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1. Evaluation of Lumbar Lordosis Correction Following TLIF Surgery in Patients with Spondylolisthesis and its cor-relation with Early Functional outcome: A Prospective analytical Study. Saroj Chandra Dahal Spine Fellow

2. Background Degenerative disc disease (DDD) is a g lobal health issue with prevalence ranging from 40% to 60%. 1 52.6% of Nepalese individuals aged 40-70 years are affected by DDD. 2 Transforaminal Lumbar Interbody Fusion (TLIF) is a well-established surgical technique to treat DDD. P rimary objectives of TLIF is to restore lumbar lordosis, which is essential for achieving proper sagittal balance and optimizing long-term clinical outcomes 3 C orrection of lumbar lordosis is critical because it influences postoperative spinal alignment, which directly impacts patient outcomes, including pain relief, functional recovery, and overall quality of life 4,5 Hoy D, Bain C, Williams G, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012;64(6):2028-2037. Paudel ML, Bhandari R, Chaudhary P, et al. Prevalence of lumbar disc degeneration among the elderly population in Nepal. J Nepal Health Res Counc . 2018;16(38):287-291. Harms J, Rolinger H. A one-stage procedure in operative treatment of spondylolistheses: Dorsal traction-reposition and anterior fusion (author’s transl ). Z Orthop Ihre Grenzgeb . 1982;120(3):343-347. Glassman SD, Bridwell K, Dimar JR, Horton W, Berven S, Schwab F. The impact of positive sagittal balance in adult spinal deformity. Spine. 2005;30(18):2024-2029. Schwab F, Patel A, Ungar B, Farcy JP, Lafage V. Adult spinal deformity–postoperative standing imbalance. Spine. 2010;35(20):2224-2231

3. Problem Statement A correction of 10° to 15° in lumbar lordosis results in significant improvements in pain and functional status 6 . However, insufficient correction (less than 10°) could lead to poor clinical outcomes, whereas overcorrection (greater than 20°) might increase the risk of adjacent segment disease 7 Ha Y, Marigi E, Kim JH, et al. Impact of lordosis restoration on segmental correction and patient outcomes following lumbar fusion surgery. Spine J. 2014;14(5):756-764. Le Huec JC, Aunoble S, Philippe L, Hresko T. Pelvic parameters: Origins and relevance. Eur Spine J. 2011;20(Suppl 5):564-571

4. Rationale T he specific impact of lumbar lordosis correction following TLIF in South Asians remains underexplored. Assessing the extent of lordosis correction in the Nepalese population is crucial, given the high prevalence of DDD and the variability in observed clinical outcomes. This study aims to evaluate lumbar lordosis correction following TLIF surgery in a tertiary care center, providing valuable insights that could inform surgical practices and enhance patient care in similar contexts

5. Objectives

6. Objectives General To evaluate the Lumbar Lordosis Correction Following TLIF Surgery in Patients with Spondylolisthesis and its cor-relation with early functional outcome. Specific To measure the degree of lumbar lordosis correction post-TLIF surgery. To measure the degree of segmental lumbar lordosis correction post TLIF surgery To measure the Visual Analogue score and ODI score

7. Research Methodology

8. Research Methodology Study Design: Prospective analytical study Study Duration: Nine month from date of IRC clearance Study Population: Patients with spondylolisthesis undergoing short- segment (1-, 2-, or 3-level) TLIF procedures at Orthopedics department of B&B Hospital Study Site: B&B Hospital, Gwarko , Lalitpur Sampling: Convenient consecutive Sampling Method

9. Research Methodology Sample size calculation * Sample size formula and calculation: n=(Zα/2​× σ ​) 2 / Δ 2 = 41 where, Zα/2 = 1.96, constant for 95% confidence interval σ ​(Postoperative standard deviation) = 6.66 from previous study by Jagannathan et al 11 E= 2% margin of error   * 1 . Jagannathan J, Sansur CA, Oskouian RJ, Fu KM, Shaffrey CI. RADIOGRAPHIC RESTORATION OF LUMBAR ALIGNMENT AFTER TRANSFORAMINAL LUMBAR INTERBODY FUSION. Neurosurgery [Internet]. 2009 May [cited 2024 Aug 14];64(5):955–64. Available from: https:// journals.lww.com /00006123-200905000-00029

