| CTRI Number |
CTRI/2026/02/104106 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Outcome of a Less Invasive Spine Stabilization Surgery in 47 Patients |
|
Scientific Title of Study
|
Inter-muscular postero-lateral minimal invasive open approach revisited: Spectrum of possibilities and Outcomes of stabilization. A retrospective observational study of 47 patients. |
| 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 Ajay Krishnan |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
2nd floor, Research Department ,Stavya Spine hospital and Research Institute , Ellisbridge ,Mithakhali,Ahmadabad, GUJARAT,380006,India Ahmadabad GUJARAT 380006 India |
| Phone |
09824302768 |
| Fax |
|
| Email |
drajaykrishnan@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajay Krishnan |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
2nd floor, Research Department ,Stavya Spine hospital and Research Institute , Ellisbridge ,Mithakhali,Ahmadabad, GUJARAT,380006,India
GUJARAT 380006 India |
| Phone |
09824302768 |
| Fax |
|
| Email |
drajaykrishnan@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Ajay Krishnan |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
2nd floor, Research Department ,Stavya Spine hospital and Research Institute , Ellisbridge ,Mithakhali,Ahmadabad, GUJARAT,380006,India
GUJARAT 380006 India |
| Phone |
09824302768 |
| Fax |
|
| Email |
drajaykrishnan@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
2nd floor, Research Department,Stavya Spine hospital andResearch Institute Ellisbridge MithakhaliAhmadabad,GUJARAT,380006,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ajay Krishnan |
Stavya Spine Hospital & Research Institute |
2nd floor, Research Department ,Stavya Spine hospital and Research Institute ,Ellisbridge ,Mithakhali,Ahmadabad,GUJARAT,380006,India Ahmadabad GUJARAT |
09824302768
drajaykrishnan@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Stavya Spine hospital & Research Institute IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M532||Spinal instabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Traumatic fractures
2. Fragility fracture
3. Pathological fractures of different etiology, infective spondylodiscitis and metastasis/primary tumour
4. Patients who were poorer and couldn’t afford a percutaneous screws system and neither wanted to pursue the subsidised health schemes.
|
|
| ExclusionCriteria |
| Details |
1. Patients with incomplete records
2. Previously operated at same/adjacent levels
3. Patients presented with other co-existing spinal regions/ joints/ metabolic/ congenital/ diseases that could significantly influence the outcome of the patient.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. All the patients were assessed thoroughly and demographic details (age, sex, BMI), primary diagnosis, pre-operative neurology (ASIA grading), classification of disorder, and spinal region were recorded.
2.To evaluate intra operative parameters in form of estimated blood loss ,duration of surgery & intra operative time for screw placement
3.To evaluate post operative parameters inn the form of length of hospital stay, requirement of post operative analgesia ,post op complications (if any) |
Baseline, intra-operative, and follow-up data at 3 months, 6 months, 12 months, and 24 months are required. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="47" Sample Size from India="47"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2026 |
| 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) |
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
|
This retrospective observational study evaluates the clinical and radiological outcomes of pedicle screw fixation using the postero-lateral intermuscular minimally invasive open approach (PLOA) in patients with thoraco-lumbar spinal pathologies requiring stabilization without extensive decompression. Conventional posterior midline open approach is associated with significant muscle dissection, blood loss, post-operative pain, and delayed recovery. PLOA follows a muscle-sparing anatomical plane, aiming to reduce tissue damage while allowing accurate pedicle screw placement. A total of 47 non-consecutive patients operated between January 2016 and January 2022 were included, with a minimum follow-up of 24 months. Pre-operative demographic and clinical parameters, intra-operative variables (blood loss, operative time, screw accuracy), and post-operative outcomes (analgesic requirement, hospital stay, radiological correction, complications, and implant status) were analyzed. Standard classification systems were used based on pathology (trauma, tumor, infection). The study aims to assess the safety, effectiveness, and indications of PLOA as a cost-effective alternative to conventional and percutaneous techniques, especially in resource-limited settings. |