COMPARITIVE ANALYSIS OF FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF OPEN TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) AND MIS (MINIMALLY INVASIVE) TLIF: An OPEN LABEL PARALLEL RANDOMISED CONTROLLED STUDY

Study will be conducted at Orthopedics department, AIIMS NAGPUR. Patients presenting to orthopedics OPD with backpain and lower limb radiculopathy/claudication not responding to conservative measures will be screened for exclusion and inclusion criterion as per study. The demographic data will be recorded in the case record sheet. The patient will be informed about the study and informed consent will be recorded in the standard format. The patients will be randomized to undergo surgery with either of the two methods (OPEN TLIF or MIS TLIF). It will be an open label study. The participants, as well as the investigator assessing the outcomes, will be aware of the group allotment . Visual Analog scale score for pain and Oswestry disability index will be documented preoperatively for all patients.  The patients will be randomized into 2 treatment groups. All patients would have done X rays Lumbar spine AP and Lat (Static and Dynamic views) and MRI Lumbosacral spine with whole spine screening for their diagnosis. Surgery will be performed under general anesthesia in prone position. In case of open TLIF the interbody cage will be inserted from the side which is more symptomatic and if both sides are equally symptomatic then from the left side.  Patients in both the groups would mobilize out of bed from post operative day 1 with lumbosacral belt support. Patients will be started with isometric back and abdominal exercises after 2 weeks. After 1-month patients will be asked to stop the use of belt. Any post operative neurological complication will be documented. The patients will be followed at 2 weeks, 1 month, 3 months and 6 months. All the patients will be assessed clinically and radiologically at all the follow-ups. The functional outcome will be assessed using the Visual Analog Scale and Oswestry Disability index at the each follow up. Radiologically assessment will be done using Anteroposterior and lateral X-rays. Fusion will be determined by using Bridwell Interbody fusion grading system in AP and lateral x-rays and time to fusion will be documented. Data will be entered in an MS Excel spreadsheet and analyzed using SPSS software. Categorical variables such as gender will be described as frequencies and percentages. Continuous variables such as age, and functional score measured through various indices will be summarized as mean and Standard deviation. The intraoperative time, Intraoperative blood loss, hospital stay and Visual Analog score for pain on follow up, number of complications arising with operative method and post-op reduction in hemoglobin values will be evaluated using Unpaired t test (given that these parameters are distributed normally). In case of non-normal distribution of the mentioned parameters, Mann-Whitney U test will be used. A p value of <0.05 will be considered significant.