various markers include CRP, CPK-MM, and interleukins. They have concluded that minimally invasive surgery causes less local damage than open group. In a study by Kulkarni et al., the postoperative Q-CRP levels were determined on the first postoperative day. The change in the Q-CRP levels was calculated in both the groups, and the unpaired t-test was used for analysis of the significance. There was a significant change in Q-CRP levels in between the groups. The MIS-TLIF group showed a significantly smaller rise in Q-CRP levels as compared to the O-TLIF group. This is a definite indicator of lesser tissue damage in the MIS-TLIF procedure.
| Conclusion|| |
The results of this study show that the immediate postoperative benefits of the minimally invasive technique are better as compared to that of the open group, by reducing the amount of iatrogenic injury to the soft tissues and muscles, which corresponds to the better pain scores in the immediate postoperative period.
Hence, the minimally invasive technique provides a safe option for lumbar interbody fusion with better short-term and equivalent clinical and radiological long-term outcomes and less complication rate as compared with O-TLIF.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10], [Figure 11], [Figure 12], [Figure 13]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]