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MINIMALLY INVASIVE LUMBAR ARTHRODESIS AND PERCUTANEOUS PEDICLE SCREWS: A SYSTEMATIC REVIEW

ARTRODESE LOMBAR MINIMAMENTE INVASIVA E PARAFUSOS PEDICULARES PERCUTÂNEOS: REVISÃO SISTEMÁTICA

ARTRODESIS LUMBAR MÍNIMAMENTE INVASIVA Y TORNILLOS PEDICULARES PERCUTÁNEOS: REVISIÓN SISTEMÁTICA

ABSTRACT

A systematic review of the literature was performed in order to organize, evaluate, and select evidences available about the safety and efficacy of minimally invasive percutaneous arthrodesis with percutaneous pedicle screws in the treatment of patients with degenerative disc disease (and other spinal pathologies) as compared to conventional arthrodesis. PubMed, EMBASE and Cochrane Library databases were consulted to locate clinical trials and case reports/case series published in English between 2014 and 2019. After selection according to the inclusion/exclusion criteria, 21 of the 197 articles identified were chosen for a complete reading and used for the present review. Although the level of evidence of most of the studies included made the demonstration of efficacy and superiority among the surgical techniques reviewed difficult, the findings related to the minimally invasive procedure indicate a safe and reliable approach for the treatment of lumbar diseases. Level of evidence II; Systematic review of literature.

Arthrodesis; Case Reports; Clinical Trial; Pedicle Screws; Spine; Spinal Fusion

RESUMO

A revisão sistemática da literatura foi realizada com o objetivo de organizar, avaliar e selecionar evidências a respeito da segurança e eficácia da artrodese percutânea minimamente invasiva com parafusos pediculares percutâneos no tratamento de pacientes com doença degenerativa de disco (e outras patologias da coluna), em comparação com a artrodese convencional. Foram consultadas as bases de dados PubMed, EMBASE e Biblioteca Cochrane para localizar ensaios clínicos e relatos/séries de casos publicados em inglês entre 2014 e 2019. Dentre 197 estudos identificados, depois de seleção usando critérios de inclusão/exclusão, 21 artigos foram escolhidos para leitura na íntegra e usados na presente revisão. Apesar do nível de evidência da maioria dos estudos incluídos dificultar a demonstração de eficácia e superioridade entre as técnicas cirúrgicas revisadas, os achados referentes ao procedimento minimamente invasivo apontam para uma abordagem segura e confiável para o tratamento de doenças lombares. Nível de evidência II; Revisão sistemática da literatura.

Artrodese; Relatos de Casos; Ensaio Clínico; Parafusos Pediculares; Coluna Vertebral; Fusão Vertebral

RESUMEN

La revisión sistemática de la literatura fue realizada con el objetivo de organizar, evaluar y seleccionar evidencias al respecto de la seguridad y eficacia de la artrodesis percutánea mínimamente invasiva con tornillos pediculares en el tratamiento de pacientes con enfermedad degenerativa de disco (y otras patologías de la columna) en comparación con la artrodesis convencional. Fueron consultadas las bases de datos PubMed, EMBASE y Biblioteca Cochrane para localizar ensayos clínicos y relatos/series de casos publicados en inglés entre 2014 y 2019. Entre 197 estudios identificados, después de selección usando criterios de inclusión/exclusión, fueron escogidos 21 artículos para lectura integral y usados en la presente revisión. A pesar de que el nivel de evidencia de la mayoría de los estudios incluidos dificulte la demostración de eficacia y superioridad entre las técnicas quirúrgicas revisadas, los hallazgos referentes al procedimiento mínimamente invasivo apuntan hacia un abordaje seguro y confiable para el tratamiento de enfermedades lumbares. Nivel de evidencia II; Revisión sistemática de la literatura.

Artrodesis; Informes de Casos; Ensayo Clínico; Tornillos Pediculares; Columna Vertebral; Fusión Vertebral

