Lupine Publishers | The Prognostic Value of One-Step Nucleic Acid Amplification (OSNA) and Immunohistochemistry (IHC) in Ex Vivo Sentinel Lymph Nodes in Stage I & II Colonic Cancer Patients - A Multicenter Cohort Study

Lupine Publishers | Open Access Journal of Oncology and Medicine (OAJOM)

Abstract

Introduction: Sentinel lymph node (SLN) mapping with multilevel-sectioning and immunohistochemistry (IHC) or One- Step Nucleic Acid Amplification (OSNA) are considered promising techniques to improve LN staging in colon cancer. This study investigates the prognostic significance of OSNA- and IHC-analysis of ex vivo SNLs of stage I&II colon cancer patients.

Methods: 86 stage I&II colon cancer patients were identified from two previously conducted cohort studies. All SLNs were examined with Hematoxylin & Eosin-staining (H&E), multilevel-sectioning with IHC and OSNA analysis. Kaplan-Meier and coxregression analysis were performed to determine the prognostic significance.

Results: Mean disease-free survival (DFS) for OSNA-positive vs OSNA-negative patients was 62.5 vs 62.0 months (p=0.886) and for IHC-positive vs IHC-negative patients 58.1 vs 62.9 months (p=0.519). Cox-regression analysis showed that positive OSNAstatus was not prognostic for DFS (hazard ratio (HR)=0.89, p=0.886). Additionally, also positive IHC-status showed no significant difference for DFS (HR 1.47, p=0.522).

Conclusions: Additional OSNA or IHC-analysis of ex vivo SLNs does not provide a more accurate prognostic value in this small group of stage I&II colon cancer patients compared with conventional H&E. A bigger study is needed to set these results in a broader perspective. Further research is required to identify other clinically relevant upstaging techniques and prognostic factors to tailor the treatment plans of these patients.

 Colorectal cancer (CRC) is the third most common cancer worldwide with nearly 1,4 million newly diagnosed patients each year, accounting for 8% of all cancer related deaths [1,2]. In CRC, oncologic surgical resection is the primary therapy, followed by adjuvant chemotherapy on indication. Lymph node (LN) metastasis are one of the most important prognostic factors and are associated with worsened 5-year survival [3]. Previous studies demonstrated that 20-30% of node negative (stage I&II) patients suffer from disease recurrence within 5 years after surgery [4,5]. This could suggest that current conventional histopathological staging procedures, consisting of one or two sections of Hematoxylin & Eosin (H&E) through each detected LN, may not be precise enough to accurately describe the metastatic load in the resected LNs, possibly leading to undertreatment [6]. More accurate staging techniques are therefore needed to upstage colorectal patients considered to be node negative with conventional H&E examination. In order to improve the detection of LN metastasis, different techniques have been investigated. Sentinel lymph node (SLN) mapping with multilevel-sectioning and immunohistochemistry (IHC) has been proposed as a promising technique for improved LN staging in patients with colorectal cancer [6,7]. Various studies have demonstrated that the use of either in-vivo or ex-vivo SLN mapping can achieve upstaging rates up to 35% in CRC patients [6, 7]. More recently, the use of One-Step Nucleic Acid Amplification (OSNA) has been trialed in patients with CRC [8-10]. This technique, which is already used in approximately 200 centers as an intra-operative diagnostic tool in breast cancer patients, uses the reversetranscription loop-mediated isothermal amplification (TR-LAMP) method for mRNA amplification [11]. OSNA determines, within 30 minutes, the metastatic status of a whole LN. In recent years, some groups have investigated OSNA in patients with CRC and described it as a reliable method for improved staging of lymphatic metastases in CRC, with reported upstaging rates of 20-25% [8,9].

The long-term prognostic significance of all these new ultrastaging and upstaging techniques in CRC patients has, until now, not yet been fully investigated. Gaining this information could be important as upstaging and ultra-staging could also lead to overtreatment. Therefore, it is of critical importance to study the long-term value of these techniques. The objective of this study is to investigate the prognostic value of OSNA and IHC in ex vivo detected SLNs of stage I&II (H&E node negative) colon cancer patients.

Materials and methods

Patient Selection

For this retrospective follow-up study, patients with stage I&II colon cancer were identified from two previously conducted cohort studies [8]. Patients underwent standard oncological resection between November 2008 and December 2013 at two different centers, Jeroen Bosch hospital (JBH), ‘s Hertogenbosch and Leiden University Medical Center Leiden (LUMC). Stage III patients, T0 patients and high-risk stage I and II patients that had received adjuvant systemic chemotherapy (i.e pT4 tumor, poorly differentiated histology, presence of lymph vascular invasion, localized perforation and bowel obstruction) were excluded from this study. All other exclusion criteria were reported in the previous study [8].

Sentinel Lymph Node Mapping Pathological Examination and OSNA-Procedure

SLN mapping was performed ex-vivo within 15 minutes of resection. In patients operated at the JBH, SLN mapping was performed using Patent blue, whereas SLN mapping in the LUMC was performed using indocyanine green (ICG) and near-infrared light. The patent was injected submucosally and circumferentially around the tumor. In both centers the first three colored lymph nodes were marked as SLNs. The SLNs were processed in the same way in both hospitals as previously described [8]. In brief, the SLNs were cut into 4 pieces and labeled a, b, c and d. Slices a and c were pooled together and analysed using OSNA, and slices b and d were subjected to an intensive multilevel sectioning histologic workup, cut into 4 levels with 250μm between each level, with H&E and immunohistochemistry (anti-Pancytokeratin) [8]. The methods used for OSNA analysis are described in the instrument IFU and reagents package inserts [11,12]. Colon cancer was staged according to the 7th version of the TNM classification system [13]. The SLN’s were examined for the presence of tumor cells. All lymph nodes free from metastasis were judged node negative. Sentinel lymph nodes with at least 1 observed tumor cell detected with immunohistochemistry or >250 mRNA copies/μL in the OSNA analysis were judged as positive. A distinction in macro-metastasis [>2mm], micro-metastasis [ >0.2 and ≥ 2 mm] and isolated tumor cells (ITC) [≤ 0.2mm] was made for H&E and IHC [14]. Importantly, only results of the conventional H&E staging were used in clinical practice for interdisciplinary tumor board decision making.

