| CTRI Number |
CTRI/2025/08/093548 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| 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
|
COMPARING TWO TECHNIQUES OF SPINE SURGERY IN DISC PROLAPSE
|
|
Scientific Title of Study
|
Comparison of clinical outcomes of unilateral biportal endoscopic technique and open technique of discectomy in lumbar disc herniation |
| 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. Rupjyoti Dutta |
| Designation |
Postgraduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Orthopaedics, Lok Nayak Hospital, New Delhi-110002, Central Delhi
Central
DELHI
110002
India |
| Phone |
8876470600 |
| Fax |
|
| Email |
rupdutta.tez@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VINOD KUMAR |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Orthopaedics, Lok Nayak Hospital, New Delhi-110002, Central Delhi
Central
DELHI
110002
India |
| Phone |
9968604321 |
| Fax |
|
| Email |
drkumarvinod@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VINOD KUMAR |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Orthopaedics, Lok Nayak Hospital, New Delhi-110002, Central Delhi
Central
DELHI
110002
India |
| Phone |
9968604321 |
| Fax |
|
| Email |
drkumarvinod@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, Delhi Gate, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department of Orthopaedics, Lok Nayak Hospital, New Delhi-110002, Central Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Rupjyoti Dutta |
Lok Nayak Hospital , New Delhi |
Ward 3A, 3B, 3C, Department of Orthopaedics, Maluana Azad Medical College
Central
DELHI |
8876470600
rupdutta.tez@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College Institutional Ethics committee |
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 |
Open lumbar discectomy |
In Open Lumbar Disectomy, a midline incision is made, deeper tissues are dissected, and interlaminar space exposed. Bone and ligamentum flavum are removed to access the spinal canal. The herniated disc is excised after annulotomy, followed by nerve root decompression and layered wound closure. |
| Intervention |
Unilateral Biportal Technique |
In Unilateral Biportal endoscopic technique, the patient is positioned prone under general anesthesia. Two portals are created—one for endoscopic visualization with continuous irrigation and one for instrument manipulation. Partial laminotomy, annulotomy, and disc fragment removal are performed with minimal muscle dissection, followed by root decompression and layered closure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with compressive lumbar radiculopathy due to lumbar disc herniation not responding to at least 6 weeks trial of standard conservative management |
|
| ExclusionCriteria |
| Details |
Degenerative lumbar scoliosis, Spinal stenosis, Calcified ligamentum flavum, Segmental instability of lumbar spine, Psychosomatic pain syndromes, Previously operated patients for disc herniation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visaual Analoque score between the 2 groups |
The patients will be assessed at baseline, at postoperative 14 ± 2 days, 6 weeks, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the extent of tissue damage caused by Unilateral Biportal Endoscopic discectomy and Open discectomy by measuring biochemical markers of tissue injury |
Baseline, Postoperative Day 1, Postoperative Day 3 |
| To compare amount of blood loss during Unilateral Biportal Endoscopic discectomy and open discectomy |
Baseline Haemoglobin, Postoperative day 1 and Postoperative Day 2 |
| To compare hospital stay after Unilateral Biportal Endoscopic discectomy and Open Discectomy |
Number of days admitted after surgery |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
10/09/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Lumbar disc herniation (LDH) is a prevalent cause of lower back pain and sciatica, primarily occurring at the L4-L5 or L5-S1 levels. While most cases respond to conservative treatment, surgery is indicated for patients with persistent symptoms or neurological deficits. The standard surgical approach, open lumbar discectomy (OLD), is effective but associated with higher tissue damage, postoperative pain, and longer recovery. Minimally invasive techniques like Unilateral Biportal Endoscopic Discectomy (UBE) offer advantages such as reduced muscle trauma, shorter hospital stays, and faster recovery.
This randomized controlled study will be conducted at Maulana Azad Medical College, comparing clinical outcomes of UBE and OLD in patients aged 18–60 years with confirmed LDH unresponsive to conservative treatment. The primary outcome assessed is the change in Visual Analogue Score (VAS) at 2 weeks and 6 months. Secondary outcomes include Oswestry Disability Index (ODI), Macnab score, intraoperative blood loss, surgical duration, hospital stay, and biochemical markers of muscle injury (CPK, LDH, CRP, ESR). With a sample size of 11 patients per group, the study aims to evaluate the invasiveness and efficacy of both techniques. Follow-ups are scheduled at 2 weeks, 6 weeks, 3 months, and 6 months to monitor recovery and outcomes. |