INTRODUCTION

Arthrodesis (or fusion) is a commonly used technique for the treatment of degenerative lumbar diseases11. Bono CM, Lee CK. Critical analysis of trends in fusion for degenerative disc disease over the past 20 years: influence of technique on fusion rate and clinical outcome. Spine (Phila Pa 1976). 2004;29(4):455–63. and its use has grown substantially in recent decades,44. Yavin D, Casha S, Wiebe S, Feasby TE, Clark C, Isaacs A, et al. Lumbar fusion for degenerative disease: a systematic review and meta-analysis. Clin Neurosurg. 2017;80(5):701–15. however, the conventional approaches and instrumentations used in open procedures demand extensive tissue dissection, which is associated with traumas, blood loss, reoperation rates, and substantial costs.55. Thomsen K, Christensen FB, Eiskjær SP, Hansen ES, Fruensgaard S, Bünger CE. The effect of pedicle screw instrumentation on functional outcome and fusion rates in posterolateral lumbar spinal fusion: A prospective, randomized clinical study. Spine (Phila Pa 1976). 1997;22(24):2813–22. With these issues in mind, minimally invasive fusion is proposed in pathological spinal conditions,88. Foley KT, Gupta SK. Percutaneous pedicle screw fixation of the lumbar spine: preliminary clinical results. J Neurosurg. 2002;97(1 Suppl):7–12. significantly reducing blood loss and tissue damage, and making the patient’s faster recovery and better rehabilitation possible.99. Kim DY, Lee SH, Sang KC, Lee HY. Comparison of multifidus muscle atrophy and trunk extension muscle strength: Percutaneous versus open pedicle screw fixation. Spine (Phila Pa 1976). 2005;30(1):123–9. In minimally invasive lumbar arthrodesis surgeries, the placement of percutaneous pedicle screws provides fusion without extensive incisions, which reduces the probability of complications.1313. Dangelmajer S, Zadnik PL, Rodriguez ST, Gokaslan ZL, Sciubba DM. Minimally invasive spine surgery for adult degenerative lumbar scoliosis. Neurosurg Focus. 2014;36(5):E7. The objective of this systematic review was to investigate evidence related to the safety and efficacy of minimally invasive percutaneous arthrodesis with percutaneous pedicle screws in the treatment of patients with degenerative disc disease (and other pathological spinal conditions) as compared to conventional open arthrodesis.

METHODS

This systematic review was conducted in accordance with the PRISMA statement1414. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JPA, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009;339:b2700. , 1515. Moher D, Liberati A, Tetzlaff J, Altman DG, Altman D, Antes G, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement (Chinese edition).Chin J Integr Med. 2009;339:b2535. and was registered in the PROSPERO database as number CRD42019133252. The inclusion criteria were articles related to patients with degenerative disc disease and arthrosis or facet joint degeneration, degenerative scoliosis/adult scoliosis, spinal instability, a history of previous lumbar spine surgery, spinal canal stenosis, spinal fractures of traumatic, neoplastic, osteoporotic, infectious, and/or rheumatological origins treated with minimally invasive percutaneous arthrodesis with percutaneous pedicle screws or conventional open arthrodesis, written in English, including clinical trials and case series/reports. Incomplete texts were excluded. The PubMed, Cochrane Library, and EMBASE databases were used to locate articles published from 2014 to April 2, 2019. The title and abstract of each article were analyzed to eliminate duplicate articles and the full text of potentially relevant articles was retrieved for analysis. Subsequently, the texts were examined by two independent reviewers, who applied the Oxford Centre for Evidence-Based Medicine (OCEBM) scale1616. Durieux N, Pasleau F, Howick J. The Oxford 2011 levels of evidence. Oxford Centre for Evidence-based Medicine. 2011. to all of the articles in order to classify them according to level of evidence. The following items (when available) were collected from each article: author(s); year of publication; study design; number of participants; mean age, sex, and diagnosis of the participants; intervention; control group; instrumentation; graft/implant used; surgical time (minutes); blood loss (ml); complications/adverse events; reoperation/revision; duration of follow-up (months); outcome measurements; Visual Analog Scale or VAS (pain); Oswestry Disability Index or ODI; and conclusions.

RESULTS

The initial search of the PubMed, Cochrane Library, and EMBASE data bases using “intervertebral disc degeneration”, “arthropathies”, “spondylolysis”, “scoliosis”, “spinal stenosis”; “spinal fractures”, “arthrodesis”, “spinal fusion”, “pedicular screws”, and “minimally invasive surgical procedures”, adapting the keywords to each of the databases and including synonyms, with filters for clinical trials or case reports/series, written in English, published between 2014 and 2019, identified 197 articles. After the elimination of duplicates, 162 articles remained. Two authors reviewed the titles and abstracts of the remaining works, selecting them according to the inclusion criteria. Only clinical trials and case reports/series related to minimally invasive percutaneous arthrodesis with percutaneous pedicle screws for the treatment of patients with degenerative disc disease (and other pathological spinal conditions) were included, resulting in 40 articles. Publications in languages other than English were also excluded in this step. The final step was to fully review each of the 40 eligible articles, comprising 2 prospective randomized controlled studies, 1 prospective non-randomized controlled study, and 18 case reports/series, resulting in a total of 21 articles for inclusion in the systematic review. ( Figure 1 )

Figure 1
Schedule for articles published in databases.

A total of 230 participants/cases (129 who were submitted to minimally invasive procedures and101 to conventional open procedures) were included in this systematic review. Most of the results came from patients/participants diagnosed with stenosis (54.3%) or spondylolisthesis (14.8%). The results were expressed as mean values ± standard deviations. The data collected from the 3 clinical trials and the 18 case reports/series are summarized in Table 1 .

Table 1
Summarization of the 21 articles selected for inclusion in the systematic review.

Mean participant age: The 3 clinical trials had similar mean participant ages, as shown in Table 1 . Considering all the selected case reports/series together, the mean age of the 30 participants was 52.2 ± 22.2 years.