Follow Up

Follow up data were collected retrospectively from the hospital related clinical charts with a median follow up of 50 months. Disease free survival was defined as absence of local or distant metastatic disease diagnosed with the use of computed tomography, MRI or biopsy. Standard follow up examinations were performed using the Dutch oncological follow-up guidelines for colon cancer after curative colon cancer resection [15].

Statistical Analysis

Statistical analysis was performed using SPSS version 23 (SPSS: An IBM Company, Chicago IL). Continuous variables were compared with the Student’s t, Mann-Whitney, one-way ANOVA and Kruskal- Wallis tests, where appropriate. Differences among proportions derived from categorical data were compared using the Fischer’s or the Pearson chi-square tests, where appropriate. All p values in the univariate analyses were two-sided and considered statistically significant if p ≤ 0.05. Cumulative survival was calculated with the Kaplan-Meier function and comparison were performed with Log Rank test. The COX regression model was used to identify the adjusted hazard ratio of survival for patients with OSNA and IHC workup. Data are presented as mean (SD), median (IQR), and HR (95% CI) where appropriate.

Results

Baseline characteristic

A total of 94 patients were included in the present analysis. Of the conventional H&E negative patients, in four patients there was no tumor present (T0) and to 4 node negative patients featuring high risk factors adjuvant systemic chemotherapy was given who were also excluded. Follow-up was successfully completed in all 86 patients with a median follow up of 50 months (SD:13,31). Baseline characteristics are shown in Table 1.

Oncological Follow Up

During the follow-up period 16 patients died of whom three patients died due to cancer related progressive disease. In 10 patient’s death was not cancer related – in four the cause of death was not further specified, one patient died due to postoperative complications, four dues to another malignancy and one patient due to a cerebro-vascular insult. In three patients the cause of death was unknown. Overall, the mean overall survival (OS) was 61.6 months. During the follow-up period 11 of 86 (12.8%) pN0 patients had tumor recurrence. Overall, mean disease-free survival (DFS) was 62.2 months (95%CI= 58.4-66.1months). Distant recurrences were localized in the liver (N= 6), lung (N= 4), skin (N=1) and brain (N=1). Four patients had distant metastasis at two different places at time of diagnosis. Local regional recurrence was localized in lymph nodes (N=3).

Prognostic Significance of OSNA and IHC in Ex Vivo SLN

A total of 18 patients were node positive by OSNA analysis and 68 OSNA-negative. With the use of multilevel sectioning with immunohistochemistry (IHC) 30 patients were node positive and 54 IHC-negative. Two patients had missing IHC data. In the IHC node positive patients micro-metastases were found in 2 patients and isolated tumor cells in 28 patients. Recurrence occurred in 2 of OSNA-positive patients vs 9 of OSNA-negative patients and in 5 of IHC-positive patients vs 6 of IHC-negative patients (Table 2). No significant difference in mean DFS for OSNA-positive vs OSNAnegative patients was observed (62.5 months vs 62.0 months (p=0.886)). Also mean DFS for IHC-positive vs IHC-negative patients showed no significant difference (58.1 months vs 62.9 months (p=0.519). Survival data is shown in Table 3 and figure 1a,b &2a,b. The prognostic independence of OSNA and IHC was tested with cox regression analysis. A positive-OSNA status was not associated with significant shorter disease-free survival, (Hazard ratio [HR]= 0.89, 95%CI=0.19-4.14, p=0.886). A positive-IHC status was also not associated with significant shorter disease-free survival, (Hazard ratio [HR]= 1.47, 95%CI=0.45-4.83, p=0.522).

Discussion

Our study is one of the first published study investigating the prognostic value for disease free survival of OSNA in the long-term follow-up of ex vivo detected SLNs of a small group of stage I&II colon cancer patients, showing no additional prognostic value. Whilst OSNA analysis and IHC can lead to upstaging of early colon cancer patients as described by Vogelaar et al, positive OSNA or IHC status of the ex vivo detected SNLs were no independent predictors for disease free survival in stage I&II colon cancer patients [8]. Therefore, these new upstaging techniques does not provide a more accurate prognostic value. However, the strength of evidence of these findings might be limited because of the reduced power of this study, since this study consisted of a small group of patients. Therefore, the value of these findings must be proven by a bigger study to set these results in a broader perspective. On the contrary, just recently, Itabashi et al. published a 3-years follow-up study of stage I-III CRC patients with sub-analyses in a small group of 70 stage II patients. Showing a significant worse prognosis for stage II OSNA-positive patients [16]. However, 55% of the OSNA-positive and 22% of the OSNA-negative patients were treated with chemotherapy. Since we corrected for this confounder the results of both studies are not comparable. Furthermore, we believe that our study demonstrates more representative results since chemotherapy influence survival outcome. The above shown discrepancy in OSNA-positive SLNs and SLNs harboring micro metastasis with IHC suggests that the OSNA cut-off value for micro metastasis (> 250-5000 copies of mRNA) is maybe not accurate enough to make a prognostic distinction between positive and negative LN status in stage I&II colon cancer patients [11-17]. New studies in breast cancer patients showed a more accurate cut-off value (> 2500 copies of mRNA) for the detection of micro metastases as a prognostic cut-off value, supporting this suggestion [17,18]. Therefore, it is likely that some LNs harboring ITCs are staged as positive nodes with the OSNA analysis leading to upstaging without clinical prognostic relevance, which is in line with some previous studies showing the prognostic value of micro metastasis but not of ITCs [4-20]. The strength of evidence of this study might be limited because of the combination of datasets from two different hospitals. However, both hospitals used the same protocol for the work up of the LNs and OSNA analysis. Although the type of marker used to detect the SLNs was different between the two hospitals, previous studies have shown that there is a high correlation between these different makers, and therefore it is very likely that this difference did not affect the detection rates [21]. Besides the OSNA cut-off value, the prognostic value of total tumor load (TTL) is recently investigated in breast cancer patients [22]. TTL is defined as the total number of CK19 mRNA in all OSNA positive SLNs [22]. These studies demonstrated that a TTL of > 15.000 mRNA is a new tool to predict the metastatic involvement of non-sentinel axillary nodes [22]. This new intra-operative tool could be of interest in early colon cancer patients when, in the future, more minimally invasive surgery will be performed. However, this data is not yet available in colon cancer patients and therefore further research is needed.

