| 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
|
|
|
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
|
|
|
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. |