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CTRI Number  CTRI/2025/02/080261 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 04/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Clinicoradiological Outcomes in Patients Undergoing Transforaminal Lumbar Intervertebral Fusion via Unilateral Biportal Endoscopy vs Open approach 
Scientific Title of Study   Comparison of Clinicoradiological Outcomes in Patients Undergoing Transforaminal Lumbar Intervertebral Fusion via Unilateral Biportal Endoscopy vs Open approach; an Open Non-Inferior Randomised controlled trial study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jahansha A 
Designation  Junior Resident 
Affiliation  AIIMS , patna 
Address  Orthopedics department, AIIMS patna, Patna

Patna
BIHAR
801507
India 
Phone  9745879012  
Fax    
Email  jahansha016@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Avinash Kumar  
Designation  Associate professor  
Affiliation  AIIMS patna  
Address  Orthopedics department, AIIMS patna, patna

Patna
BIHAR
801507
India 
Phone  8789483273  
Fax    
Email  dravinashk@aiimspatna.org  
 
Details of Contact Person
Public Query
 
Name  Dr Avinash Kumar  
Designation  Associate professor  
Affiliation  AIIMS patna  
Address  Orthopedics department, AIIMS patna, patna

Patna
BIHAR
801507
India 
Phone  8789483273  
Fax    
Email  dravinashk@aiimspatna.org  
 
Source of Monetary or Material Support  
Department of Orthopedics, Ground floor, AIIMS Patna Bihar, pin 801507, India  
 
Primary Sponsor  
Name  No sponsor  
Address  Nil 
Type of Sponsor  Other [nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jahansha A  AIIMS patna  Room 44,department of Orthopedics, AIIMS patna
Patna
BIHAR 
9745879012

jahansha016@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  TRANSFORAMINAL LUMBAR INTERVERTEBRAL FUSION VIA OPEN METHOD  patients who are diagnosed with degenerative spine disorders will undergo Thoracolumbar intervertebral fusion via open approach. patient will be followed up and will be evaluated on the basis of clinico radiological outcomes.  
Intervention  TRANSFORAMINAL LUMBAR INTERVERTEBRAL FUSION VIA UNILATERAL BIPORTAL ENDOSCOPY  patients who are diagnosed with degenerative spine disorders will undergo Thoracolumbar intervertebral fusion via Unilateral biportal endoscopic approach. patient will be followed up and will be evaluated on the basis of clinico radiological outcomes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age more than or equal to 18 years
degenerative spondylolisthesis at one level
Severe lumbar canal stenosis at one level
Recurrent prolapsed intervertebral disc at one level
Lytic listhesis at one level
Patients who are willing to follow up for a minimum of 12 months
 
 
ExclusionCriteria 
Details  Patient with tandem spinal stenosis
Patient with spondylodiscitis
Patient with disseminated active infection
Pregnant women
Patients with traumatic spinal injury, severe osteoporosis, spinal tumors.
Patients who are unfit to undergo spinal surgery
Patients having severe mental insufficiency-like those with Parkinsonism, Alzheimer’s disease and other neurological disorder.
Patients with adult spinal deformity like degenerative scoliosis or coronal imbalance
Patient with more than one level pathogenesis
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare clinico radiological outcomes of patients undergoing Transforaminal lumbar intervertebral fusion via open vs UBE method  preop, post-op day-01 , day 7,2 weeks, 6weeks,3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
By measuring the amount of graft obtained from both open & unilateral biportal endoscopy method in a syringe in terms of ml
Complications, immediate & late at 3 months & 6 months

 
immediate post op & at 3 months & 6 months
 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   21/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

TLIF stands for Transforaminal Lumbar Interbody Fusion, which is a widely performed spine surgery. TLIF corrects a variety of spinal conditions, such as disc herniation, degenerative disc disease, and spondylolisthesis. The purpose of this procedure is to stabilize the vertebra to prevent dangerous movement between the bones. TLIF creates a solid bone between neighbouring vertebra and eliminates abnormal movement between them; hence, it is widely used for stabilization and treatment of degenerative lumbar disease following failed conservative treatment.

 

For many years, the standard posterolateral lumbar interbody fusion (LIF) technique has been a successful surgical treatment for LDD. It involves a posterior or transforaminal approach. Transforaminal LIF (TLIF) and posterior LIF (PLIF) might cause a considerable loss of posterior anatomic features, requiring a lengthy recovery period, even though they may stabilize the operated spinal segments and relieve neurologic issues.

