Facet joint fusion by thermal ablation for single-level lumbar spinal stenosis

doi:10.21203/rs.3.rs-4270713/v1

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Facet joint fusion by thermal ablation for single-level lumbar spinal stenosis

https://doi.org/10.21203/rs.3.rs-4270713/v1

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Previous studies demonstrated the presence of bridging bone across the facet joints in postoperative computed tomography (CT) scans of patients who underwent unsuccessful posterior lumbar fusion (PLF) and interbody fusion (IBF) procedures. Recent research shows that facet joint fusion achieved through bone grafting with pedicle screw instrumentation leads to satisfactory clinical outcomes and fusion rates. Building upon these findings, there is a hypothesis that facet joint fusion achieved solely through thermal ablation, without the need for bone grafting, may yield credible fusion rates and clinical outcomes. A retrospective review was conducted on 136 patients who underwent lumbar fusion utilizing thermal ablation of the facet joint. CT and clinical outcomes, including Visual Analog Scale (VAS), Japanese Orthopaedic Association (JOA), and Oswestry Disability Index (ODI), were evaluated both preoperatively and at the 6-month, 1-year, and 2-year follow-up intervals. At the final assessment, 90.4% of patients achieved excellent or good results, and no technique-related complications were observed in any of the patients. We believe that the compelling clinical outcomes and fusion rates achieved through thermal ablation of the facet joint highlight its potential as a highly feasible alternative method for treating single-level lumbar spinal stenosis, which potentially replaces traditional interbody fusion (IBF) techniques.

Facet Joint Fusion

thermal ablation

single-level lumbar spinal stenosis

lumbar fusion surgery

fusion rate

Spinal fusion represents a cornerstone in the surgical management of various spinal conditions, including single-level lumbar spinal stenosis. Commonly utilized techniques such as posterolateral fusion and posterior lumbar interbody fusion are instrumental in addressing lumbar pathologies, often necessitating bone grafting. Over decades, iliac crest autografts and allogeneic bone have remained staples in lumbar fusion procedures¹.

However, post-surgical complications, notably pseudoarthrosis and donor site issues, pose significant challenges. Over the past two decades, there has been a growing recognition of pseudoarthrosis as a major concern, particularly with the rising number of spinal fusion cases^2–4. Despite advancements in spinal fusion techniques and an increase in the number of patients undergoing fusion surgery, pseudoarthrosis has emerged as a predominant complication, profoundly impacting clinical outcomes. Fusion failure not only diminishes the effectiveness of instrumentation, thereby adversely affecting clinical outcomes, but also necessitates revision surgery⁵, escalating patient costs and imposing a burden on healthcare systems.

While the development of lumbar instrumentation has substantially improved fusion rates, the occurrence of pseudoarthrosis post-lumbar fusion remains a significant concern. In recent decades, various fusion techniques have emerged, with posterolateral fusion (PLF), posterior lumbar interbody fusion (PLIF), and transforaminal lumbar interbody fusion (TLIF) being the most commonly performed^6,7. PLF, involving intertransverse process fusion with pedicle screw instrumentation, exhibits lower fusion rates compared to PLIF. Additionally, PLF's aggressive approach to paravertebral muscles has been associated with poor postoperative outcomes, including residual low back pain⁸.

However, PLIF requires bone grafting across the spinal canal, which carries the risk of spinal canal damage⁹. TLIF, on the other hand, entails the removal of unilateral facet joints to access the intervertebral space, potentially compromising the posterior spinal column and increasing blood loss. Moreover, TLIF demands high technical proficiency from the surgeon¹⁰.

In conclusion, while advancements in spinal fusion techniques have improved outcomes, each approach presents its own set of advantages and limitations. Tailored treatment strategies based on individual patient needs and surgical considerations remain paramount in optimizing clinical outcomes.

