| CTRI Number |
CTRI/2026/04/108476 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using a Mobile App to Measure Tendon Size Before Knee Ligament (ACL) Surgery |
|
Scientific Title of Study
|
App to Preoperatively Measure Hamstring Tendon Length and Thickness in Patients Planned for Arthroscopic ACL Repair |
| 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 TALAL HASAN JUMIRUL HUSSAIN |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College And Hospital |
| Address |
Department Of Orthopaedics, Saveetha Medical College And Hospital, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
8778205383 |
| Fax |
|
| Email |
TALALHASAN45420@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIJAYAN B |
| Designation |
PROFESSOR |
| Affiliation |
Saveetha Medical College And Hospital |
| Address |
Department Of Orthopaedics, Saveetha Medical College And Hospital, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9884587223 |
| Fax |
|
| Email |
DOCVIJAYAN@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR TALAL HASAN JUMIRUL HUSSAIN |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College And Hospital |
| Address |
Department Of Orthopaedics, Saveetha Medical College And Hospital, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
8778205383 |
| Fax |
|
| Email |
TALALHASAN45420@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College And Hospital, Thandalam, Chennai- 602105 |
|
|
Primary Sponsor
|
| Name |
DR TALAL HASAN JUMIRUL HUSSAIN |
| Address |
Department Of Orthopaedics, Saveetha Medical College And Hospital, Thandalam, Chennai |
| Type of Sponsor |
Other [Self] |
|
|
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 TALAL HASAN JUMIRUL HUSSAIN |
Saveetha Medical College and Hospital |
Department of Orthopaedics,
Saveetha Medical College and Hospital,
Saveetha Nagar, Thandalam, Chennai – 602105
Kancheepuram
TAMIL NADU |
8778205383
TALALHASAN45420@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAVEETHA MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with anterior cruciate ligament (ACL) tear planned for primary arthroscopic ACL reconstruction using hamstring tendon autograft.
Patients with preoperative MRI of the affected knee available for measurement of hamstring tendon parameters.
Patients willing to provide written informed consent for participation in the study.
Patients with intact hamstring tendons and no prior ligament reconstruction in the affected knee. |
|
| ExclusionCriteria |
| Details |
Patients undergoing revision ACL reconstruction or with history of previous ACL surgery.
Patients with multiligament knee injury or associated major knee pathology.
Patients with congenital or acquired musculoskeletal deformity affecting lower limb.
Patients with inadequate / poor-quality MRI or MRI not available.
Patients with contraindication to MRI.
Patients unwilling to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of app-predicted vs intraoperative hamstring graft size |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between app-predicted graft size & intraoperative measured graft size (Pearson correlation coefficient). |
1 week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
24/04/2026 |
| 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="0"
Months="5"
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
|
Anterior cruciate ligament (ACL) reconstruction using hamstring tendon autograft requires adequate graft length and diameter for optimal surgical outcomes. Intraoperative measurement of graft size may lead to uncertainty and need for alternative graft options. This study aims to develop and validate a mobile application that predicts hamstring tendon length and diameter preoperatively using MRI-based and/or anthropometric parameters. Patients undergoing primary arthroscopic ACL reconstruction will be prospectively enrolled. Preoperative graft size predicted by the mobile application will be compared with actual intraoperative graft measurements. The study intends to evaluate the accuracy, correlation, and clinical utility of the application in predicting graft adequacy, thereby improving preoperative planning and reducing intraoperative uncertainty. |