FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090141 [Registered on: 03/07/2025] Trial Registered Prospectively
Last Modified On: 25/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   a set of questions will be created and tested to find out if people in India who are not athletes, and who had surgery to fix a torn knee ligament (ACL), were able to get back to their normal activities like they did before their injury. 
Scientific Title of Study   Development and validation of a questionnaire to evaluate the return to preinjury level in non-athletic individuals following Anterior Cruciate Ligament Reconstruction among Indian population 
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 Shubhra Mandal 
Designation  Junior Resident , Department of orthopaedics 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research,Pondicherry 
Address  Address No. T1, 3r Floor, Saffron Apartment, The Broad St, Delarshpet, Thilaspet, Kathirkamam, Puducherry, India

Pondicherry
PONDICHERRY
605009
India 
Phone  916340300  
Fax    
Email  shmandalsarmundo@outlook.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. GOPISANKAR @ BALAJI. G 
Designation  Proffessor , Department of orthopaedics 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research,Pondicherry 
Address  Department of orthopaedics, JIPMER,Jipmer Campus Rd, Dhanvantari Nagar, Puducherry, 605006, India

Pondicherry
PONDICHERRY
605009
India 
Phone  9360330582  
Fax    
Email  drgopi9596@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shubhra Mandal 
Designation  Junior Resident , Department of orthopaedics 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research,Pondicherry 
Address  Address No. T1, 3r Floor, Saffron Apartment, The Broad St, Delarshpet, Thilaspet, Kathirkamam, Puducherry, India

Pondicherry
PONDICHERRY
605009
India 
Phone  916340300  
Fax    
Email  shmandalsarmundo@outlook.com  
 
Source of Monetary or Material Support  
Research Section,Jawaharlal Institute of Postgraduate Medical Education and Research,PONDICHERRY, Jipmer Campus Rd, Dhanvantari Nagar, Puducherry, 605006, India  
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research, pondicherry 
Address  JIPMER Campus Road, Gorimedu, Dhanvantari Nagar, Puducherry – 605006, 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 Shubhra Mandal  old OPD block , Room 64,DEPARTMENT OF ORTHOPAEDICS , JIPMER  JIPMER Campus Road, Gorimedu, Dhanvantari Nagar, Puducherry - 605006, India.
Pondicherry
PONDICHERRY 
916304300

shmandalsarmundo@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES  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  40.00 Year(s)
Gender  Both 
Details  Non-athletic individuals between 18-40 years who
underwent ACL- reconstruction and completed at least 1year follow-up 
 
ExclusionCriteria 
Details  1.Patient with associated PCL injury
2. Associated grade 3 collateral injury
3. Individuals with coexisting other Musculo skeletal or other
neurological problems in the lower limb 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A new questionnaire will be developed to study the return to pre-injury levels in postoperative Anterior Cruciate Ligament patients in the Indian
population.

the developed questionarre will be validated against preexisting questionares 
9 month to 12 month post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
nil   
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   15/07/2025 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 help develop and validate a new questionnaire to evaluate the return to pre-injury level in non-athletes following ACL reconstruction surgery. The study is indicated for the reason that, despite having numerous scales and scoring systems to study return to sports, none of the questionnaires shed any light on non-sports-related activities of daily living or occupational activities. Most studies are inspired by and benefit high-demand patients (sportspersons).

Moreover, cultural and social factors greatly influence the recovery of patients and also affect activities of daily living (ADLs). Indian patients, who are in the habit of sitting cross-legged and squatting, will be fearful to do so post-operatively, but these factors are not taken into account in the pre-existing questionnaires.

After IEC approval, the study will proceed with expert validation involving approximately 10 orthopedicians, physiatrists, and physiotherapists, who will assess the questionnaire items for representativeness, clarity, relevance, and distribution using established quantitative indices, such as the Content Validity Ratio and Content Validity Index. Following this, cognitive interviews with approximately 10 participants will be conducted to ensure that the items are interpreted as intended and to validate the response process. The refined questionnaire will then be pilot tested with 75 patients, each at least one year post-ACL reconstruction, to evaluate its practicality and gather user feedback. Finally, data from the pilot will undergo exploratory and confirmatory factor analyses to determine the questionnaire’s structural validity, and reliability will be assessed using Cronbach’s alpha to ensure internal consistency of the scale.

 
Close