Facet joint fusion has garnered significant attention in recent years, given that facet joints are the sole synovial joints in the spine¹¹. A distinctive feature of synovial joints is the replacement of articular cartilage with bone after joint immobilization¹². This phenomenon elucidates why bridging bone has been observed across facet joints in postoperative computed tomography (CT) scans of unsuccessful posterior lumbar fusion (PLF) and interbody fusion (IBF) patients¹³. In a recent study, Ren ZN et al. demonstrated that facet joint fusion achieved through bone grafting with pedicle screw instrumentation led to satisfactory clinical outcomes and fusion rates¹⁴. Consequently, facet joint fusion emerges as a viable alternative to procedures like transforaminal lumbar interbody fusion (TLIF) and PLF.

However, traditional fusion techniques are associated with common drawbacks such as complex procedures, significant bone graft requirements, and substantial invasiveness. These disadvantages contribute to prolonged surgery duration, increased blood loss, and heightened risks of postoperative complications. Hence, we propose thermal ablation of the facet joint for facet joint fusion without the need for bone grafting. If proven effective, this technique holds promise as a less invasive fusion surgery method. This article aims to evaluate the clinical outcomes and fusion rate of thermal ablation in facet joint fusion.

Patient population

A total of 136 patients were admitted to the Spinal Surgery Department at Shengjing Hospital between 2020 and 2023, comprising 62 male and 74 female patients, all diagnosed with single-level lumbar spinal stenosis. The patients, aged between 19 and 80 years old, with an average age of 55.2 years, presented with varying degrees of lower back pain, neuropathic pain of the lower limbs, or intermittent claudication.

In total, 272 facet joints were operated on, all by the same surgeon, using posterior lumbar fusion via thermal ablation of the facet joint, with pedicle screw instrumentation. Prior to surgery, all patients underwent comprehensive CT and MRI examinations to confirm the diagnosis and ensure appropriate treatment planning.

Inclusion and exclusion criteria

Inclusion criteria are as follows:

1.patients with single-level lumbar spinal stenosis;

2.conservative treatment failed for more than 3 months;

3.underwent facet joint fusion by thermal ablation only;

4.2-year follow up data available postoperatively.

Exclusion criteria are as follows:

1.spondylolysis;

2.scoliosis;

3.revision surgery;

4.multiple-level lumbar spinal stenosis.

Surgical technique of thermal ablation

We take the standard posterior midline approach for all the patients, all of which were operated by the same surgeon. Then spinal process, lamina, articular process and facet joint was dissected subperiosteally. After that we ablate the capsule around the facet joint with Surgical electrotomy. The articular cartilage can be removed completely through the electric current and heat which is generated by the Surgical electrotomy. This procedure is what we called thermal ablation. (Figure 1).

Once the cartilage was removed and the subchondral bone exposed, we can create a bed where bone trabecula can grow on. And the soft tissue around the facet joint should be ablated completely too, which was meant to enlarge the bed, facilitating the fusion of the facet joint. Next, all patients underwent internal fixation with titanium pedicle screw. Afterwards, we removed the spinous process and part of the lamina of the diseased segment, approximately the inferior ½ of the superior lamina, superior ½ of the inferior lamina, and the facet joint was preserved. But for the satisfying decompression, about 2/3 of inferior articular process of the superior vertebral body should be removed. (Figure2). To be next, posterior neural decompression for lumbar spinal stenosis and Lumbar discectomy were accomplished. In the end, we closed the wound with a drainage at the proper location.

Postoperative Management

Postoperatively, all patients received standardized care protocols. On the first postoperative day, patients were permitted to sit on the bed while wearing a rigid brace. Pain management included analgesics and anti-inflammatory medications administered until discharge. The decision to remove drainage tubes was based on a criterion of "drainage volume < 50 ml." Upon meeting this criterion, drainage tubes were removed, and patients were mobilized with the assistance of a rigid lumbosacral brace. Additionally, patients were instructed to wear the brace for a duration of 3-6 months postoperatively to prevent further damage that could compromise the integrity of the well-fixed instrumentation. These measures aimed to support optimal postoperative recovery and long-term spinal health.