Furthermore, it is noteworthy that almost all disease recurrences seem to be of haematogenic nature. This metastatic pattern, the knowledge that 20-30% of stage I&II patients suffer from disease recurrence within 5 years after surgery and above mentioned results could suggest that LN assessment has less clinical value in stage I&II CRC patients than expected [4,5]. Another alternative that has been investigated in recent years is the prognostic value of tumor specific histopathological characteristics in these patients. Some of these characteristics of interest are tumor budding, poorly differentiated clusters and peri-neural invasion. Literature regarding these tumor specific histopathological characteristics is not unambiguously, but seems to have prognostic value in defining high risk stage I&II CRC patients [23,24]. Besides histopathological characteristics, several molecular biomarkers for stage I&II CRC patients have been studied in recent years, of which microsatellite instability (MSI) and mutations in the KRAS, BRAF and PIK3CA genes are the most wellknown biomarkers [25]. The prognostic value of these biomarkers in stage I&II CRC patients is not yet determined. However, recent studies show that these biomarkers might be valuable in staging I&II CRC patients [25]. Further research is therefore necessary to identify other clinically relevant upstaging techniques or molecular biomarkers and histopathological prognostic factors to improve the treatment of stage I&II CRC patients. In conclusion, this study demonstrated that OSNA-and IHC-analysis of ex vivo detected SLNs does not provide a more accurate prognostic value for disease free survival in a small group of patients with non-metastasized colon cancer compared with the conventional H&E. However, a bigger study is needed to set these results in a broader perspective. Further research is required to identify other clinically relevant ultra-staging and upstaging techniques or molecular biomarkers and histopathological prognostic factors to identify high risk stage I&II CRC patients, to improve the prognostic assessments and tailor the treatment plans.

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Lupine Publishers | The Effect of two Surgical Approach Lordosis Correction in Degenerative Lumbar Diseases: Minimally Invasive Oblique Lumbar Interbody Fusion (OLIF) Versus Transforminal Lumbar Interbody Fusion (TLIF)

 Lupine Publishers |  Orthopedics and Sports Medicine

Abstract

Background: The present study aimed to compare clinical outcomes and radiographic results of oblique lumbar interbody fusion (OLIF) with transforaminal lumbar interbody fusion (TLIF) in patients with lumbar spondylolisthesis.

Methods: We retrospectively reviewed and compared 28 patients who underwent OLIF (OLIF group) and 35 who underwent TLIF (TLIF group). The operation time, intraoperative hemorrhage, bed rest duration, and length of hospital stay were compared between the 2 groups. Clinical results were evaluated with the ODI and VAS for back and leg pain. Radiological results were evaluated with disc height (DH), foraminal height (FH), fused segment lordosis (FSL) and lumbar lordosis (LL).

Results: The OLIF group had less intraoperative blood loss, shorter operative time, bed rest time, and hospital stay than TLIF group (P<0.05). The OLIF group had lower VAS scores for back pain and lower VAS scores for leg pain after surgery compared with before surgery (P<0.05), The OLIF group had lower ODI after surgery compared with before surgery (P<0.05) .The was no significant difference in decrease value in VAS and ODI after surgery between the two groups (P>0.05). No significant differences were found in DH, FH and LL between the 2 groups preoperatively (P>0.05). The OLIF group showed higher DH and FH than the TLIF group at all time points (P<0.05). No significant differences were found in FSH between the 2 groups at any time point.

Conclusions: OLIF has similar good long-term clinical outcomes of TLIF with the additional benefits of less initial postoperative pain, early rehabilitation, shorter hospitalization, and fewer complications.