 

The recently developed biportal endoscopic (BE) spinal surgical approach divides the working and viewing channels by making two independent incisions, thereby enabling continuous fluid perfusion. This technique allows for a broad field of vision and dynamic manipulation of the instruments. BE surgery can be used to treat spinal discectomy, spinal decompression, and additional LIF surgery (BE-LIF). BE-LIF and the minimally invasive


TLIF (MI-TLIF), which is based on tubular retractor devices, are similar techniques. It allows for direct neural decompression by facetectomy, discectomy, and laminectomy (ipsilateral and contralateral), as well as indirect neural decompression via spondylolisthesis reduction and disc space restoration.

 

The extra benefit of UBE surgery not requiring blind endplate preparation, which removes the possibility of endplate violation, is one significant advantage of UBE TLIF over uniportal fusion when the cage insertion is aided by fluoroscopic guidance. Moreover, a more thorough disc preparation can be carried out by directly seeing the endplate. Furthermore, compared to uniportal trans-Kambin methods, there is a reduced risk of exiting nerve root injury since direct visibility can be acquired during cage insertion. Less muscle injury and surgical insult to the patient compared to open and tubular procedures is another possible advantage of UBE fusion. According to Kang et al.’s research, on postoperative days 1 and 2, UBE TLIF results in a lower inevitable systematic inflammatory response (CRP and CPK). Others have also discovered that the UBE fusion group’s post-operative CRP is noticeably lower than the MT-TLIF group’s.These findings suggest that by reducing soft tissue trauma, UBE surgery reduces systemic inflammatory response. UBE surgeons think that because there is less systemic inflammation, patients may experience less pain following surgery and have a better quality of life in the early postoperative phase. The published research supports this notion by demonstrating the benefits of UBE fusion in the early post-operative phase. When it comes to back discomfort in the first month following surgery, UBE fusion groups score higher on the VAS scores than the MI TLIF group. Nevertheless, there is no discernible difference in these two groups’ back pain VAS scores at the final follow-up.

 

In their study, Gatam et al. also found that the UBE fusion group had statistically significant improvements in back pain,VAS levels up to three months after surgery. There was no discernible difference between MIS-TLIF and VAS back pain at 6 and 12 months.

 

Although some studies published that only VAS back pain showed differences in early follow-up period, other studies found a bigger improvement in ODI in the UBEgroup up to 1 month. In addition to patient report outcome, the UBE fusion group’s length of stay was shown to be significantly less than that of the MI-TLIF and open PLIF surgical groups due to decreased subjective discomfort.

 

The fusion rate in UBE TLIF is a concern because of the constant fluid irrigation pressure. Osteoblast-rich cells at the fusion bed may be washed off by constant fluid. Luckily, the literature does not support this belief. Comparable to MIS-TLIF, acceptable fusion rates have been obtained with UBE TLIF.

 

The UBE TLIF procedure is a novel surgical approach that carries a steep learning curve and may lead to increased rates of complications. On the other hand, the available data does not indicate a statistically significant difference between the MT-TLIF group and the UBE fusion group with respect to the rates of neurological impairment, cage subsidence, epidural hematoma, dural rupture, and overall surgical complications. If the irrigation fluid outflow is blocked, pressure from the fluid may accumulate in the paraspinal muscles. Muscle death similar to compartment syndrome may happen when the compartment pressure rises. A rise in intracranial pressure is another possible outcome. Seizures, headaches, neck stiffness, and vomiting are some of the signs of elevated ICP. It’s important to maintain a steady outflow and avoid raising the irrigation fluid pressure above 50 mmHg.

 

Unlike uniportal endoscopic spine operations, UBE transforaminal endoscopic fusion offers accurate surgery without instrument size limitations, thereby addressing the fundamental problem of mobility in tubular minimally invasive spinal surgery. This suggests a hopeful future for the procedure. This is particularly helpful during fusion surgery when precise intervertebral disc management is needed and additional bony work is involved. The development of robotic surgery and navigation may help reduce the learning curve in UBE fusion,


and advances in intervertebral cage technology, including expandable cage systems, ultrasonic knives, and improved biologics, could ultimately lead to better fusion outcomes.

 

With less post-operative pain and a shorter hospital stay, UBE lumbar fusion is a relatively recent approach to lumbar fusion that primarily offers less intraoperative blood loss and faster recovery. Still, there is no greater risk of problems with long-term clinical and radiological results compared to open and MIS fusion procedures. None of the recently published research had a longer than one-year follow-up period, and the majority are retrospective studies. Therefore, additional high-quality randomized control trials with extended follow-up are required to corroborate these results and assess the safety and effectiveness of UBE fusion in situations of multilevel fusion, adjacent segment illness, and revision scenarios.

 
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