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CTRI Number  CTRI/2021/09/036470 [Registered on: 14/09/2021] Trial Registered Prospectively
Last Modified On: 10/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Effect of bone tunnel position on outcome of anterior cruciate ligament reconstruction 
Scientific Title of Study   Functional and magnetic resonance imaging based analysis of femoral and tibial tunnel orientation in arthroscopic assisted anterior cruciate ligament reconstruction 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Adarsh Tekumalla 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education 
Address  105,Minerva Heights, Manipal, Udupi
Madhav nagar, Manipal
Udupi
KARNATAKA
576104
India 
Phone  8056170108  
Fax    
Email  tekumalla.adarsh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sandeep Vijayan 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education 
Address  Department of Orthopaedics, Kasturba Medical College
Madhav nagar, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9449615291  
Fax    
Email  sandeep.vijayan18@gmail.com  
 
Details of Contact Person
Public Query  
Name  Adarsh Tekumalla 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education 
Address  105,Minerva Heights, Manipal, Udupi
Madhav nagar, Manipal
Udupi
KARNATAKA
576104
India 
Phone  8056170108  
Fax    
Email  tekumalla.adarsh@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dept of Orthopaedics 
Address  Kasturba Medical College, Madhav Nagar, Manipal 576104 
Type of Sponsor  Private medical college 
 
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 Adarsh Tekumalla  Kasturba Medical College  Dept of Orthpaedics (room No.4),Kasturba Medical College, Madhav Nagar, Manipal, Udupi
Udupi
KARNATAKA 		 8056170108

tekumalla.adarsh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M242||Disorder of ligament,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Clinico-radiologically proven cases of ACL tear (with/ without
concurrent meniscal injuries) treated by ACL reconstruction 
 
ExclusionCriteria 
Details  -Associated MCL grade 3 or LCL grade 2/ 3 injuries
-Associated PCL tear
-Bilateral ACL deficiencies
-Revision ACL procedures
-Intra articular distal femur fractures
-Associated tibial plateau fracture/ avulsion 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
-IKDC Subjective knee evaluation Score
-Modified Cincinnati Rating System Questionnaire
-Tegner Lysholm Knee Scale 		 All outcomes will be measured after a minimum of one year after surgical procedure 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   17/09/2021 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [tekumalla.adarsh@gmail.com].

  6. For how long will this data be available start date provided 30-11-2021 and end date provided 30-11-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

-Anterior cruciate ligament injuries are some of the commonest injuries of the knee joint requiring treatment.MRI plays an irreplaceable role in the diagnosis  and management of these injuries. 

-True anatomic femoral and tibial tunnel placements have been shown to be associated with fewer complications and better functional outcome.

-The aim of the study is to correlate the accuracy of anatomical tunnel placement during anterior cruciate ligament reconstruction with functional outcome.

-The objectives of this study are to ascertain the femoral and tibial tunnel orientation using MRI, to do functional evaluation 1 year after surgery & correlation between tunnel placement and functional outcome.

 


 
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