Keywords: Lumbar Spondylolisthesis; Oblique Lumbar Interbody Fusion; Transforaminal Lumbar Interbody Fusion; Sagittal Balance

Introduction

Lumbar spondylolisthesis describes a forward displacement of a lumbar vertebra. The most common types are degenerative or isthmic lumbar spondylolisthesis. It is a common pathology, often causing lumbar canal stenosis. Symptoms of lumbar spondylolisthesis may include intermittent neurogenic claudication, lumbar radiculopathy and back pain [1]. The primary treatment for lumbar spondylolisthesis is non-surgical. When unsuccessful, surgery can be considered in order to decompress neural structures and stabilize the spine. Lumbar fusion has become an accepted treatment to treat degenerative diseases of the lumbar spine. There is a growing body of evidence that consistently demonstrates improved clinical outcomes with lumbar fusions for patients who fail conservative care [2]. Transforaminal lumbar interbody fusion (TLIF) is one of the widely used techniques for spinal fusion. The first attempt for TLIF was by Harms and Rolinger, who reported on the use of bone graft packed in titanium mesh that was inserted via a unilateral transforaminal route into the anterior part of the disc space. Harms and Blumes developed the TLIF technique further, and Harms described this in detail together with Jeszensky in 1998 [3-5] It is a posterior approach that uses a facetectomy corridor and has benefits of safety, good outcomes, and high fusion rate. Surgeons prefer this approach because they can reduce dural retraction and enable direct neural decompression. However, characteristic complications include posterior spinal muscle injury and cerebrospinal fluid (CSF) leakage [6, 7]. The OLIF was first described by Mayer et al in 1997, and the term was later coined by Silvestre et al in 2012. This approach aims to avoid the morbidity of the transpsoas approach by translating the incision anteriorly and dissecting around the psoas [8, 9] Oblique lateral interbody fusion (OLIF) is a new technique in spine surgery, through oblique lateral retroperitoneal approach, it can establish a work corridor direct access to the intervertebral space between the psoas muscles and the abdominal vessels sheath. Through the retroperitoneal work corridor, OLIF can complete intervertebral fusion of anterior and middle column, restore the height of intervertebral space and foramen, and make the spinal canal or nerve root indirect decompression. OLIF is applicable to degenerative lumbar spine diseases, spinal tuberculosis, tumor, kyphosis, postoperative renovation and trauma, etc. OLIF conforms to the current trend of minimally invasive spinal surgery, which has many advantages like less surgical trauma, less surgical bleeding loss, shorter hospital stay, faster recovery, less damage to the abdominal organs, no stimulation of the spinal nerve and less damage to the psoas and lumbosacral plexus [10-12]. The aim of this study was to compare OLIF and TLIF for the treatment of lumbar spondylolisthesis in terms of clinical outcomes and radiographic results.

Methods

Patients

The study enrolled patients who underwent TLIF (TLIF group) or OLIF (OLIF group) in our department between January 2018 and October 2019. The surgery apporach was deteminated by the patien’s desirement. The inclusion criteria were as follows: all patients were operated for a single lumbar level and they had complaints of low back pain and lower limb pain unresponsive to conservative therapy for over 3 months, radicular symptom and/ or intermittent claudication before the operation. Preoperative examination included a detailed physical examination and radiological imaging. Patients with previous spinal instrumentation, spinal tumor pathologies, spinal infections, and acute spinal trauma or fractures were excluded. Among them, 28 patients underwent OLIF (OLIF group) and 35 patients underwent TLIF (TLIF group). The health records and radiographic data of the 64 patients were summarized and analyzed. This study was reviewed and approved by the Ethics Committee of the First Affiliated Hospital of Soochow University.

Operative Procedure

Oblique lumbar interbody fusion

After induction of general anesthesia, the patient was placed in lateral decubitus position on the right side. The operating segment was marked on the skin via a C-arm machine. A 5 cm skin incision was made on the marked disc level at the left abdomen. Then carry out blunt finger dissection of the abdominal oblique muscles, which includes the external oblique, internal oblique, and transversalis abdominis muscles. The surgeon uses the index finger to confirm the anterior border of the psoas muscle, sliding from the quadratus lumborum muscle to reach there. The retroperitoneal space was accessed by blunt dissection, and the peritoneal content was mobilized anteriorly. Place a Kirschner wire into the disc space from the antero-laterl corner to confirm the target disc space again. Sequential dilators were placed over the Kirschner wire. After the final tubular retractor was placed over the anterior onethird of the disk under illumination, the entire visualized area was made clearly. A lateral annulotomy was performed followed by a complete discectomy by using pituitary rongeurs and curettes, then removing the focus by using curette. After that, an appropriate-sized cage filled with autologous bone graft was inserted orthogonally in a press-fit fashion into the disc spaces. The above procedures were done step by step under C-arm fluoroscopic guidance. After completing the anterior procedure, the patient was turned to the prone position, and supplemental posterior instrumentation was then placed with a midline incision to sustain the stability of spine.

Transforaminal lumbar interbody fusion

After induction of general anesthesia, the patient was placed in a prone position on a carbon table. Then mark the target level under the C-arm guidance. A midline incision was made. The skin and subcutaneous tissue were incised layer by layer and the paravertebral muscles were dissected from the spine. Pedicle screw-rod was inserted bilaterally. The facet joint and part of the vertebral lamina were removed by osteotome and the disk was then removed. After resection of ligamentum flavum and osteophyte, a cage filled with autologous bone was inserted in the disc space. The wound was copiously irrigated and closed in layers.

Assessment of Clinical and Radiographic Outcomes

The duration of the operation, volume of intraoperative hemorrhage, length of bed rest, length of hospital stay and complications were recorded for all patients. Clinical and radiographic outcomes were evaluated preoperatively and at 1 week, 3 months and 6 months postoperatively. We used the visual analog scale (VAS) for leg pain (VAS-LP) and back pain (VAS-BP) and the Oswestry Disability Index (ODI) to compare clinical outcomes between the two groups. Lumbar lordosis (LL), disc height (DH), foraminal height (FH), LL was defined as the angle between the upper endplate of the L1 and S1 vertebra using the Cobb method. DH was calculated as the mean value of the anterior and posterior margin heights of the affected disc. FH was measured as the maximal interval between the lower border of the upper pedicle and the upper border of the lower pedicle. Two observations were made at an interval of at least 2 weeks by two neurosurgeons, and the mean values were used for the study.

