| CTRI Number |
CTRI/2025/03/082963 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical and Radiological study to compare outcomes of p cage(an implant) placement in the center versus away from the center in patinets undergoing open or endoscopic spine surgery |
|
Scientific Title of Study
|
Clinicoradiological Comparison of Sagittal versus Parasagittal placement of cage in patient undergoing
Open or Endoscopic Transforaminal lumbar interbody fusion (TLIF) surgery: A Randomized control trial |
| 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 Avinash Kumar |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Orthopedics department ,AIIMS Patna, Patna
Patna
BIHAR
801507
India |
| Phone |
8789483273 |
| Fax |
|
| Email |
dravinashk@aiimspatna.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash Kumar |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences |
| 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 |
All India Institute of Medical Sciences |
| Address |
Orthopedics department ,AIIMS Patna, Patna
Patna
BIHAR
801507
India |
| Phone |
8789483273 |
| Fax |
|
| Email |
dravinashk@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| AO Spine Asia Pacific
Unit 1310-11, Tower 1, Millennium City 1, 388 Kwun Tong Road, Kowloon, Hong Kong,China |
|
|
Primary Sponsor
|
| Name |
AO Spine Asia Pacific |
| Address |
Unit 1310-11 Tower 1, Millennium City 1, 388 Kwun Tong Road, Kowloon, Hong Kong |
| Type of Sponsor |
Other [Global not for profit organization] |
|
|
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 Avinash Kumar |
All India Institute of Medical Sciences Patna |
OPD block ,Department of Orthopedics ,room number 45,Phulwarisharif, near Walmi Institute
Patna
BIHAR |
8789483273
dravinashk@aiimspatna.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committe,AIIMS Patnae |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Parasagittal placement of cage |
patients who are diagnosed with certain spine pathology will undergo open or endoscopic Trans foraminal lumbar interbody fusion with parasagittal placement of cage in the intervertebral space and patient will be followed up at 1st ,3rd and 6th month with x rays,Ncct and SF-36 scores so ,total duration for intervention will be 6 months |
| Comparator Agent |
sagittal placement of cage |
patients who are diagnosed with certain spine pathology will undergo open or endoscopic transforaminal lumbar interbody fusion with sagittal placement of cage in the intervertebral space and the patient will be followed up at 1 St ,3rd and 6 th months ,so total duration of intervention will be 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1-Age more than 18 years
2-Degenerative spondylolisthesis
3-Severe lumbar canal stenosis
4-Recurrent prolapsed intervertebral disc
5-Patients who are willing to follow up for a minimum of 12 months |
|
| ExclusionCriteria |
| Details |
1-Patient with tandem spinal stenosis
2-Patient with spondylodiscitis
3-Patient with disseminated active infection
4-Pregnant women
5-Patient with traumatic spinal injury, spinal tumor
6-Patient who are unfit to undergo spinal surgery
7-Patient having severe mental insufficiency-like those with Parkinsonism, Alzheimer disease and other neurological disorder.
8-Patient with adult spinal deformity like degenerative scoliosis or coronal imbalance |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1-Post operative measurement of Global lumbar lordosis using Plain radiograph
2-Quantitative measurement of subsidence of the cage on NCCT scan
3-Signs of fusion through Modified Lees criteria on NCCT
4-SF 36 score to measure the Functional outcome |
1month,3 month,6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To enlist the complications intraoperative and post operatively such as
1-general anasthesia comlication
2-excessive blood loss
3-infection
4-spinal cord/nerve injury
5-failure of fusion
6-displacement of implanted cage
7-continued lower back pain |
1 month,3 month,6 month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/03/2025 |
| Date of Study Completion (India) |
22/12/2025 |
| Date of First Enrollment (Global) |
22/03/2025 |
| Date of Study Completion (Global) |
22/12/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Transforaminal Lumbar Interbody Fusion (TLIF) is indicated in a variety of spinal conditions such as
disc herniation, degenerative disc disease, and spondylolisthesis which leads to facetal instability. TLIF
creates a solid bone between neighboring vertebra and eliminates abnormal movement between them
hence it is widely used for stabilization, fusion and treatment of degenerative lumbar disease following
failed conservative treatment. While cages are commonly used for intervertebral fusion in TLIF
providing mechanical support for the anterior column. These cages aid in the restoration of lumbar
lordosis by maintaining the height of the intervertebral space and enhancing sagittal alignment. This
results in the restoration of disc height and indirect decompression of the neuroforamen. Good
clinical results and fusion rates were documented in earlier research after TLIF using cages. However, there may be some adverse consequences if a single cage is implanted on one side. In summary of the paper published by Quigley et al in 2008 on a synthetic spine model, under axial
loading circumstances, Leopard carbon-fiber interbody cages positioned laterally exhibit more
strain upon posterior instrumentation and a quicker load to failure than cages more centrally
located.1
Cage position and cage subsidence were found to be associated by Abbushi et al., who
compartmentalized vertebrae into postero-lateral, medio-lateral, antero-lateral, postero-medial, medio- medial, or antero-medial for placement of cages.2 The medio-medial cage position showed the
highest cage migration, followed by the postero-lateral and postero-medial cage position. There was
roughly 5 percentage of cage subsidence of >3mm which was observed to be higher in medial than
lateral
position of cage. The main reason for the same is end plate erosion while preparing the disc and
weaker cancellous bone in the central part of the vertebrae. According to anatomical research, the vertebral endplate thickens and becomes denser as it moves
towards the periphery. An endplate’s postero-lateral portion is its strongest section, while its centre is
its weakest, according to biomechanical and anatomical data. Studies using cadavers provided proof of
this theory. Labrom et al. demonstrated that greater construct stiffness was achieved by two
smaller titanium mesh cages positioned postero-laterally in a cadaver spine as opposed to centrally
located interbody cages.3
This goes in contrast with Comer et al who concluded in a cadaveric model constructs with lateral cage
placement showed comparable stiffness to centrally positioned ones in flexion, extension, lateral
bending, and torsion, but having much less stiffness under compression. It follows that the
coronal location of the cage is thought to have less of an effect on Posterior cage migration.4
However there has been no published data of a prospective study which compare clinico-radiological
outcome of sagittal and parasagittal placement of cage with Bilateral posterior instrumentation. With
the advent of UBE(Unilateral Biportal endoscopic spine surgeries) which further necessitates to further
study the fusion rates and biomechanical difference among the two groups. UBE with its advantage
of placement of cage under vision allow us less play and limits the surgeon in sagittal placement of
the
cage. The study aims to conclude the differences between the cage position and possible
complications which could occur through a RCT |