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CTRI Number  CTRI/2024/02/062499 [Registered on: 09/02/2024] Trial Registered Prospectively
Last Modified On: 02/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Can semitendinosus alone be used in ACL reconstruction? 
Scientific Title of Study   A cross sectional study to determine usable semitendinosus tendon length in a cohort of patients undergoing anterior cruciate ligament reconstruction with hamstrings graft  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nirmal Sanjaykumar Rathi 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences,Raipur 
Address  D-306,Resident Hostel,AIIMS Campus,Tatibandh,Raipur, Chhattisgarh-492099

Raipur
CHHATTISGARH
492099
India 
Phone  07387626955  
Fax    
Email  nirmalrathi7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Sandeep Kumar Neema  
Designation  Professor 
Affiliation  All India Institute of Medical Sciences,Raipur 
Address  Department of Orthopaedics, D-block ground floor, All India Institute of Medical Sciences,Tatibandh,Raipur, Chhattisgarh-492099

Raipur
CHHATTISGARH
492099
India 
Phone  8940162132  
Fax    
Email  drsandeepnema@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nirmal Sanjaykumar Rathi 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences,Raipur 
Address  D-306,Resident Hostel,AIIMS Campus,Tatibandh,Raipur, Chhattisgarh-492099

Raipur
CHHATTISGARH
492099
India 
Phone  07387626955  
Fax    
Email  nirmalrathi7@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences,Raipur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences,Raipur 
Address  All India Institute of Medical Sciences,Tatibandh,Raipur, Chhattisgarh-492099 
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 Nirmal Sanjaykumar Rathi  AIIMS Raipur  Department of Orthopaedics,D-block Ground Floor,All India Institute of Medical Sciences,Tatibandh,Raipur, Chhattisgarh-492099
Raipur
CHHATTISGARH 
07387626955

nirmalrathi7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences, Raipur (Chhattisgarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  MRI confirmed anterior cruciate ligament tears in adults undergoing ACL reconstruction will be included in the study 
 
ExclusionCriteria 
Details  Patients of knee injury where other graft options are used for ACL Recpnstruction 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
We expect that the usable length and diameter of the quadrupled semitendinosus tendon will be more than 600mm and 8 mm after resection of flat terminal portion and muscle belly and keeping the cross-sectional diameter with circular or oval  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
not appliocable  not applicable 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   13/02/2024 
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 Yet Recruiting 
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 anterior cruciate ligament (ACL) is one of a pair of cruciate ligaments (the other being the posterior cruciate ligament) in the human knee.The purpose of the ACL is to resist the motions of anterior tibial translation and internal tibial rotation; this is important to have rotational stability. This function prevents anterior tibial subluxation of the lateral and medial tibiofemoral joints. The ACL has mechanoreceptors that detect changes in direction of movement, position of the knee joint, and changes in acceleration, speed, and tension. A key factor in instability after ACL injuries is having altered neuromuscular function secondary to diminished somatosensory information. For athletes who participate in sports involving cutting, jumping, and rapid deceleration, the knee must be stable in terminal extension.The ACL can be injured or torn in a number of different ways. The most common mechanism is that of a sudden pivoting or cutting maneuver during sporting activity, which is commonly seen in football, basketball and soccer. The ligament can also tear due to work injuries or automobile accidents.At the time of the injury, a “pop” or “snap” can sometimes be felt or heard. The amount of pain experienced at the time of the injury is somewhat variable but can be quite severe. Typically, the person is unable to continue play or activity, and has the impression that a significant injury has occurred.

During ACL reconstruction surgery, a graft is used to replace the torn ACL. One option for the graft is to use the hamstring tendons, specifically the semitendinosus and gracilis tendons, which are located at the back of the thigh. These tendons are often selected due to their accessibility, strength, and potential for successful incorporation into the knee joint.The surgical procedure involves harvesting the hamstring tendons, usually through a small incision near the knee. The tendons are then prepared by removing any excess tissue and folded over to create a stronger graft. The graft is then inserted into the knee joint, passing through tunnels drilled in the tibia and femur, to mimic the function of the original ACL.

Graft strength is only one of the factors influencing anterior cruciate ligament (ACL) graft choice.However, it has a direct bearing on ultimate stability,which is the goal of ACL.Load to failure (LTF) is the parameter used to compare strenghth of graft.10-mm BPTB graft would be 110% as strong as the native ACL. A two-strand semitendinosus (ST) and two-strand gracilis (Gr) (2ST/2Gr)graft would be 238% as strong as the native ACL.A four-strand ST (4ST) would be 280% as strong as the ACL.Four-strand hamstring autografts are the strongest available grafts,followed by tibialis, QT, and BPTB grafts, with insufficient data to evaluate Tendo Achilles grafts. All have greater strength than the native ACL.Graft strength is only one of many factors contributing to knee stability after ACL reconstruction.grafts retain only about half their initial strength at long-term follow-up. Thus, grafts that are significantly stronger than the native ACL at time zero may indeed be necessary to produce ultimate strengths that are as strong as the ACL initially was.Allografts are increasing rapidly in populari 

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