Clinical and Radiological Assessment

Clinical outcomes were assessed both preoperatively and postoperatively at 6, 12, and 24 months of follow-up. Pain levels were measured using Visual Analog Scale (VAS) pain scores, while functional disability was evaluated using the Japanese Orthopaedic Association (JOA) and Oswestry Disability Index (ODI). Clinical outcomes were categorized as excellent, good, fair, or poor based on the MacNab¹⁵ classification(Table 1) during the final evaluation. Clinical assessments were conducted by two independent observers to ensure accuracy and reliability.

The fusion status of the facet joints was evaluated using lumbar CT scans obtained at 6 months, 1 year, and 2 years postoperatively. All operated facet joints were included in calculating the fusion rate, assessed consistently by the same physician throughout the follow-up period. Fusion assessment was based on a comprehensive classification system⁸, as outlined in Table 2. Radiographic findings corresponding to different classifications are depicted in Figure 3. This standardized approach ensured thorough evaluation and accurate determination of fusion status over time.

Table 1: MacNab Classification

Outcome	Complications
Excellent	No pain; no restriction of activity
Good	Occasional back or leg pain not interfering with the patient's ability to do his or her normal work, or to enjoy leisure activities
Fair	Improved functional capacity, but handicapped by intermittent pain of sufficient severity to curtail or modify work or leisure activities
Poor	No improvement or insufficient improvement to enable an increase in activities/or further operative intervention required

Table 2: Radiographic Criteria for Fusion Assessment

Fusion Assessment	Radiographic Findings
Grade1	Complete bony continuity covering awhole facet joint (Figure 3A)
Grade2	Partial bony continuity on a facet joint (Figure 3B)
Grade3	Bony continuity was not confirmed with certainty at any portion of a facet joint (Figure 3C)
Grade4	Obvious nonunion of a facet joint (Figure 3D)

Final outcome: Fusion succeed: Grade1 or Grade 2, or both.

Fusion failed: Grade3 or Grade 4.

Furthermore, data regarding the length of the incision, operative time, amount of blood loss, length of hospital stay, perioperative complications, and reoperations were extracted from patient records. Perioperative complications encompassed iatrogenic nerve damage, epidural hematoma, dural tear, vascular injuries, wound infection, poor wound healing, venous thrombosis, and loosening or breakage of the pedicle screw. These parameters were systematically reviewed to assess the safety and efficacy of the surgical procedure.

Data Analysis

Categorical variables were presented as numbers and proportions, while continuous variables were summarized using means and standard deviations. Preoperative and postoperative scores on VAS, JOA, and ODI were compared using paired t-tests. A two-sided p-value of less than 0.05 was considered statistically significant. Statistical analyses were conducted using SPSS statistical software (version 23.0, SPSS, IL).

Patient statistics

This study included a total of 272 facet joints from 136 eligible patients. Among these patients, 74 were female and 62 were male, with a mean age of 55.2 years. All patients had a minimum follow-up period of 2 years. The average values for blood loss, length of incision, operation time, and hospital stay were 257.84 mL, 13.46 cm, 107.25 minutes, and 7.9 days, respectively.

Clinical outcomes

As depicted in Table 3, the Visual Analog Scale (VAS) scores exhibited a significant decrease from 4.77±0.91 preoperatively to 1.55±0.78 at the final follow-up (P < 0.05), indicating substantial improvement in pain levels. Furthermore, the Japanese Orthopaedic Association (JOA) scores showed improvement from 11.08±3.24 before surgery to 25.93±4.68 at the 2-year follow-up (P < 0.05), highlighting enhanced functional outcomes. Additionally, Oswestry Disability Index (ODI) scores decreased from 53.36±7.81 preoperatively to 16.5±5.87 at the final follow-up (P < 0.05), indicating marked improvement in functional disability.

