| 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
|
|
|
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
|
|
|
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
|
|
|
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. |