Statistical Analysis

The data analysis were performed by Statistical Package for the Social Sciences (version 19.0 SPSS, Chicage, IL) and Microsfot Excel 2016 (Microsoft, Seattle, WA). All quantitative variables are presented as means±standard deviations. Student’s t-test and the chisquared test were used to compare radiological and clinical outcomes of OLIF and TLIF. The difference between the two groups were assessed by using Chi-square test. P<.05 was considered statistically significant.

Results

No significant differences were found between the 2 groups in terms of baseline patient characteristics, including age, sex, body mass index and operated levels (Table1). The operative duration was shorter and intraoperative hemorrhage was less in the OLIF group compared with the TLIF group (186.44±36.5 vs. 199±59.64min; 55.94±57.37 vs. 190±66.33mL; respectively). The OLIF group had a shorter bed rest time and shorter hospital stay than did the TLIF group (P<0.05) (Table1). VAS scores of both groups decreased postoperatively (Table2). No significant differences in VAS（BP）scores were found at preoperative and postoperative 3 months between the 2 groups (P>0.05). Statistical difference was found at 1 week after surgery (P<0.05). No significant differences in VAS（LP）scores were found at any follow up time. Preoperative ODI were 54.88±8.13 and 53.93±6.06 points in the OLIF and TLIF groups, respectively (P>0.05), which both decreased postoperatively. No significant differences in ODI scores were found at preoperative and postoperative 3 months between the 2 groups (P>0.05). Statistical difference was found at 1 week after surgery (P<0.05). No significant differences in DH and FH between the 2 groups were seen preoperatively (P>0.05). The postoperative FH and DH was significantly greater than the preoperative value in each group (p<0.01). The postoperative DH was significantly greater in the OLIF group than in the TLIF group (p<0.01). The postoperative FH and DH was significantly greater than the preoperative value in each group (p<0.05). The OLIF showed higher DH and FH than the TLIF group at all time points after surgery (p<0.05). There was no statistically difference found in LL between the two groups before surgery (P > 0.05), but the recovery of LL in OLIF group was significantly greater than that in TLIF group (P < 0.05). Both groups showed increased FSL after surgery, while no significant differences in FSL were found between the 2 groups at any follow-up time point (Table 3). For patients in TLIF group with a combination of supplemental fixation at a given level, there was 8.6% (3 of 35) rate of cage subsidence. Of the 3 patients with radiographical subsidence, only 1 was symptomatic. Besides, for patients in OLIF group with a combination of unilateral fixation, there was 7.1% (2 of 28) of cage sedimentation. In OLIF group, two patients showed ileus on the first postoperative day which improved spontaneously the next several days. One patient experienced thigh and numbness postoperatively, which alleviated within 7 days after surgery. There was no ureteral injury or lesion to sympathetic chain. In the TLIF group, CSF leakage due to thecal sac injury and root injury was confirmed in three cases. The drainage tube was removed 7 days after the operation. Superficial incision infection occurred in 3 patients in the TLIF group, which was treated with dressing change and antibiotics.

Discussion

Lumbar spondylolisthesis is a common pathology accompanied with lumbar canal stenosis, displaying a certain degenerative imbalance and thus presentinga risk factor for degenerative scoliosis in later life. This is due to conservative treatment options being relatively inferior, thus indicating that surgical treatments offer a more meaningful approach [13]. Lumbar fusion has become an accepted treatment to treat degenerative diseases of the lumbar spine [14]. Both PLIF and TLIF are the most widely used posterior fusion techniques, which can fully expose to nerve roots. However, several literatures demonstrated that there is a risk of iatrogenic lesions of the dural sac and nerve roots as well as epidural bleeding in PLIF. For the limitations of PLIF, TLIF was introduced. TLIF is a variant of the PLIF technique described by Cloward in the 1950s [15]. It is usually performed by unilateral approach preserving the interlaminar surface on the contralateral side, which can be used as a site for additional fusion. Compared with PLIF, TLIF retains ligamentous complex, contralateral lamina and facet joints, thus maintaining spinal stability [16-17]. OLIF is a modification of the retroperitoneal approach for microsurgical anterolateral lumbar interbody fusion, which was first described by Mayer in 1997[18]. In this study, we found that the OLIF group had less intraoperative blood loss and shorter operative time, bed rest duration, and hospital stay than the TLIF group. Potentially because of the absence of back muscle injury in OLIF, we also found that the OLIF group had lower VAS scores for back pain and ODI than the TLIF group at 1 week postoperatively. In contrast to transforaminal lumbar interbody fusion, OLIF technique is performed through the retroperitoneal space and accessed by blunt dissection. Both separation of paravertebral and tissue removal of bone mass near the canal are not necessary in procedure. The separation of the paravertebral tissue and the large incision are key reasons that accounts for the high level of intraoperative blood loss and high incidence of postoperative incision complications. Altogether, both OLIF and PLIF display obvious differences in terms of the surgical procedure. Compared with TLIF, OLIF had the advantages of less blood loss, shorter operative time and preservation of the posterior longitudinal ligament complex, which presented as a key reason in affecting post-operative efficacy. It has been reported that no significantly improvement was found in lumbar lordosis in TLIF [19]. However, the lumbar lordosis (LL) recovered significantly in both groups in our study. We noted that the TLIF was effective in restoring normal lumbar lordosis, which is probably because that we place the interbody graft as anterior as possible to maximize the lordotic potential, and it is within the construct in combination with compression from the posterior column. Other studies show that the effect of TLIF in restoring normal lumbar lordosis depends on compression of posterior structure of the lumbar vertebrae [20]. Several literatures demonstrated that LL is restored well in lateral lumbar interbody fusion. Thus far, we expect that OLIF will do better in deformity correction. Luckily, differences were found in LL in two groups after surgery. In OLIF group, the mean improved Cobb angle is larger than that of TLIF, demonstrating that the correction in lumbar lordosis is better in OLIF. Kepller et al. demonstrated that more lumbar lordosis was associated with more back and leg pain as assessed by VAS [21]. Fujibayashi demonstrated that clinical results are related more to the effect of deformity correction than to indirect neural decompression [13]. This may be explained that why the VAS scores is less in OLIF group after the surgery. In addition, restoration of DH in the fusion segment significantly improved the compression of nerve canal by reduction of disc bulging and elongation of the hypertrophied ligamentum flavum. Both surgical procedures increase DH of the diseased segment. Moreover, the OLIF group showed higher restoration of DH and FH than TLIF group postoperatively. This is reasonable, because we inserted a relatively larger cage into the target disc in OLIF. The height and width of OLIF cage are 8-14 mm and 55 mm respectively while the cage in TLIF is 8-12 mm in height and 30 mm in width [23]. The height of intervertebral can be increased by using larger and wider cage, the same as intervertebral foramen height and vertebral canal area. The wide cage allows it to rest on the hard epiphyseal ring around the vertebral body, rather than on the relatively weak area of the cortical bone in the central depression of the endplate.