At the 2-year follow-up, 123 patients (90.4%) exhibited excellent or good results, while 10 patients (7.4%) had fair results, and 3 patients (2.2%) had poor results, as demonstrated in Table 4. These findings underscore the favorable clinical outcomes achieved with the thermal ablation technique for facet joint fusion.

Table 3: PreOp, 6 months ,1 year and 2 years outcomes

	PreOp	6 months	1 year	2 years
VAS	4.77±0.91	2.66±0.82	1.85±0.86	1.55±0.78
JOA	11.08±3.24	20.75±4.36	24.68±5.11	25.93±4.68
ODI	53.36±7.81	28.75±6.91	19.13±6.33	16.50±5.87

All changes compared to PreOp are significant (p < 0.05)

Table 4: Clinical results at the 2-years follow-up

Results	Patients
Excellent	82
Good	41
Fair	10
Poor	3

Radiological outcomes

As outlined in Table 5, based on radiographic criteria, the 272 facet joints evaluated exhibited the following classifications: at the 6-month follow-up, 106 were classified as grade 1, 144 as grade 2, 238 as grade 3, and 56 as grade 4; at the 1-year follow-up, 218 were grade 1, 210 were grade 2, 88 were grade 3, and 28 were grade 4; and at the final follow-up, 226 were grade 1, 235 were grade 2, 70 were grade 3, and 13 were grade 4.

Consequently, the fusion rates at the respective follow-up time points were 46.0% at 6 months, 78.7% at 1 year, and 84.7% at the final follow-up. These findings underscore the progressive improvement in fusion rates over time, indicative of successful facet joint fusion outcomes using the thermal ablation technique.

Table 5: Fusion rate among 544 facet joint at 6 months ,1 year and 2 years follow up

Fusion assessment	6-months	1-years	2-years
Grade1	106	218	226
Grade2	144	210	235
Grade3	238	88	70
Grade4	56	28	13
Fusion successful	250	428	461
Fusion failed	294	116	83
Fusion rate	46.0%	78.7%	84.7%

Complications and Reoperation Rates

No cases of venous thrombosis were detected during the study period. Additionally, there were no instances of poor wound healing, but two cases of superficial wound infection were reported. These infections were successfully managed with specific antibiotics. One patient experienced a delayed deep infection, which was resolved through debridement and removal of instrumentation.

Dural tears occurred in two patients; however, there were no instances of cerebrospinal fluid leakage following dural repair, and no sequelae were observed during follow-up. One case of nerve root damage resulted in footdrop, but symptoms gradually improved with rehabilitation treatment.

The overall complication rate was 4.4%, with no occurrences of vascular injuries, epidural hematoma, or technique-related complications. None of the patients required reoperation, indicating favorable postoperative outcomes. Please refer to Table 6 for a summary of complications.

Table 6: Complications

Complication	n
Poor wound healing	8
Superficial wound infection	2
venous thrombosis	4
dural tear	2
iatrogenic nerve damage	0
epidural hematoma	0
loosening or breakage of the pedicle screw	0

In this study, we investigated the clinical outcomes and fusion rates of patients who underwent facet joint fusion using thermal ablation without bone grafting. The pivotal aspect of this surgical approach involved the precise ablation of the capsule surrounding the facet joint using a Surgical electrotome. Through this process, the articular cartilage was completely removed using the electric current and generated heat, a technique termed thermal ablation. Subsequently, with the cartilage removed and the subchondral bone exposed, a conducive environment was created for the growth of bone trabeculae.

This innovative approach offers several potential advantages. Firstly, by eliminating the need for bone grafting, the procedure circumvents the associated donor site morbidity and reduces surgical complexity. Secondly, thermal ablation provides precise and controlled removal of the articular cartilage, allowing for a more uniform fusion bed. Additionally, the preservation of the facet joint anatomy may contribute to better biomechanical stability and reduced risk of adjacent segment degeneration.