Diagnosis: The most reported diagnosis was stenosis, found in the 3 clinical trials 1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. , 2424. Kim HJ, Lee SH, Chang BS, Lee CK, Lim TO, Hoo LP, et al. Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test. Spine (Phila Pa 1976). 2015;40(2):87–94. , 2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. and 3 case reports.1717. Chachan S, Bae J, Lee S, Suk J, Shin S. Microscopic anterior neural decompression combined with oblique lumbar interbody fusion—a technical note. World Neurosurg. 2019;121:37–43. , 2020. Coe J, Zucherman J, Kucharzyk D, Poelstra K, Miller L, Kunwar S. Multiexpandable cage for minimally invasive posterior lumbar interbody fusion. Med Devices (Auckl). 2016;9:341–7. , 3737. Chin KR, Seale J, Cumming V. Mini-open or percutaneous bilateral lumbar transfacet pedicle screw fixation: a technical note. J Spinal Disord Tech. 2015;28(2):61–5. A total of 62 participants with stenosis were described in minimally invasive procedures and 63 in open procedures. The second most reported diagnosis was spondylolisthesis, present in 1 clinical trial2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. and in 4 case reports.1717. Chachan S, Bae J, Lee S, Suk J, Shin S. Microscopic anterior neural decompression combined with oblique lumbar interbody fusion—a technical note. World Neurosurg. 2019;121:37–43. , 2020. Coe J, Zucherman J, Kucharzyk D, Poelstra K, Miller L, Kunwar S. Multiexpandable cage for minimally invasive posterior lumbar interbody fusion. Med Devices (Auckl). 2016;9:341–7. , 2727. Tender G. Caudal vertebral body fractures following lateral interbody fusion in nonosteoporotic patients. Ochsner J. 2014;14(1):123–30. , 3434. Phan K, Mobbs RJ. Sacrum fracture following L5-S1 stand-alone interbody fusion for isthmic spondylolisthesis. J Clin Neurosci. 2015;22(11):1837–9. A total of 19 participants with this pathology were described in minimally invasive procedures, while 15 were described in open procedures. Other diagnoses are described in Table 1 .

Intervention: Five different fusion procedures were reviewed: 215 cases of lumbar fusion, 1 case of thoracic fusion, 9 cases of thoracolumbar fusion, 2 cases of thoracolumbosacral fusion, and 3 cases of lumbosacral fusion. Among them, 129 were performed by minimally invasive approach, while open procedures were applied in 101 cases. Lumbar fusion was the main technique used for the treatment of spondylolisthesis1717. Chachan S, Bae J, Lee S, Suk J, Shin S. Microscopic anterior neural decompression combined with oblique lumbar interbody fusion—a technical note. World Neurosurg. 2019;121:37–43. , 2020. Coe J, Zucherman J, Kucharzyk D, Poelstra K, Miller L, Kunwar S. Multiexpandable cage for minimally invasive posterior lumbar interbody fusion. Med Devices (Auckl). 2016;9:341–7. , 2727. Tender G. Caudal vertebral body fractures following lateral interbody fusion in nonosteoporotic patients. Ochsner J. 2014;14(1):123–30. , 2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. , 3434. Phan K, Mobbs RJ. Sacrum fracture following L5-S1 stand-alone interbody fusion for isthmic spondylolisthesis. J Clin Neurosci. 2015;22(11):1837–9. and stenosis.1717. Chachan S, Bae J, Lee S, Suk J, Shin S. Microscopic anterior neural decompression combined with oblique lumbar interbody fusion—a technical note. World Neurosurg. 2019;121:37–43. , 1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. , 2020. Coe J, Zucherman J, Kucharzyk D, Poelstra K, Miller L, Kunwar S. Multiexpandable cage for minimally invasive posterior lumbar interbody fusion. Med Devices (Auckl). 2016;9:341–7. , 2424. Kim HJ, Lee SH, Chang BS, Lee CK, Lim TO, Hoo LP, et al. Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test. Spine (Phila Pa 1976). 2015;40(2):87–94. , 2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. , 3737. Chin KR, Seale J, Cumming V. Mini-open or percutaneous bilateral lumbar transfacet pedicle screw fixation: a technical note. J Spinal Disord Tech. 2015;28(2):61–5.

Control: Only the three clinical trials had control groups. Kim et al. (2018)1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. had a conventional open posterior lumbar interbody fusion group (Cop-PLIF) as the control for Robot-PLIF. Kim et al. (2015),2424. Kim HJ, Lee SH, Chang BS, Lee CK, Lim TO, Hoo LP, et al. Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test. Spine (Phila Pa 1976). 2015;40(2):87–94. also with an interventional group that underwent Rom-PLIF, had a Cop-PLIF group for comparison. In turn, Wang et al.,2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. who had minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) as the intervention, described open transforaminal lumbar interbody fusion (TLIF) as the control procedure.

