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CTRI Number  CTRI/2024/09/074339 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Additional procedures with Anterior Cruciate Ligament Reconstruction in High Risk Patients: A Randomised Control Trial 
Scientific Title of Study   Lateral Extraarticular Tenodesis vs Anterolateral Ligament Reconstruction with Anterior Cruciate Ligament Reconstruction in High Risk Patients: A Randomised Control 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  Nirvin Paul 
Designation  Senior Resident 
Affiliation  AIIMS Rishikesh 
Address  Sports Injury Division, Department of Trauma Surgery and Critical care, AIIMS Rishikesh
Room 501, Senior Resident Hostel 85, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249201
India 
Phone  99254291  
Fax    
Email  drnirvinpaul@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof. Dr. Md Quamar Azam 
Designation  Professor and Head of the Department 
Affiliation  AIIMS Rishikesh 
Address  Sports Injury Division, Department of Trauma Surgery and Critical care, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249201
India 
Phone  99254291  
Fax    
Email  qazam47@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nirvin Paul 
Designation  Senior Resident 
Affiliation  AIIMS Rishikesh 
Address  Sports Injury Division, Department of Trauma Surgery and Critical care, AIIMS Rishikesh
Room 501, Senior Resident Hostel 85, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249201
India 
Phone  99254291  
Fax    
Email  drnirvinpaul@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Sports Injury Division 
Address  Department of Trauma Surgery and Critical Care, AIIMS Rishikesh, 249201 
Type of Sponsor  Government 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 Nirvin Paul  All India Institute of Medical Sciences, Rishikesh  Sports Injury Division, Department of Trauma surgery, All India Institute of Medical Sciences, Rishikesh 249201
Dehradun
UTTARANCHAL 		 9952542591

drnirvinpaul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS Rishikesh  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 
Comparator Agent  Anterolateral ligament reconstruction with Anterior cruciate ligament reconstruction  The Gracilis tendon is used to reconstruct the anterolateral ligament by fixing at a point midway between Gerdy tubercle and Fibular head on tibia and posteroinferior to lateral epicondyle on femur Patients will be followed up at 0, 3, 6, 9 and 12 months 
Intervention  Lateral Extraarticular tenodesis with Anterior cruciate ligament reconstruction  Using the modified Lemaire technique, a 7cm x 1 cm strip of Iliotibial band is harvested and passed deep to the lateral collateral ligament and fixed posteroinferior to the lateral epicondyle on the femur. Patients will be followed up at 0, 3, 6, 9 and 12 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients 
 
ExclusionCriteria 
Details  1. Posterolateral corner injury
2. Lateral compartment Osteoarthritis
3. Patients with prior fractures or surgeries around the knee
4. Skeletal Immaturity 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the clinical outcomes and functional outcome scores (Tegner-Lysholm Score) in the postoperative period vs preoperative period between the two groups  Baseline, 3 months, 6 months and final follow up at 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare functional outcomes in both groups using other outcome measures like KOOS score, and IKDC score at 3 and 6 months in high risk patients.
2. To correlate whether risk factors like Segond’s fracture, increased posterior tibial slope, Lateral femoral notch sign, and femoral contusion increase the risk of failure of ACLR and necessitate an extra-articular procedure.
3. To find the incidence of residual anterolateral instability, graft rupture rate, and donor site morbidity 		 3 and 6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/10/2024 
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="2"
Months="0"
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  
Patients who undergo Anterior cruciate ligament reconstruction have often been found to have residual Anterolateral rotatory instability. This is more common in patients who have high risk factors for graft failure (details in inclusion criteria mentioned above). Hence, these patients benefit from an extra articular procedure in addition to Anterior cruciate ligament reconstruction to reduce chance of graft failure and to improve clinical and functional outcomes. Both Lateral extra-articular tenodesis and Anterolateral ligament reconstruction have been advocated as the additional procedures.

In this thesis, we aspire to compare the clinical and functional outcomes of extra-articular procedures performed to minimize residual Anterolateral rotatory instability following Anterior cruciate ligament reconstruction. We will be comparing the outcomes of Lateral extra-articular tenodesis and Anterolateral ligament reconstruction in high risk patients. 

The hypothesis for the proposed study is that “Anterior cruciate ligament reconstruction + Anterolateral ligament reconstruction leads to better clinical and functional outcomes compared to Anterior cruciate ligament reconstruction +  Lateral extra-articular tenodesis”.
 
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