10. Procedure Ethical approval from Institutional Review Committee (B&B IRC) Informed written consent will be taken from all the participants Subjects meeting the eligibility criteria will be enrolled in the study

11. INCLUSION CRITERIA Age greater than 40 years, Preoperative diagnosis of degenerative disc disease at one or two contiguous levels with or without symptomatic lumbar spondylolisthesis (up to grade 1) and failed conservative treatment (at minimum duration of 6 months). All patients with radiculopathy or neurogenic claudication with central spinal or neuroforaminal stenosis with or without spondylolisthesis and underwent short- segment (1-, 2-, or 3-level) TLIF procedures

12. EXCLUSION CRITERIA Spinal Trauma Inflammatory arthritis Prior fusion or previous spine surgery Spinal Tumor.

13. Study Procedure Radiographic Assessment S tanding anterior-posterior , lateral and dynamic (flexion and extension lateral) radiographs of the lumbosacral spine. Preoperative LL and Post operative LL at 3 rd post operative day, 6 wks and 3 month The lumbar lordosis will be measured using Angulus software Version 4.3.2

14. Clinical Assesment Oswestry Disability Index (ODI) and Visual Analogue S core (VAS) will be measure preoperative ,immediate post operative ,at 6 Wks and 3months. Evaluate the correlation with correction of LL.

15. Operative Procedure : TLIF S tandard open transforaminal lumbar interbody fusion will be performed. Performed under general anesthesia in position prone on a well-padded operating table with hips in extended position A ntibiotic cefuroxime will be given. The dissection will carried subperiosteally to the tips of the transverse processes and sacral ala. Posterior instrumentation with pedicle screw. A laminectomy will be performed, and neural decompression was completed. Then facetectomy will performed and the disc space will exposed on the most symptomatic side. The neural elements will be retracted and an annulectomy will be performed. D iscectomy will be performed using pituitaries and disc space shavers

16. The end plates will be prepared with a rasp and angled osteotomes. Local bone graft from the laminectomy were placed through a funnel into the anterior disc space. If necessary, a facetectomy was performed on the contralateral side. the interbody cage will be packed with the bone graft and then placed in the interbody space, across the mid-line. The remaining bone graft will be placed over the contralateral transverse processes and lateral facets. Appropriate size rods will be selected and contoured, placed in the tulip heads, and then tightened in compression using the manufactures recommended torque symptomatic side. The wound bed will beirrigated with saline and closed over a drain.

17. Data collection and Analysis C ollected in the paper based proforma R ecorded in Excel sheet. T ransferred to SPSS for analysis. The tools for statistical analysis will be used as per needed. Means and standard deviations are calculated for continuous variables and Percentages for categorical variables. .

18. A paired t test is used to evaluate changes between the baseline (preoperative) values and individual post-operative values for lumbar lordosis ,ODI score and VAS C orrelations between the clinical outcome and lumbar lordosis through Mann-Whitney U -test and Pearson’s correlation analysis. S tatistical significance is indicated as a p -value <0.05.

19. Data Collection Tools

20. Limitations Single centered study Small sample size Long term effectiveness cannot be assessed

21. INFORMED CONSENT FORM I…………,…..year old, from………………….have been explained thoroughly about the study, Evaluation of Lumbar Lordosis Correction Following TLIF Surgery in Patients with Degenerative Disc Disease: A Prospective cross-sectional Study and had no obligation in helping in this research. My participation is voluntary, and I have been clearly explained by the investigator that I can withdraw at any point of time from this research without any obligation. I also give permission to publish this research maintaining confidentiality regarding my identity. Thumb print (Right) Thumb print(Left) Name- Address- Signature-

22. Thank you