For patients in TLIF group with a combination of supplemental fixation at a given level, there was 8.6% (3 of 35) rate of cage subsidence. Of the 3 patients with radiographical subsidence, only 1 was symptomatic. Besides, for patients in OLIF group with a combination of unilateral fixation, there was 7.1% (2 of 28) of cage sedimentation. It may prove that the effect on avoiding subsidence in unilateral fixation is good enough. Besides, as mentioned by Tien V, the inferior endplate is 40% stronger than the superior endplate [24]. In 5 cases of our study, the cage was inserted superior endplate, which did consistent the theory mentioned above. In the current reports, the complication rates of TLIF were range from 7.1 to 21.6% [25-29] including rod-broken and cage migration. The complication incidences of OLIF were varied in literatures, ranging from 3.7% to 58.3% [13-31]. Ohtori et al. demonstrated that segmental artery injury occurred in 1 patient and the surgery was converted to open surgery. Zeng et al. reported that the complication incidence of OLIF was 13.62%, such as cerebral infraction and reoperation, both of which were only one case. Except for several serious complications mentioned above, the rest are all transient symptoms. In this study, two patients who underwent OLIF showed ileus on the first postoperative day. The postoperative ileus improved spontaneously in the next several days. One patient experienced thigh and numbness postoperatively in the OLIF group, which alleviated within 7 days after surgery. There was no ureteral injury or lesion to sympathetic chain. In the TLIF group, CSF leakage due to thecal sac injury and root injury was confirmed in three cases. The drainage tube was removed 7 days after the operation. Superficial incision infection occurred in 3 patients in the TLIF group, which was treated with dressing change and antibiotics. However, several disadvantages can’t be ignored in OLIF technique. In the process of disc removal, repeated fluoroscopy is needed and patients are exposed to more radiation than TLIF. Besides, the larger cage may lead to iatrogenic injury to nerve root, especially to the upper nerve root of the oblique side of the kambin triangle. What’s more, the cage is more expensive than traditional one and some patients in poor family can’t afford it.

Limitations

A limitation of the study was that it was a retrospective study with a relatively small sample size. Moreover, the inclusion criteria were rather restrictive and may have contributed to a selection bias that may have led to an underestimation of incidence rates for nonunion, subsidence, and surgical approach-related complications. The intention is to follow up this study in the future to obtain further information aimed at improving the deficiencies identified in this article. In addition, increase the number of followup cases in an attempt to reduce the error of follow-up data to further improve the accuracy of this study.

Conclusion

Both OLIF and TLIF can achieve satisfactory clinical results in the treatment of lumbar spondylolisthesis accompanied with lumbar stenosis. However, compared with TLIF, a smaller incision, shorter ansthesia time, less blood loss and earlier postoperative activities in OLIF did exhibit a greater advantage, attracting more and more attention in surgeons.

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Lupine Publishers | Neglected Posterior Shoulder Dislocation with a Large Bone Defect in a young Active Patient Treated with Osteochondral Allograft

 Lupine Publishers |  Orthopedics and Sports Medicine

Abstract

Background: Posterior glenohumeral joint dislocation is a rare injury. Despite positive clinical signs is often underdiagnosed and undertreated. The presence of a large bone humeral defect could worsen the outcome.

Case Report: We report a case of 45 years-old man with a neglected posterior shoulder dislocation with a large segmental bone defect involving 40% of the articular surface of the humeral head. We decided to treat the patient with an open reduction of the shoulder dislocation and reconstruction of the articular surface with fresh-frozen humeral head allograft. Our patient showed improved shoulder mobility and ROM on all planes that positively affected the patient daily activities; no pain was registered at follow-ups.

Conclusion: Our case report demonstrates that neglected posterior shoulder dislocations with a large bone defect and viable humeral head can be treated using allograft, obtaining optimal clinical results and avoiding the need for early prosthetic replacement surgery.

