| CTRI Number |
CTRI/2025/03/083532 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Study |
| Study Design |
Other |
|
Public Title of Study
|
Machine Learning model to predict high risk individuals for ACL reinjury post reconstruction using Clinical Biomechanical and Demographic factors |
|
Scientific Title of Study
|
A Machine Learning Based Predictive model to identify individuals at high risk of Anterior Cruciate Ligament Reinjury after reconstruction based on Clinical, Biomechanical and Demographic factors: A Retrospective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Nilesh Surana |
| Designation |
Post Graduate |
| Affiliation |
Kasturba Medical College, Mangalore, MAHE |
| Address |
Department of Physiotherapy, Centre for Basic Sciences, Bejai, Kasturba Medical College, Mangalore - 575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
7708106751 |
| Fax |
|
| Email |
sneha.mchpmlr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sneha Nilesh Surana |
| Designation |
Post Graduate |
| Affiliation |
Kasturba Medical College, Mangalore, MAHE |
| Address |
Department of Physiotherapy, Centre for Basic Sciences, Bejai, Kasturba Medical College, Mangalore - 575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
7708106751 |
| Fax |
|
| Email |
sneha.mchpmlr2024@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish John Prabhakar |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore, MAHE |
| Address |
Department of Physiotherapy, Centre for Basic Sciences, Bejai, Kasturba Medical College, Mangalore - 575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8123223092 |
| Fax |
|
| Email |
ashish.john@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Mangalore, MAHE, Dakshina Kannada, Karnataka-575001, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Sneha Nilesh Surana |
Kasturba Medical College Hospital Jyothi |
Department of Physiotherapy, Fifth floor, Umbedkar Circle, Mangalore 575002
Dakshina Kannada
KARNATAKA |
7708106751
sneha.mchpmlr2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Control group
Patients who have undergone Primary ACL reconstruction and concomitant injury to medial/lateral meniscus and medial and lateral collateral ligament
Study Group
Patients who have undergone revision ACL reconstruction and concomitant injury to medial/lateral meniscus and medial/lateral collateral ligament |
|
| ExclusionCriteria |
| Details |
Patients with missing essential data
Patients with avulsion fracture
Road traffic Accident related ACL reconstruction surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Beightons score
2) MMT (Manual Muscle Testing) of quadriceps and hamstrings |
Baseline, following the injury and prior to the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "206"
Final Enrollment numbers achieved (India)="206" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/04/2025 |
| Date of Study Completion (India) |
31/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 title is A machine learning based predictive model to identify individuals at high risk of Anterior Cruciate Ligament Reinjury after reconstruction based on clinical, biomechanical and demographic factors: A retrospective study. The study aims to identify significant risk factors of Anterior Cruciate Ligament reinjury after reconstruction and to develop a predictive model using machine learning algorithm to identify individuals who are at high risk of reinjury. The data will be gathered from medical records who fulfil the inclusion and exclusion criteria. A variety of demographic, clinical and biomechanical data will be compiled and used to develop the machine learning model. The outcome measures will be Beighton’s score to assess ligament laxity and assessing muscle strength of quadriceps and hamstrings. The data will be subjected to statistical analysis. |