Instrumentation: The use of pedicle screws was reported in all the studies included. It is important to mention that 11 studies1717. Chachan S, Bae J, Lee S, Suk J, Shin S. Microscopic anterior neural decompression combined with oblique lumbar interbody fusion—a technical note. World Neurosurg. 2019;121:37–43. , 1919. Anand N, Kong C, Fessler RG. A staged protocol for circumferential minimally invasive surgical correction of adult spinal deformity. Neurosurgery. 2017;81(5):733–9. , 2121. Maruo K, Tachibana T, Inoue S, Arizumi F, Yoshiya S. Hemothorax caused by the trocar tip of the rod inserter after minimally invasive transforaminal lumbar interbody fusion: case report. J Neurosurg Spine. 2016;24(3):394–7. , 2222. Wang Q, Xu Y, Chen R, Dong J, Liu B, Rong L. A novel indication for a method in the treatment of lumbar tuberculosis through minimally invasive extreme lateral interbody fusion (XLIF) in combination with percutaneous pedicle screws fixation in an elderly patient: A case report. Medicine (Baltimore). 2016;95(48):e5303. , 2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. , 3030. Fomekong E, Pierrard J, Danse E, Tombal B, Raftopoulos C. An unusual case of ureteral perforation in minimally invasive pedicle screw instrumentation: case report and review of the literature. World Neurosurg. 2018;111:28–35. refer to instrumentation with percutaneous pedicle screws and 121818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. , 2020. Coe J, Zucherman J, Kucharzyk D, Poelstra K, Miller L, Kunwar S. Multiexpandable cage for minimally invasive posterior lumbar interbody fusion. Med Devices (Auckl). 2016;9:341–7. , 2323. Dailey S, Crawford A, Asghar F. Implant failure following posterior spinal fusion-caudal migration of a fractured rod: case report. Spine Deform. 2015;3(4):380–5. , 2424. Kim HJ, Lee SH, Chang BS, Lee CK, Lim TO, Hoo LP, et al. Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test. Spine (Phila Pa 1976). 2015;40(2):87–94. , 2626. Brodano GB, Martikos K, Vommaro F, Greggi T, Boriani S. Less invasive surgery in idiopathic scoliosis: a case report. Eur Rev Med Pharmacol Sci. 2014;18(1 Suppl):24–8. refer to pedicle screws. Some of them specify other types of instrumentation used in conjunction with the screws: cage (6 studies),2020. Coe J, Zucherman J, Kucharzyk D, Poelstra K, Miller L, Kunwar S. Multiexpandable cage for minimally invasive posterior lumbar interbody fusion. Med Devices (Auckl). 2016;9:341–7. , 2121. Maruo K, Tachibana T, Inoue S, Arizumi F, Yoshiya S. Hemothorax caused by the trocar tip of the rod inserter after minimally invasive transforaminal lumbar interbody fusion: case report. J Neurosurg Spine. 2016;24(3):394–7. , 2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. , 3535. Wakita H, Shiga Y, Ohtori S, Kubota G, Inage K, Sainoh T, et al. Less invasive corrective surgery using oblique lateral interbody fusion (OLIF) including L5-S1 fusion for severe lumbar kyphoscoliosis due to L4 compression fracture in a patient with Parkinson’s disease: a case report. BMC Res Notes. 2015;8:126. rod (1 study),3232. Suratwala SJ, Cronin M, Kondra K, Leone V. Acute renal infarction after lateral lumbar interbody spinal fusion for kyphoscoliosis. Spine Deform. 2016;4(5):385–9. and percutaneous s2AI screws (1 study).3333. Funao H, Kebaish KM, Isogai N, Koyanagi T, Matsumoto M, Ishii K. Utilization of a technique of percutaneous S2 alar-iliac fixation in immunocompromised patients with spondylodiscitis. World Neurosurg. 2017;97:757.e11-757.e18. Tender et al.2727. Tender G. Caudal vertebral body fractures following lateral interbody fusion in nonosteoporotic patients. Ochsner J. 2014;14(1):123–30. reported the use of cage and plate in one of their cases and the use of plate only in another of the cases reported, however, these instruments were used without pedicle screws (which are mentioned only during the revision surgery).

Graft/Implant: Fifteen studies report the use of grafts or implants in the surgical procedures. Among these, only 2 describe the use of implants.2323. Dailey S, Crawford A, Asghar F. Implant failure following posterior spinal fusion-caudal migration of a fractured rod: case report. Spine Deform. 2015;3(4):380–5. , 3434. Phan K, Mobbs RJ. Sacrum fracture following L5-S1 stand-alone interbody fusion for isthmic spondylolisthesis. J Clin Neurosci. 2015;22(11):1837–9. The other 13 studies report the use of different types of grafts, as shown in Table 1 .