Keywords: Neglected Posterior Shoulder Dislocation; Reverse Hill-Sachs Lesion; High-Demand Patient; Humeral Head Allograft; Anatomic Shoulder Restoration

Abbreviations: GHJ: Glenohumeral Joint; MRI: Magnetic Resonance Imaging; MVA: Motor Vehicle Accident; LHB: Long Head Of Biceps Brachii; XR: X-Rays

Introduction

Posterior glenohumeral joint (GHJ) dislocation is a rare injury and accounts for only 2% to 5% of all dislocations of the shoulder [1]. GHJ posterior dislocation has a prevalence of 1.1 per 100,000 inhabitants per year, with the first peak in male patients aged between 20-49 years old, and the second one in the elderly over the age of seventy [2]. Posterior shoulder dislocation is often underdiagnosed and undertreated in up to 50% of cases admitted to the E.R. [3]. A dislocation is defined chronic when left untreated for more than 3 weeks. Diagnosis of posterior GHJ dislocations is often delayed, becoming chronic and leading to a locked joint and decreased functional outcome [4]. Typically, posterior shoulder dislocation can be traumatic or atraumatic: the first might be due to direct high-energy trauma or it can also develop insidiously through a repetitive minor injury. A major trauma with a force applied to the arm with the shoulder in adduction, flexion and internal rotation is the most frequent cause (e.g. A direct blow to the anterior shoulder or by a fall on a forward-flexed upper limb)[5]. On the other hand, seizures and electrocution are the major causes of atraumatic dislocations, by contraction of the internal rotators and disruption of the joint static and dynamic posterior stabilizers [1]. Associated injuries include humeral neck or tuberosity fractures, impaction fractures of the anterior humeral head (i.e. reverse Hill–Sachs lesion), posterior labrum capsular complex lesions (i.e. reverse Bankart lesion) and rotator cuff tears [2, 6]. Reverse Hill-Sachs lesions can be associated with posterior GHJ dislocation in up to 86% of cases, requiring open or arthroscopic surgical therapy [1, 7, 8].

Missed, late or incorrect diagnosis is a significant clinical problem, as it can predispose to serious complications, such as chronic instability, osteonecrosis, post-traumatic osteoarthritis, persistent joint stiffness and functional instability [4, 8]. Treatment management of chronic posterior shoulder dislocation associated with a large articular defect is strongly debated due to lack of studies with significant clinical records: operative treatment is usually preferred based on the type and the extension of injury, age, medical history and functional demand of the patient. The patient gave consent for case report.

Case Report

A 45-year-old deaf man, involved in an MVA, sustained a direct blunt trauma to his dominant right shoulder. The patient was employed as a warehouse worker. At the time of the accident, he has been admitted to the ER of another hospital where he has been discharged with the diagnosis of “right shoulder contusion”. The patient was admitted to our clinic three months after the trauma, complaining severe pain and functional limitation of the right shoulder. At physical examination the patient showed functional limitation of the shoulder motion on all planes, in particular: abduction 30°, flexion 30°, internal rotation at the iliac spine, external rotation 0°. At palpation the shoulder was painful. The patient was neurovascular intact.
X-Ray and CT scan were carried out, showing posterior GHJ dislocation with an osteocartilagineous lesion about 40% of the humeral head surface, localized on its antero-medial edge (a reverse Hill-Sachs lesion; type I according to Randelli’s classification of posterior shoulder dislocation) (Figure 1) [9]. Based on clinical (i.e. not reducible dislocation after conservative treatment) and radiological evaluation (i.e. complete dislocation of the shoulder with important bone loss of the humeral head), the patient was subsequently scheduled for surgery. Considering the young age of the patient, his high functional demand and the extension of the lesion, we decided to perform a humeral head allograft reconstruction. We requested it to the bone bank communicating the size of the humerus of the patient to obtain the best matching allograft. The procedure was performed under general anaesthesia with the patient placed in a beach-chair position. A deltopectoral approach was used with release of the pectoralis major tendon insertion to improve the exposure of the surgical field. After finding and isolating the anterior humeral circumflex artery and vein, the subscapularis tendon was exposed and cut through its insertion. After detaching the subscapularis muscle from the lesser tuberosity, as the long head of biceps brachii (LHB) tendon tended to dislocate from the bicipital groove we decided to tenotomize it. We proceeded to perform lysis of the posterior adhesions and then the posteriorly dislocated locked humeral head was gently reduced with the aid of a Schanz pin inserted in the lateral aspect of the humeral shaft used as a joystick. Subsequently a large 40% reverse Hill–Sachs lesion was exposed. With an appropriate burr, an accurate regularization of the Hill-Sachs lesion was made, obtaining a viable bony surface. The fresh-frozen humeral allograft was then carefully prepared aside to obtain an anatomic restoration of the cephalic anatomy. The size-matched osteocartilaginous allograft was press-fit into the humeral defect and fixed with 3 4.0mm lag screws reaching a stable construct – (Figure 3). The subscapularis tendon was reinserted by two anchors (JuggerKnot® SoftAnchor - 2.9 mm, Zimmer-Biomet, Jacksonville, FL, USA), (ALLthread™ Suture Anchor – 5mm Zimmer-Biomet, Jacksonville, FL, USA), on his anatomical site. The LHB was sutured on the pectoralis major tendon with non-absorbable suture. The arm was kept in a 30° of abduction and 30° of external rotation using a shoulder brace for 4 weeks post-operatively. Passive range of motion was started at 4 weeks following surgery and active range of movement was started 6 weeks post-operatively. A shoulder CT scan was performed at 1-year follow-up showing no signs of allograft bone resorption, screw loosening or avascular necrosis (Figure 4 A-B). Also 1 year after surgery the patient reported no painful symptoms showing excellent ROM on all planes (Figure 5 A-D); he was able to perform normal daily and work-related activities. A 95 points Constant- Murley Score was recorded at this time.

