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CTRI Number  CTRI/2024/11/077433 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 01/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   "A Study on MRI and Hamstring Autograft Size for Improved Surgical Planning" 
Scientific Title of Study   Investigating the Magnetic Resonance Imaging Cross-section area that best correlates with intraoperative hamstring auto graft size. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anil Kumar Das 
Designation  Junior Resident Academic 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department Of Orthopaedics, Rajendra Institute Of Medical Sciences, Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  09097168290  
Fax    
Email  eni26k@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Govind Kumar Gupta 
Designation  Additional Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Orthopaedics, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand Rajendra Institute Of Medical Sciences Ranchi JHARKHAND 834009 India

Ranchi
JHARKHAND
834009
India 
Phone  7979014287  
Fax    
Email  gkgupta1975@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Govind Kumar Gupta 
Designation  Additional Professor  
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Orthopaedics, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand India

Ranchi
JHARKHAND
834009
India 
Phone  7979014287  
Fax    
Email  gkgupta1975@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Orthopaedics, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Postal Code 834009 Jharkhand India 
 
Primary Sponsor  
Name  Rajendra Institute of Medical Sciences 
Address  Department of Orthopaedics, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Postal Code 834009 Jharkhand India 
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 Anil Kumar Das  Rajendra Institute of Medical Sciences  Department Of Orthopaedics, A2,B1 and C2 Ward, Ground Floor Bariatu.
Ranchi
JHARKHAND 
09097168290

eni26k@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,RIMS,Ranchi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S835||Sprain of cruciate ligament of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Young Adults (20 – 45 yr).
2. Patients with chronic ACL Injury.
3. Patients with ACL injury associated with Meniscal Injuries.
 
 
ExclusionCriteria 
Details  1. Patients with acutely injured Knee.
2. Patients with history of previous Knee
surgeries.
3. Patients with infection of the Knee.
4. Patients with degenerative joint disease of the
Knee.
5. Patients with multi ligamentous knee instability.
6. Patients with stiff Knee with deformity.
7. Patients with associated metabolic disorders.
8. Patients with associated inflammatory disorders
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The primary objective of this study is to investigate the feasibility and accuracy of utilizing pre-operative MRI scans to predict the intraoperative hamstring graft size in patients undergoing anterior cruciate ligament (ACL) reconstruction surgery.  1 Year 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine the extent of correlation between specific pre-operative MRI measurements and the actual intraoperative hamstring graft size.
2.To develop a predictive model based on the pre-operative MRI data that can estimate the intraoperative hamstring graft size with a high level of accuracy.
 
1 Year 
 
Target Sample Size   Total Sample Size="41"
Sample Size from India="41" 
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)   01/12/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

The primary function of the ACL is to prevent anterior translation of the tibia relative to the femur. Other functions of the ACL include resisting internal rotation of the tibia and varus or valgus stress of the tibia in the presence of collateral ligament injury.Rupture of ACL is one of the most common  ligamentous injuries of the knee  with an incidence of 68.6 per 100,000 population. The incidence of reconstruction of the anterior cruciate ligament has been reported as high as 75,000–100,000 per year in the India. It is most commonly caused by sports injuries, however in India, it is mainly caused by road traffic accidents.

Anterior cruciate ligament (ACL) injury is very frequent, not only in professional athletes but also–increasingly often- in people who practice sports regularly. Conservative treatment usually fails to eliminate recurrent symptoms during the return to activities. Additionally, with subsequent instability episodes, patients may show an accelerated onset of degenerative joint changes and meniscal injuries. ACL reconstruction aims to eliminate symptoms and prevent such degenerative joint changes.ACL reconstruction restores the stability of the knee joint and protects the menisci and joint surfaces from further damage,6and prevents worsening of existing chondral lesions as well as occurrence of newer lesions. Reconstruction of the ACL may also alter the incidence of osteoarthritis in the longer term. Also, ACL does not have the potential to adequately heal by itself when torn, therefore surgical ACL reconstruction is generally the treatment of choice. Large variation in tendon size between individuals makes hamstring graft diameter for anterior cruciate ligament (ACL) reconstruction unpredictable. Inadequate graft diameter may necessitate an alternative source of tissue requiring pre-operative planning. The purpose of this study was to determine whether, magnetic resonance image (MRI) measurements and clinical anthropometric data are predictive of hamstring tendon graft diameter.

 
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