Moreover, by leveraging modern surgical techniques and instrumentation, such as the Surgical electrotomy, surgeons can achieve consistent and reproducible results. The use of thermal ablation also minimizes tissue trauma and preserves soft tissue integrity, potentially leading to faster postoperative recovery and improved patient satisfaction.

However, despite these promising aspects, it is essential to acknowledge potential limitations and challenges associated with thermal ablation. Further long-term studies with larger sample sizes are warranted to assess the durability and sustainability of facet joint fusion achieved through thermal ablation. Additionally, comparative studies with traditional fusion techniques are necessary to establish the efficacy and safety of this novel approach.

In conclusion, facet joint fusion via thermal ablation without bone grafting represents a promising alternative in the surgical management of lumbar spinal stenosis. This technique offers potential advantages in terms of surgical simplicity, preservation of anatomical integrity, and reduced morbidity. Further research and clinical experience are needed to validate its long-term effectiveness and safety.

The findings of our study demonstrate significant and sustained clinical improvements in Visual Analog Scale (VAS) scores, Japanese Orthopaedic Association (JOA) scores, and Oswestry Disability Index (ODI) scores throughout all follow-up time points. Notably, excellent or good results were achieved in 90.4% of patients, indicating favorable clinical outcomes. Additionally, the fusion rate of all facet joints at the 2-year follow-up was 84.7%, suggesting successful fusion with the thermal ablation technique. Importantly, no complications directly related to the operative technique were observed, underscoring the safety and efficacy of thermal ablation of the facet joints without bone grafting. Based on our results, thermal ablation represents a promising alternative method for achieving facet joint fusion in patients with lumbar spinal stenosis. These findings suggest that thermal ablation may offer several advantages, including reduced surgical complexity, preservation of anatomical integrity, and favorable clinical outcomes. However, further research and long-term studies are needed to validate these findings and establish the durability and effectiveness of thermal ablation as a fusion method for facet joints.

The fusion rates of other fusion techniques reported in the past studies are summarized in Table 7. There were study showed that PLIF acquired a significantly better fusion rate than PLF, which comes from An et al¹⁶ (91.1% vs 89.4%) and Kuraishi et al¹⁷ (89.5% vs 72.3%) .

There were several meta-analyses^6,7,18,19 which were in surport of the results mentioned above. We consulted other relevant study from Hoy et al²⁰, Fujimori et al²¹, and Ghasemi²². There were some studies represented that TLIF also showed better fuison rate than PLF (Hoy et al 94% vs 88%, Fujimori et al 96% vs 84%, and Ghasemi 92% vs 81%). Nevertheless, Zhang et al²³ and Al et al²⁴ declared that the fusion rate has no significantly differences between TLIF and PLF. On the basis of a meta-analysis by Bevevino²⁵, the fusion rate of MIS-TLIF was 94.7%. The fusion rate of OLIF was 87.2%, reported by Takayoshi Shimizu et al²⁶. Moreover, the fusion rate of the MFF reported by Ren ZN et al¹⁴ was 96.1%.From what has been discussed above, Although our fusion rate is not as high as other fusion technique, thermal ablation is less complicated than other techniques and less invasiveness. From the previous study, the anterior and middle column provides 80% of the weight bearing load of the spinal column^27,28, because our method does not invade the anterior and middle column, so obviously we can preserve the stability of the spine itself as much as possible ,also the procedure is simpler, which not only reduces the operative time and intraoperative blood loss, but also reduces the probability of postoperative complications and lead to better clinical outcomes. As for the comparison with TLIF, our method has no need for unilateral facet joint excision, intervertebral disc removal and intervertebral cage implantation, which can reduce the occurrence of dural tear, nerve damage and the blood loss.