Discussion

The aim of this paper is to present the clinical results using a fresh-frozen osteochondral humeral head allograft in a young active patient affected by a chronic GHJ dislocation with reverse Hill-Sachs lesions about 40%. Scientific literature shows scarce consensus about the treatment of this rare injury: there is an ongoing debate about the different treatment options. Moreover there is not an agreement on the best allograft that has to be used. The reverse Hill-Sachs lesion size is the most influencing factor for choosing the type of treatment [3]. The reverse Hill-Sachs (also called McLaughlin lesion) is a wedge-shaped impaction fracture on the antero-medial aspect of the humeral head [7]. Any significant lesion should be treated operatively [8]. According to Guehring et al., for defects involving less than 25% of the articular surface closed reduction is the first choice of treatment; patients with unstable joints and bone defects >25% could benefit of operative treatment, with arthroplasty being recommended if the bone defect is >40% [9,10]. For defects between 25% and 40% a plethora of treatment modalities can be adopted including the classical or the modified McLaughlin technique, bone grafts, etc. [11.12]. In our patient, we opted for a humeral head allograft to obtain an anatomic restoration. We preferred this procedure to non-anatomic procedures as subscapularis tendon transfer (i.e. classic McLaughlin) or the lesser tuberosity transfer (i.e. modified McLaughlin) because, according to authors, a non-anatomic restoration of the humeral head sphericity can lead to a decreased internal rotation of the shoulder and can complicate a foreseeable prosthetic reconstruction [3, 4, 5]. Our patient had borderline indications for hemiarthroplasty. Considering his relatively young age and global clinical assessment, we decided to perform an allograft procedure to respect the patient’s high functional demand of the affected limb. Furthermore, we agree with authors which alert on the difficulty to manage the moderate-sized Hill Sachs lesions (i.e. sizing between 40-55%), even for experienced shoulder surgeons: young and middle-aged individuals with high functional demand can benefit of a delay in the hemiarthroplasty surgery by preserving the sphericity of the humeral head [6]. Concerning the graft type, most literature focus on cancellous allograft or autograft to treat acute posterior shoulder dislocation. These grafts are used as a void filler after lifting off the previous impacted articular surface to better stabilized the lesion gap and promote bone healing [1]. For defect between 25% and 40% some authors report reconstruction of the articular surface with fresh-frozen osteochondral allograft [1, 5, 13, 22, 23]. No specific guideline has been proposed for the choice of the allograft. Some authors used a fresh-frozen femoral head allograft. In particular, authors report good functional outcomes using a femoral head allograft for treating locked chronic posterior shoulder dislocation in patients having 25-50% articular surface bony defects [5,13]. The same good results are described in a case report by Patrizio et al. [22]. The most frequent possible complications recorded with this procedure are graft resorption, articular surface flattening and arthritis [5, 13]. Other authors. Proposed the use of a fresh-frozen talus allograft in case of limited accessibility of humeral head graft. They described a similar congruency between the radii of curvature observed with the taller dome and with the humeral head, allowing for application to broader category of patients [23].
The use of fresh-frozen humeral head allograft has been described by Martinez et al. in 5 patients affected by GHJ instability after posterior GH dislocation and in 1 patient with chronic GH dislocation. All patients had a 40% humeral defect. The study had a follow-up period of 10 years; 4 patients had satisfying outcomes while 2 suffered collapsing of the graft [1]. When comparing our case with the aforementioned paper, we obtained from the bone bank an accurate sized humerus matching the patient’s one. By doing so we were able to better fill the gap and restore the precise curvature of the humeral head of the patient, rather than with the use of femoral head, achieving an anatomical restoration. By filling the defect using a humeral head allograft we aimed at preserving both shoulder stability and function, while maintaining the integrity of anatomic soft tissue attachments and preserving the remaining articular surface. Our case report showed how operative treatment options must be patient-targeted according to each intrinsic factors (e.g. age, functional demand, comorbidities, etc.), to the type of injury (e.g. extension of bone defects) and its severity [14, 15]. Our patient had a high functional demand influencing his work-related activities and reported consistent pain for up to three months. Patients with posterior GHJ dislocation suffer a diagnosis delay and often report aspecific symptoms during healthcare evaluation [16, 17]. Our patient as well had aspecific symptoms; apart from significant pain and loss of motion, patients with chronic GHJ dislocation may show shoulder muscle atrophy and prominent acromion on the opposite side, while the dislodged humeral head can be palpated on the back of the shoulder [18]. XR findings can mislead clinicians as the AP view could show no sign of posterior GHJ dislocation: axillary-lateral or Y views (hard to obtain if consistent pain is present), CT scan and/or, as in our case, an MRI can unmask the dislocation [7, 19]. Diagnosis delay pivots the treatment: in a case series study it is highlighted how patients promptly treated for acute dislocation have a better outcome and are easier to treat [20]. During follow-up, our patient has undergone rehabilitation therapy; post-operative recovery consists of strengthening exercise neuromuscular re-education, while educating the patients to avoid flexion, adduction and internal rotation movements [19, 21]. We acknowledge the limitations of this paper due to limited follow-up.

Conclusion

Posterior GHJ dislocation greatly benefits early diagnosis. If a reverse Hill-Sachs lesion is associated, there is the need of standardized treatment protocols for management of this condition. An important limit we faced when searching the literature is the paucity of studies with a large number of cases treating GHJ dislocation with a reverse Hill-Sachs lesion: we strongly recommend for future studies to unveil possible benefits and limitations, especially involving the benefits of bone grafts. We want to emphasize the importance of preserving the GHJ anatomy in the young, active patient by delaying prosthetic replacement only once necessary. We want to point out how, even if the graft procedure fails there is still the possibility to proceed with a salvage procedure (i.e. prosthetic replacement), that will be found easier to perform over a preserved humeral head anatomy.

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