Surgical time: Nine studies1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. , 2424. Kim HJ, Lee SH, Chang BS, Lee CK, Lim TO, Hoo LP, et al. Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test. Spine (Phila Pa 1976). 2015;40(2):87–94. , 2626. Brodano GB, Martikos K, Vommaro F, Greggi T, Boriani S. Less invasive surgery in idiopathic scoliosis: a case report. Eur Rev Med Pharmacol Sci. 2014;18(1 Suppl):24–8. reported surgical time. Only 2 clinical trials provided this information. Kim et al.,1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. reported a mean surgical time of 220.1 ± 55.9 minutes for the Robot-PLIF group and of 189.8 ± 45.1 minutes for the Freehand-PLIF group. In turn, Kim et al.,2424. Kim HJ, Lee SH, Chang BS, Lee CK, Lim TO, Hoo LP, et al. Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test. Spine (Phila Pa 1976). 2015;40(2):87–94. reported 217.7 ± 33.9 minutes for the Rom-PLIF group, while the mean time for the Cop-PLIF group was 195 ± 46.9 minutes. The case reports/series had a mean surgical time of 241.6 ± 94.5 minutes for the minimally invasive procedures. One of the studies selected2727. Tender G. Caudal vertebral body fractures following lateral interbody fusion in nonosteoporotic patients. Ochsner J. 2014;14(1):123–30. reported mean surgical time for cage and plate procedures, but not for cases related to fusion with pedicle screws.

Blood loss: Eleven studies reported blood loss during the surgical procedures, only one of which was a clinical trial.2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. In this study the authors described mean blood loss of the minimally invasive procedures (274 ± 99 ml) and of the open procedures (645 ± 163 ml) (p < 0.01). Ntourantonis et al.,2929. Ntourantonis D, Tsekouras V, Korovessis P. Delayed fatal lumbar artery bleeding following less invasive posterolateral decompression and fusion. Spine (Phila Pa 1976). 2018;43(16):e976-9. reported blood loss during the surgical procedure in their case report, but did not provide volume information. The mean blood loss for the 9 case reports/series that did report this information was 330.5 ± 255.0 ml.

Complications/adverse events: Among the 21 studies selected, there was an overall complications rate of 57.1% (12 studies – 2 clinical trials and 10 case reports/series), as shown in Table 1 . Four studies1717. Chachan S, Bae J, Lee S, Suk J, Shin S. Microscopic anterior neural decompression combined with oblique lumbar interbody fusion—a technical note. World Neurosurg. 2019;121:37–43. , 2020. Coe J, Zucherman J, Kucharzyk D, Poelstra K, Miller L, Kunwar S. Multiexpandable cage for minimally invasive posterior lumbar interbody fusion. Med Devices (Auckl). 2016;9:341–7. , 2222. Wang Q, Xu Y, Chen R, Dong J, Liu B, Rong L. A novel indication for a method in the treatment of lumbar tuberculosis through minimally invasive extreme lateral interbody fusion (XLIF) in combination with percutaneous pedicle screws fixation in an elderly patient: A case report. Medicine (Baltimore). 2016;95(48):e5303. , 3636. Staub BN, Holman PJ. Lateral retroperitoneal transpsoas interbody fusion in a patient with achondroplastic dwarfism. J Neurosurg Spine. 2015;22(2):162–5. reported the absence of complications, while five studies2424. Kim HJ, Lee SH, Chang BS, Lee CK, Lim TO, Hoo LP, et al. Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test. Spine (Phila Pa 1976). 2015;40(2):87–94. , 2626. Brodano GB, Martikos K, Vommaro F, Greggi T, Boriani S. Less invasive surgery in idiopathic scoliosis: a case report. Eur Rev Med Pharmacol Sci. 2014;18(1 Suppl):24–8. , 3333. Funao H, Kebaish KM, Isogai N, Koyanagi T, Matsumoto M, Ishii K. Utilization of a technique of percutaneous S2 alar-iliac fixation in immunocompromised patients with spondylodiscitis. World Neurosurg. 2017;97:757.e11-757.e18. , 3737. Chin KR, Seale J, Cumming V. Mini-open or percutaneous bilateral lumbar transfacet pedicle screw fixation: a technical note. J Spinal Disord Tech. 2015;28(2):61–5. , 3838. Sarwahi V, Horn J, Kulkarni P, Wollowick A, Lo Y, Gambassi M, et al. Minimally invasive surgery in patients with adolescent idiopathic scoliosis. Clin Spine Surg. 2016;29(8):331–40. did not report any information about complications or adverse events.

Reoperation or revision: Five studies1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. , 2424. Kim HJ, Lee SH, Chang BS, Lee CK, Lim TO, Hoo LP, et al. Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test. Spine (Phila Pa 1976). 2015;40(2):87–94. , 2727. Tender G. Caudal vertebral body fractures following lateral interbody fusion in nonosteoporotic patients. Ochsner J. 2014;14(1):123–30. , 3131. Agarwal N, Choi PA, Sekula RF. Minimally invasive spine surgery for unstable thoracolumbar burst fractures: a case series. Surg J (NY). 2016;2(4):e131-8. , 3434. Phan K, Mobbs RJ. Sacrum fracture following L5-S1 stand-alone interbody fusion for isthmic spondylolisthesis. J Clin Neurosci. 2015;22(11):1837–9. reported the need for reoperation or revision of the surgical procedure, although only one of these2727. Tender G. Caudal vertebral body fractures following lateral interbody fusion in nonosteoporotic patients. Ochsner J. 2014;14(1):123–30. described the procedure. Tender et al., reported 2 cases of patients with degenerative spondylolisthesis, who had undergone lateral lumbar fusion with cage and/or plate. Due to complications related to the surgical procedures, the patients were submitted to a second procedure: the placement of pedicle screws in L4-L5 and S1 and facet joint graft (case 1) and bilateral foraminotomy of L3-L4 followed by instrumented posterolateral fusion of L3-L4 (case 2). Wang et al.,2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. reported the absence of reoperation or revision surgery.

