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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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