To our knowledge, this is the first study to introduce a way of facet joint fusion without bone graft. Surgical results can be achieved solely through the use of instruments for thermal ablation of small joints, compared to TLIF surgery, this method does not require the removal of articular processes, the handling of intervertebral discs, or the placement of fusion cages, reducing surgical risks such as dural tears, nerve damage, bleeding, etc. Our study has achieved a satisfying result. The fusion rate of all the facet joints at the 2-years follow up was 84.7%. For those nonunion patients, most of them showed excellent results. There was no technique-related complication founded and the revision surgery rate was 0%.

Table 7:The fusion rates of other fusion techniques reported in the past studies

Comparison	Fusion rate	Authors
PLFvsPLIF	significantly better in PLlF	Luo(2017)⁶
PLIFvsPLFvsPLIF+PLF	PLIF:93.0%;PLF:84.5%;PLIF+PLF:93.5%	Liu(2014)⁷
PLFvsPLIF	PLF:89.4%;PLIF:91.1%	An(2016)¹⁶
PLFvsPLIF	PLF:72.3%;PLIF:89.5%	Kuraishi(2016)¹⁷
PLFvsPLIF	PLF:83.4%;PLIF:91.5%	Campbell(2017)¹⁸
PLFvsPLIF	PLF:79.6%;PLIF:92.5%	Liu(2014)¹⁹
PLvsTLIF	PLF:88%;TLIF:94%	Hoy(2017)²⁰
PLFvsTLIF	PLF:84%;TLIF:96%	Fujimori(2015)²¹
PLFvsTLIF	PLF:81%;TLIF:92%	Ghasemi(2016)²²
PLFvsTLIF	no significant difference	Zhang(2016)²³
PLFvsPLIFvsTLIF	PLF:90%;PLIF:92%;TLIF:94%	AI(2015)²⁴
MISTLIF	94.7%	Bevevino(2014)²⁵
OLIF	87.2%	Takayoshi Shimizu(2021)²⁶
MFF	96.1%	Ren ZN(2020)¹⁴

Limitation

The patients involved were inadequate
This fusion method is applicable to minority
prospective randomized controlled trials (RCTs) are needed to further evaluation
Insufficient follow-up time

This study provides compelling evidence that facet joint fusion achieved through thermal ablation, without the need for bone grafting, can preserve spinal anatomy and stability and yield satisfactory clinical outcomes and fusion rates, which offers several advantages, including reduced surgical complexity, shorter operative times, and decreased risk of donor site morbidity.

Overall, the results of this study support the feasibility and efficacy of facet joint fusion by thermal ablation as a viable treatment option for patients with single-level lumbar spinal stenosis. Further research and long-term studies are warranted to validate these findings and establish thermal ablation as a standard of care in the surgical management of lumbar spinal stenosis.

Human rights:

The authors declare that the work described was performed in accordance with the Declaration of Helsinki of the World Medical Association revised in 2013 for experiments involving humans.

Ethical approval:

This study has been approved by the Ethics Committee of Shengjing Hospital Affiliated to China Medical University, and promised to safeguard the rights and interests of patients, ethics number 2024PS1245K.

Informed consent and patient details:

The authors declare that this report does not contain any personal information that could lead to the identification of the patients

Funding:

This work did not receive any grant from funding agencies in the public, commercial, or not-for-profit sectors.

Data availability statement:

The authors confirm that the data supporting the findings of this study are available within the article.

Conflicts of Interest:

The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Conflicts of Interest:

Author contributions:

Puzhou Lei, Xinyue Wang contributed equally to this work. Puzhou Lei, Xinyue Wang contributed to the conception of the study and acquired the data and performed data analysis. Puzhou Lei contributed significantly to manuscript preparation. Shuai Huang, Linghanqing Wang, Sida Chen, Siyu Zhang, Cheng Li, Lei Li revised the work critically for important intellectual content. All authors read and approved the final manuscript.

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No competing interests reported.

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Facet joint fusion by thermal ablation for single-level lumbar spinal stenosis

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