Outcome measurement: Of the 21 studies, only the 3 clinical trials published outcome measurements. Kim et al.,1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. in a study conducted to compare the robot-assisted posterior fusion surgical technique (Robot-PLIF) with conventional posterior fusion (Freehand-PLIF) in patients with degenerative spinal disease through clinical outcomes, used the Visual Analog Scale (or VAS), the Oswestry Disability Index (or ODI), and the SF-36 questionnaire, in addition to radiological evaluation of fusion status (by computed tomography) and flexion/extension and disc degeneration by X-ray, to measure outcomes. Kim et al.,2424. Kim HJ, Lee SH, Chang BS, Lee CK, Lim TO, Hoo LP, et al. Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test. Spine (Phila Pa 1976). 2015;40(2):87–94. reported using cumulative sum control analysis for quality control monitoring of the accuracy of pedicular screw insertion and computed tomography of the accuracy of screw insertion for quality control monitoring of robot-assisted fixation.

Wang et al.,2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. whose study aimed to evaluate the safety and efficacy of minimally invasive transforaminal lumbar interbody fusion (TLIF) as an alternative technique for overweight or obese patients, used changes in surgical time, blood loss, time of exposure to X-rays, and perioperative complications to measure outcomes. Several of the remaining studies reported scores obtained from the VAS and ODI, however, because they are case reports, the scores are not described as outcome measurements.

Visual Analog Scale (VAS) and Oswestry Disability Index (ODI): Of the 21 studies selected, 6 had VAS information (2 clinical trials1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. , 2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. and 4 case reports1717. Chachan S, Bae J, Lee S, Suk J, Shin S. Microscopic anterior neural decompression combined with oblique lumbar interbody fusion—a technical note. World Neurosurg. 2019;121:37–43. , 2222. Wang Q, Xu Y, Chen R, Dong J, Liu B, Rong L. A novel indication for a method in the treatment of lumbar tuberculosis through minimally invasive extreme lateral interbody fusion (XLIF) in combination with percutaneous pedicle screws fixation in an elderly patient: A case report. Medicine (Baltimore). 2016;95(48):e5303. , 2727. Tender G. Caudal vertebral body fractures following lateral interbody fusion in nonosteoporotic patients. Ochsner J. 2014;14(1):123–30. , 3030. Fomekong E, Pierrard J, Danse E, Tombal B, Raftopoulos C. An unusual case of ureteral perforation in minimally invasive pedicle screw instrumentation: case report and review of the literature. World Neurosurg. 2018;111:28–35. ) and 9 (2 clinical trials 1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. , 2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. and 7 case reports1717. Chachan S, Bae J, Lee S, Suk J, Shin S. Microscopic anterior neural decompression combined with oblique lumbar interbody fusion—a technical note. World Neurosurg. 2019;121:37–43. , 2020. Coe J, Zucherman J, Kucharzyk D, Poelstra K, Miller L, Kunwar S. Multiexpandable cage for minimally invasive posterior lumbar interbody fusion. Med Devices (Auckl). 2016;9:341–7. , 2222. Wang Q, Xu Y, Chen R, Dong J, Liu B, Rong L. A novel indication for a method in the treatment of lumbar tuberculosis through minimally invasive extreme lateral interbody fusion (XLIF) in combination with percutaneous pedicle screws fixation in an elderly patient: A case report. Medicine (Baltimore). 2016;95(48):e5303. , 2727. Tender G. Caudal vertebral body fractures following lateral interbody fusion in nonosteoporotic patients. Ochsner J. 2014;14(1):123–30. , 3030. Fomekong E, Pierrard J, Danse E, Tombal B, Raftopoulos C. An unusual case of ureteral perforation in minimally invasive pedicle screw instrumentation: case report and review of the literature. World Neurosurg. 2018;111:28–35. , 3434. Phan K, Mobbs RJ. Sacrum fracture following L5-S1 stand-alone interbody fusion for isthmic spondylolisthesis. J Clin Neurosci. 2015;22(11):1837–9. , 3636. Staub BN, Holman PJ. Lateral retroperitoneal transpsoas interbody fusion in a patient with achondroplastic dwarfism. J Neurosurg Spine. 2015;22(2):162–5. ) had ODI information. Both clinical trials reported a mean value for the participants. Kim et al.,1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. evaluated the VAS for back and leg pain in Robot-PLIF and Freehand-PLIF groups during the pre- and postoperative periods and observed no significant differences between the groups in either period. Wang et al.,2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. used the VAS to assess back pain in the minimally invasive and open procedure groups. No statistical difference between the groups was observed. Intergroup analyses were not shown. As for the case reports/series, none of them reported statistical analysis, although a decrease in scores was observed between the pre- and postoperative periods. As regards the ODI in the clinical trials, Kim et al.,1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. evaluated the Robot-PLIF and Freehand-PLIF group scores during pre- and postoperative periods without significant differences between the groups in either period. Wang et al.,2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. assessed the ODI in minimally invasive and open procedure groups. Once again, no statistically significant differences were observed between the groups and no intragroup analysis was shown. None of the case reports/series demonstrated statistical analysis, although a decrease in the scores had been observed between the pre- and postoperative periods.

