FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/06/113079 [Registered on: 24/06/2026] Trial Registered Prospectively
Last Modified On: 24/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Post-operative Outcomes of Tunnel Orientation Versus post opeartive lysohlm and IKDC scores. 
Scientific Title of Study   Post operative outcomes of tunnel orientation in post operative ACL reconstruction patients - MRI based study 
Trial Acronym  Nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anurag Rayalla 
Designation  Junior resident  
Affiliation  Kasturba medical college, Manipal 
Address  Depatment of orthopaedics, KMC Manipal. Tiger circle road Madhav nagar Eshwar nagar Manipal Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9502037585  
Fax    
Email  anurag.rayalla07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Kiran K V Acharya  
Designation  Professor and Head of the department  
Affiliation  Kasturba medical college, Manipal 
Address  Depatment of orthopaedics, KMC Manipal. Tiger circle road Madhav nagar Eshwar nagar Manipal Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9343130539  
Fax    
Email  kiran.acharya@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Anurag Rayalla 
Designation  Junior resident  
Affiliation  Kasturba medical college, Manipal 
Address  Department of orthopaedics, KMC, Manipal Tiger circle road Madhav nagar Eshwar nagar Manipal Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9502037585  
Fax    
Email  anurag.rayalla07@gmail.com  
 
Source of Monetary or Material Support  
Kasturba medical college, Manipal 
 
Primary Sponsor  
Name  Kasturba medical college Manipal  
Address  Department of orthopaedics, Kasturba medical college, Tiger circle road, Madhav nagar, Manipal, karnataka 
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 Anurag Rayalla  Kasturba Hospital KMC, Manipal   Department of orthopaedics, KMC, Kasturba Medical College,Tiger Circle Road, Madhav Nagar,Manipal, Udupi District,Karnataka - 576104, India.
Udupi
KARNATAKA 
9502037585

anurag.rayalla07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Hospital Institutional Ethics Commitee- 2 (Student Research))  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 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient who underwent ACL reconstruction under department of orthopaedics, KMC Manipal 
 
ExclusionCriteria 
Details  Patients with multi-ligmentous injuries, fracture of bone, previously operated knee, congenital deformities, incomplete records 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Tunnel orientation vs post operative Lysholm score and IKDC scores at 6 weeks, 3 months and 6 months   Tunnel orientation vs post operative Lysholm score and IKDC scores at 6 weeks, 3 months and 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
Tunnel orientation versus Post operative knee ROM   Post operative 3 weeks, 3 months & 6 months 
 
Target Sample Size   Total Sample Size="57"
Sample Size from India="57" 
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)   06/07/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  06/07/2026 
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  

ACL reconstruction has evolved over the years into a more anatomical technique so as to replicate the original ACL origin and insertion. Tunnel position has taken preponderance in recent times as it has been identified as one of the most important aspect of the procedure that determines outcomes .Outcomes have been measured on the basis of patient-reported outcome measures, stability of the knee, and activity levels. Tunnel position has been found to be an important variable in these outcomes. Tunnel positions can be assessed via X-ray and computed tomography (CT) scan with CT being potentially more accurate as it gives a three-dimensional picture of the femoral and tibial tunnel apertures. There have been studies done in the past to assess femur and tibial tunnels positions in various techniques of doing ACL reconstructions. Femoral tunnel position has been shown to influence patient-reported outcomes more than the tibial tunnel position.  Tunnel malposition is an iatrogenic complication and studies have been done in the past which showed that when viewing the femoral footprint end on while drilling the femoral tunnel produced tunnels that were more anatomic, but it was not statistically significant.

The ultimate result of a surgery is measured by the patients return to activity and pre-operative functional levels that may be different for different individuals. However, instrumented objective methods can also be used to measure stability of individual ligaments. Studies in the past have shown that even though there may not be statistically significant differences in the objective arthrometric measurement before and after surgery, subjective scores do show a significant improvement 

The age and BMI of the patients did not seem to affect outcomes, as most of  the patients were of a similar age group and there were no obese patients in this subset. There was no statistically significant difference in the age and BMI of patients in the tunnel groups compared. Patients that had their operation within 3 months of their injury had better IKDC and hop test scores. This could be attributed to the fact that lesser injuries to surrounding structures or their capacity to heal are better when operated upon early. A chronic ACL deficient knee may lead to degenerative changes and injury to secondary stabilizers over a period of time worsening outcomes.Meniscus surgery did not seem to affect outcomes as in most cases, there was either no meniscus surgery or they were repaired, that to preserve the biomechanics of the knee. The minority of cases that had a partial meniscectomy was smaller in number and could be a possible reason for not influencing outcomes. Also, the follow-up was for 34 months, longer follow-up might be necessary to conclusively identify the role of meniscus surgery on outcomes. Studies in the past have used CT and X-rays to measure tunnel positions as well as outcome measures for stability and PROM’s post-ACL reconstruction.

The primary objective of my study is to assess post operative MRI findings with functional outcomes in patients undergoing arthroscopic ACL reconstruction


 
Close