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CTRI Number  CTRI/2024/10/075021 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 09/10/2024
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 the Femoral Tunnel Position and Stability following ACL Reconstruction using Outside In V/s Antero Medial Portal Technique 
Scientific Title of Study   Comparing the Femoral Tunnel Position and Stability following ACL Reconstruction using Outside In V/s Antero Medial Portal Technique-a Randomised Controlled 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  Sagar Setia 
Designation  Junior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES,JODHPUR 
Address  Department of Orthopaedics,OPD Ground Floor A block,AIIMS Hospital,Basni Industrial area,Jodhpur-342005

Jodhpur
RAJASTHAN
342005
India 
Phone  7688918490  
Fax    
Email  sagarsetia37@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sumit Banerjee 
Designation  Professor,Department of Orthopaedics 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES,JODHPUR 
Address  OPD Ground Floor A Block,Department of Orthopaedics ,AIIMS Hospital,Basni Industrial area,Jodhpur-342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9910895314  
Fax    
Email  drsumitbanerjee@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumit Banerjee 
Designation  Professor,Department of Orthopaedics 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES,JODHPUR 
Address  OPD Ground Floor A Block,Department of Orthopaedics ,AIIMS Hospital,Basni Industrial area,Jodhpur-342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9910895314  
Fax    
Email  drsumitbanerjee@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences(AIIMS),Jodhpur 
 
Primary Sponsor  
Name  Dr Sumit Banerjee 
Address  OPD Ground Floor A Block,Department of Orthopaedics,AIIMS Hospital,Basni Industrial area,Jodhpur-342005 
Type of Sponsor  Other [Individual] 
 
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 Sumit Banerjee  AIIMS Jodhpur  AIIMS Hospital, Basni Industrial area,Jodhpur-342005
Jodhpur
RAJASTHAN 		 9910895314

drsumitbanerjee@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(Clinical Trial)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ACL Reconstruction Procedure-using Antero Medial Approach: 1 hour duration   First Method of Femoral Tunnel Drilling in ACL Reconstruction procedure -Antero Medial Approach is Being compared to second method -Outside In approach in terms of femoral tunnel position and Graft Stability 
Comparator Agent  ACL Reconstruction procedure-using Outside In approach : 1 hour duration  Second Method of Femoral Tunnel Drilling in ACL Reconstruction procedure -Outside In Approach is Being compared to first method -Antero Medial approach in terms of femoral tunnel position and Graft Stability 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients undergoing Primary ACL Reconstruction
and have skeletal maturity
 
 
ExclusionCriteria 
Details  Patients planned for revision ACL reconstruction
or having multi ligamentous injury

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare femoral tunnel position radiologically of patients planned for ACL reconstruction using either outside in vs. anteromedial femoral drilling  Immediate Pre-Op period,12 weeks,24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare graft stability in patients undergoing ACL reconstruction using either outside in vs. anteromedial femoral drilling techniques using functional outcome-post op status-clinical tests, scores & radiological aspects  Immediate pre-op period,12 weeks,24 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   20/10/2024 
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="6"
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 two most commonly used portal techniques for femoral canal during ACL reconstruction are-Anteromedial(AM) and Outside in(OI).

The utilization of conventional transtibial approaches in initial procedures may pose an increased risk of graft verticality, potentially resulting in issues such as knee instability and a higher likelihood of unfavorable clinical outcomes.

The AM portal technique involves the utilization of an additional AM portal for the individual drilling of the femoral tunnel


RESEARCH QUESTION

Which method provides better femoral tunnel position and stability -between anteromedial and outside in portal techniques?

AIM

To compare portal techniques -outside in vs. anteromedial on basis of femoral tunnel position and stability.

PRIMARY OBJECTIVE

  1. To compare femoral tunnel position radiologically of patients planned for ACL reconstruction using either outside in vs. anteromedial femoral drilling.

SECONDARY OBJECTIVE

To compare graft stability in patients undergoing ACL reconstruction using either outside in vs. anteromedial femoral drilling techniques using functional outcome -post op status-clinical tests, scores and radiological aspects.

STUDY PARTICIPANTS (CRITERIA OF SELECTION)


Inclusion criteria


  1. All patients undergoing Primary ACL Reconstruction

  2. All patients that have skeletal maturity.


Exclusion criteria


  1. Patients planned for revision ACL reconstruction

  2. Patients with history of knee trauma who have multi ligament injury

                                                          


STUDY PROCEDURE/PROTOCOL


  1. Informed written consent will be taken for using patient data.

  2. Patient satisfying the inclusion and exclusion criteria will be included in our study.

  3. For the patients who have already been treated, all hospital records of the patient including previous admission records, OPD evaluation sheets, clinical and radiological documents and photographs obtained during follow up will be thoroughly assessed.

  4. For ongoing patients, the current hospital records, radiographs, and findings at each

follow-up visit at OPD will be taken into the study.

  1. Patient will be admitted in ward and pre anesthetic checkup will be done and additional investigations as deemed necessary.

  2. The scoring systems-used in the protocol are the standard of care used in the department and data are available in the department records.

 
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