Follow-up: The mean duration of follow-up, considering 18 studies ( 3 studies2424. Kim HJ, Lee SH, Chang BS, Lee CK, Lim TO, Hoo LP, et al. Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test. Spine (Phila Pa 1976). 2015;40(2):87–94. , 3333. Funao H, Kebaish KM, Isogai N, Koyanagi T, Matsumoto M, Ishii K. Utilization of a technique of percutaneous S2 alar-iliac fixation in immunocompromised patients with spondylodiscitis. World Neurosurg. 2017;97:757.e11-757.e18. , 3838. Sarwahi V, Horn J, Kulkarni P, Wollowick A, Lo Y, Gambassi M, et al. Minimally invasive surgery in patients with adolescent idiopathic scoliosis. Clin Spine Surg. 2016;29(8):331–40. did not report this information) was 10.1 ± 9.3 months. In the clinical trials the mean duration was 24.1 ± 17.0 months.1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. , 2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. In the cases reports/series this duration was 8.6 ± 7.4 months. Tender et al.,2727. Tender G. Caudal vertebral body fractures following lateral interbody fusion in nonosteoporotic patients. Ochsner J. 2014;14(1):123–30. did not report the exact number of months of follow-up (“> 18 months”) in one of their 2 cases.

Main conclusions: Table 2 summarizes the main conclusions of the studies included in the systematic review, according to the respective authors. Regarding their clinical trials, Kim et al. (2018)1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. and Kim et al.,2424. Kim HJ, Lee SH, Chang BS, Lee CK, Lim TO, Hoo LP, et al. Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test. Spine (Phila Pa 1976). 2015;40(2):87–94. reported that minimally invasive techniques can be beneficial to patients. Wang et al.,2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. concluded that minimally invasive fusion is safe and reliable. The case reports/series presented quite specific and very diversified conclusions, making it impossible to group them.

Table 2
Main conclusions of the 21 selected studies.

DISCUSSION

The main objective of this systematic review was to gather evidence related to the safety and efficacy of minimally invasive arthrodesis/fusion with percutaneous pedicle screws in the treatment of degenerative disc disease (and other pathological spinal conditions) when compared to conventional arthrodesis. A considerable number of studies related to this intervention were identified in the literature (21), although few of the studies reviewed dealt with randomized and controlled clinical trials (2) based on rigorously planned experimental design and, consequently, with more reliable results. Most of the studies included in this review (86%) were case reports and series, studies that present a low level of scientific evidence and are biased by their methodologies. Therefore, the main limitations of the present study are the lack of clinical trials and the small number of articles included with moderate or high levels of evidence.

The conclusions and parameters such as age and follow-up time, for example, are quite different among the case reports, making comparisons and assertive conclusions about the safety and efficacy of the minimally invasive techniques difficult. Among the 18 case reports/series presented in this systematic review, four2626. Brodano GB, Martikos K, Vommaro F, Greggi T, Boriani S. Less invasive surgery in idiopathic scoliosis: a case report. Eur Rev Med Pharmacol Sci. 2014;18(1 Suppl):24–8. , 3333. Funao H, Kebaish KM, Isogai N, Koyanagi T, Matsumoto M, Ishii K. Utilization of a technique of percutaneous S2 alar-iliac fixation in immunocompromised patients with spondylodiscitis. World Neurosurg. 2017;97:757.e11-757.e18. , 3737. Chin KR, Seale J, Cumming V. Mini-open or percutaneous bilateral lumbar transfacet pedicle screw fixation: a technical note. J Spinal Disord Tech. 2015;28(2):61–5. , 3838. Sarwahi V, Horn J, Kulkarni P, Wollowick A, Lo Y, Gambassi M, et al. Minimally invasive surgery in patients with adolescent idiopathic scoliosis. Clin Spine Surg. 2016;29(8):331–40. offered no information about complications or adverse events and only three1717. Chachan S, Bae J, Lee S, Suk J, Shin S. Microscopic anterior neural decompression combined with oblique lumbar interbody fusion—a technical note. World Neurosurg. 2019;121:37–43. , 2020. Coe J, Zucherman J, Kucharzyk D, Poelstra K, Miller L, Kunwar S. Multiexpandable cage for minimally invasive posterior lumbar interbody fusion. Med Devices (Auckl). 2016;9:341–7. , 3636. Staub BN, Holman PJ. Lateral retroperitoneal transpsoas interbody fusion in a patient with achondroplastic dwarfism. J Neurosurg Spine. 2015;22(2):162–5. reported the absence of these situations. All these factors taken together allow only inferences about the safety and efficacy of the technique and of the instrumentation.

