| CTRI Number |
CTRI/2025/06/089874 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
28/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of outcome lumbar spine vertebral fusion surgery using Micro and Nano-textured Titanium Cage implant versus PEEK material cage implant |
|
Scientific Title of Study
|
Assessment of lumbar fusion and its significance on functional outcome following the usage of Micro and Nano-textured Titanium Cages - A prospective single–blinded randomized controlled pilot study trial comparing nanotextured Titanium cages versus PEEK cages. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Imtiaz Ghani |
| Designation |
Consultant |
| Affiliation |
Room num 35, Spine surgery unit,Apollo main hospital, Greams lane, Thousand lights, Chennai. |
| Address |
Spine surgery unit,
Apollo main hospital,
Greams lane, Thousand lights, Chennai.
Room num 35, Spine surgery unit, Apollo main hospital, Greams lane, Thousand lights, Chennai, Tamilnadu-600006
Chennai
TAMIL NADU
600006
India |
| Phone |
09585232835 |
| Fax |
|
| Email |
imtiazghani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Imtiaz Ghani |
| Designation |
Consultant |
| Affiliation |
Room num 35, Spine surgery unit, Apollo main hospital, Greams lane, Thousand lights, Chennai, Tamilnadu-600006 |
| Address |
Spine surgery unit,
Apollo main hospital,
Greams lane, Thousand lights, Chennai.
Room num 35, Spine surgery unit, Apollo main hospital, Greams lane, Thousand lights, Chennai, Tamilnadu-600006
Chennai
TAMIL NADU
600006
India |
| Phone |
09585232835 |
| Fax |
|
| Email |
imtiazghani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Imtiaz Ghani |
| Designation |
Consultant |
| Affiliation |
Room num 35, Spine surgery unit, Apollo main hospital, Greams lane, Thousand lights, Chennai, Tamilnadu-600006 |
| Address |
Spine surgery unit,
Apollo main hospital,
Greams lane, Thousand lights, Chennai.
Room num 35, Spine surgery unit, Apollo main hospital, Greams lane, Thousand lights, Chennai, Tamilnadu-600006
Chennai
TAMIL NADU
600006
India |
| Phone |
09585232835 |
| Fax |
|
| Email |
imtiazghani@gmail.com |
|
|
Source of Monetary or Material Support
|
| M/s India Medtronic Private Limited, Plot No 609
Survey/Shed-188 (part) Chamunda
Compound,Kasheli Village, Dist Thane, Bhiwandi
421301 Maharashtra, Thane, Maharashtra (India) -
421301 Telephone No.: 22330747001 FAX:
22330747001 |
|
|
Primary Sponsor
|
| Name |
Medtronics India |
| Address |
1261,Solitaire Corporate Park,Bldg No 12, 6th Floor |
Andher-Ghatkopar link road Andheri East | Mumbai, Maharashtra 400093 | India |
| Type of Sponsor |
Other [MEDICAL IMPLANT COMPANY] |
|
|
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 |
| Imtiaz Ghani |
Apollo hospital |
Apollo main hospital
Greams Lane, 21 Greams Road, Thousand Lights, Chennai
Chennai
TAMIL NADU |
09585232835
imtiazghani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETICAL COMMITTEE-CLINICAL STUDY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M995||Intervertebral disc stenosis of neural canal, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Spine fusion surgery using PEEK cage |
One time surgical procedure of spine fusion surgery using pedicle screws and PEEK material cage implants for patients with lumbar disc degeneration. After surgery patients are periodically reviewed at 3rd month, 6th month and 12th month to assess lumbar fusion. |
| Intervention |
Spine fusion surgery using Titanium nano technology cage implant |
One time surgical procedure of spine fusion surgery using pedicle screws and Titanium nano technology cage implants for patients with lumbar disc degeneration. After surgery patients are periodically reviewed at 3rd month, 6th month and 12th month to assess lumbar fusion. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Subject is scheduled to undergo interbody spinal fusion surgery using either the nanotechnology titanium cage or PEEK cage in conjunction with local autograft and supplementation with a pedicle screw system
The subject must in the investigators opinion be psychosocially mentally and physically able to fully comply with this protocol including the required follow-up visits and have the ability to understand and give written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Subjects with previous lumbar fusion surgery.
2. Subject has inadequate tissue coverage over the operative site.
3. Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
4. Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
5. Subject has an active local or systemic infection.
6. Subject has a metal sensitivity/foreign body sensitivity.
7. Subject is morbidly obese, defined as a body mass index (BMI) greater than 45.
8. Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
9. Subject is currently involved in another investigational drug or device study that could confound study data.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of lumbar spine fusion |
3 months, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical improvement after spoine fusion |
3 months, 6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 4 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The purpose of this randomized controlled trial is to assess and compare radiographic fusion and clinical outcome in patients who undergo Transforminal lumbar interbody fusion procedure,supplemented with pedicle screw instrumentation using one of the following interbody cages Titanium cages with roughened micro and nano textured surface cages vs poly-ether-ether-ketone cages This study will capture clinical and radiological outcomes on patients upto 1 year postoperatively Both cages will be used in conjunction with a autograft locally harvested during the decompression procedure |