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CTRI Number  CTRI/2024/12/078156 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 13/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Position of tibial interference screw and graft position in tibial tunnel will be measured in patients undergoing Acl reconstruction and will be correlated to the functional outcome of knee  
Scientific Title of Study   Correlation between position of interference screw in tibial tunnel to its anatomical orientation and functional outcome in single bundle Acl reconstruction  
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 Mani Kislay Kumar  
Designation  Postgraduate student  
Affiliation  Rajendra institute of Medical Sciences Ranchi 
Address  Department of Orthopaedics Rajendra institute of Medical Sciences Bariatu Ranchi Jharkhand

Ranchi
JHARKHAND
834009
India 
Phone  7760008254  
Fax    
Email  idrmani9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Govind Kumar Gupta  
Designation  Additional Professor & HOD Orthopaedics  
Affiliation  Rajendra institute of Medical Sciences Ranchi 
Address  Department of Orthopaedics Rajendra institute of Medical Sciences Bariatu Ranchi Jharkhand

Ranchi
JHARKHAND
834009
India 
Phone  8235068192  
Fax    
Email  gkgupta1975@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Govind Kumar Gupta  
Designation  Additional Professor & HOD Orthopaedics  
Affiliation  Rajendra institute of Medical Sciences Ranchi 
Address  Department of Orthopaedics Rajendra institute of Medical Sciences Bariatu Ranchi Jharkhand

Ranchi
JHARKHAND
834009
India 
Phone  8235068192  
Fax    
Email  gkgupta1975@yahoo.co.in  
 
Source of Monetary or Material Support  
Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India. Pin code-834009 
 
Primary Sponsor  
Name  Rajendra Institute Of Medical Sciences 
Address  Department of Orthopaedics, Rajendra Institute of Medical Sciences, Bariatu ,Ranchi, Jharkhand-834009 
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 Mani Kislay Kumar  RAJENDRA INSTITUTE OF MEDICAL SCIENCES  OPD Room No 1,Department of Orthopaedics, Bariatu
Ranchi
JHARKHAND 		 7760008254

idrmani9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee 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 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1) Patients with isolated ACL injury who will undergo ACL reconstruction surgery using quadrupled hamstrings graft,

2) Patients willing to give consent and participate in the study.

3) No history of trauma in the post-operative or rehabilitation period. 
 
ExclusionCriteria 
Details  1) Patients with concomitant bony or other ligament injury to the same knee,

2) History of previous surgery to the same knee,

3) Revision ACL reconstruction surgery,

4) Patient not willing to participate in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate correlation between various positions of interference screw in tibial tunnel to the functional outcome of knee in single bundle ACL reconstruction  Functional outcome of knee will be assessed periodically using IKDC score, Lysholm score and Tegner score at

6weeks
3 month
6 month 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of screw position/orientation on patient’s satisfaction with the surgical outcome and their ability to return to pre-injury sports or activities  6weeks,3mon,6mon 
To investigate the effect of tunnel convergence on screw position/orientation and its implications for graft stability and functional outcomes.  6weeks,3mon,6mon 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   24/12/2024 
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)   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 study aims to evaluate correlation between position of interference screw in tibial tunnel to its anatomical orientation and functional outcome in single bundle ACL reconstruction. Pateints of both genders aged between 16-50 yrs with isolated acl injury will be enrolled into the study.Diagnosis is made by taking proper history followed by correlating clinical and radiological tests. Preoperative assessment is done by recording anthropometric parameters like age ,sex, BMI,functionalscores etc. All surgeries performed by experienced orthopedic surgeons using a standardized arthroscopic technique for single-bundle ACL reconstruction. Tibial tunnel drilling performed using anatomic landmarks or navigation systems to ensure consistency. Interference screw fixation of the graft in the tibial tunnel performed according to the surgeon’s preference within recommended guidelines. Postoperative Follow-up done by a)Clinical assessments at regular intervals (e.g., 6 weeks, 3 months, 6 months) b)Functional outcome measures: IKDC, Lysholm, Tegner scores c)Radiological assessment: MRI or CT scans to evaluate the position of the interference screw within the tibial tunnel. Data will be obtained and Correlation analysis (e.g., Pearson correlation coefficient) to assess the relationship between interference screw position in the tibial tunnel and functional outcome scores will be done. 
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