Clinical trials conducted to evaluate minimally invasive techniques suggest that these may be beneficial to patients, but the results presented were not significantly different from those obtained from open procedures or required longer follow-up periods, making it difficult to prove the superiority of one procedure over the other.

Despite the difficulty in demonstrating superiority, the findings regarding minimally invasive techniques indicate a safe and reliable procedure and attribute the inconclusive results to limitations related to study design, follow-up time, and number of participants. Of the three clinical trials selected, only two presented an experimental design that included a control group and a randomization technique.1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. , 2424. Kim HJ, Lee SH, Chang BS, Lee CK, Lim TO, Hoo LP, et al. Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test. Spine (Phila Pa 1976). 2015;40(2):87–94. The study by Kim et al.,1818. Kim HJ, Kang KT, Chun HJ, Hwang JS, Chang BS, Lee CK, et al. Comparative study of 1-year clinical and radiological outcomes using robot-assisted pedicle screw fixation and freehand technique in posterior lumbar interbody fusion: A prospective, randomized controlled trial. Int J Med Robot. 2018;14(4):e1917. emphasized that a follow-up of more than two years would be necessary to obtain more accurate data. Additionally, the authors argue that many participants did not have access to computed tomography in the postoperative period (only 28 in the minimally invasive group and 25 in the conventional group), a fact that may have influenced the conclusions. Kim et al.,2424. Kim HJ, Lee SH, Chang BS, Lee CK, Lim TO, Hoo LP, et al. Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test. Spine (Phila Pa 1976). 2015;40(2):87–94. in turn, suggested the differences in instrumentation (screw) used among the groups and the fact that operating time was not included in the performance quality measurement as possible limitations of the study. The third clinical trial selected,2828. Wang J, Zhou Y, Zhang ZF, Qing Li C, Jie Zheng W, Liu J. Comparison of the clinical outcome in overweight or obese patients after minimally invasive versus open transforaminal lumbar interbody fusion. J Spinal Disord Tech. 2014;27(4):202–6. although controlled, was not randomized. This study reports only three complications in the group treated with the minimally invasive procedure and one in the conventional procedure group, without the need for repair or surgical revision. The authors concluded, then, that the minimally invasive fusion technique is safe and reliable, but this conclusion was made based on a non-randomized, small, and specific (overweight and obese patients) population. It is worth mentioning, however, that almost all the studies showed that there were no serious adverse effects related to the use of a minimally invasive technique. These findings are corroborated by cohort and prospective studies not considered in this systematic review.

The scarcity of clinical trials with a high level of evidence, verified through the preparation of this systematic review, was also the subject of discussion of Park et al.,3939. Park Y, Seok SO, Lee S Bin, Ha JW. Minimally invasive lumbar spinal fusion is more effective than open fusion: a meta-analysis. Yonsei Med J. 2018;59(4):524–38. in a meta-analysis that included nine prospective cohort studies published up until December 2017, involving the comparison between minimally invasive lumbar fusion and the conventional technique. The results found in this study show that minimally invasive lumbar fusion techniques are more effective than open techniques in the treatment of spondylolisthesis in terms of improving function and reducing rates of infection, blood loss, and hospitalization time. However, there was no significant difference in parameters such as pain improvement, fusion rates, complications, or need for subsequent surgeries. In contrast, the prospective study by Giorgi et al.,4040. Giorgi H, Prebet R, Andriantsimiavona R, Tropiano P, Blondel B, Parent H. Minimally invasive transforaminal lumbar interbody fusion with unilateral pedicle screw fixation (UNILIF): morbidity, clinical and radiological 2-year outcomes of a 66-patient prospective series. Eur Spine J. 2018;27(8):1933–9. which involved 66 participants and a two-year follow-up, reported satisfactory results obtained from the minimally invasive technique (fusion rate of 96.8% in radiographic analyses), with a low rate of postoperative complications (6.1%), demonstrating the need to conduct more robust studies to obtain significant and reliable results.

CONCLUSIONS

Although the level of evidence of most of the studies included makes it difficult to demonstrate efficacy and superiority among the surgical techniques reviewed, the findings around the minimally invasive procedure indicate a safe and reliable approach for the treatment of lumbar diseases. Many of the studies with lower levels of evidence present favorable results and add information to our understanding of the application of the technique and the instrumentation in rare and critical cases of lumbar disorders, while clinical trials, prospective studies and cohort studies may be more indicated and more reliable for the purpose of determining the best approach to choose for each patient in more generalized populations.

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  • Study conducted in the Department of Neurology and Neurosurgery of the Universidade Federal de São Paulo.

Publication Dates

  • Publication in this collection
    12 Oct 2020
  • Date of issue
    Oct-Dec 2020

History

  • Received
    05 Sept 2019
  • Accepted
    28 Apr 2020
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