| CTRI Number |
CTRI/2026/01/101289 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
comparison of outcome between end-to-end suturing and flexor hallucis longus augmentation in tendo achilles rupture |
|
Scientific Title of Study
|
A comparative study of functional outcome between end-to-end suturing and flexor hallucis longus augmentation in tendo achilles rupture |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vineeth B Maligi |
| Designation |
postgraduate |
| Affiliation |
Vinayaka Mission Kirupananda Variyar Medical college and hospital |
| Address |
vinayaka mission kirupananda variyar medical college and hospital chinnaseeragapadi salem
Salem
TAMIL NADU
636308
India |
| Phone |
9148139844 |
| Fax |
|
| Email |
vineetbmaalgi183@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hari Sivanandan |
| Designation |
head of department orthopaedics |
| Affiliation |
Vinayaka Mission Kirupananda Variyar Medical college and hospital |
| Address |
vinayaka mission kirupananda variyar medical college and hospital chinnaseeragapadi salem
TAMIL NADU
636308
India |
| Phone |
9790449375 |
| Fax |
|
| Email |
sivadr1983@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vineeth B Maligi |
| Designation |
postgraduate |
| Affiliation |
Vinayaka Mission Kirupananda Variyar Medical college and hospital |
| Address |
vinayaka mission kirupananda variyar medical college and hospital chinnaseeragapadi salem
TAMIL NADU
636308
India |
| Phone |
9148139844 |
| Fax |
|
| Email |
vineetbmaalgi183@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vineeth B Maligi |
| Address |
vinayaka mission kirupananda variyar medical college and hospital chinnaseeragapadi salem |
| 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 |
| Vineeth B Maligi |
vinayaka mission kirupananda variyar medical college and hospitals |
department of orthopaedics vinayaka mission kirupananda variyar medical college and hospitals chinnaseeragapadi salem
Salem
TAMIL NADU |
9148139844
vineetbmaalgi183@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S860||Injury of Achilles tendon, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
end to end suturing |
proximal and distal ends of the ruptured achilles tendon are sutured together |
| Intervention |
flexor hallucis longus augmentation |
flexor tendon longus tendon is augmented into achilles tendon rupture site |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
tendoachilles rupture eligible for surgical repair
willingness to participate and comply with follow up |
|
| ExclusionCriteria |
| Details |
compound injuries
immunocompromised states
previous achilles tendon injuries
uncontrolled diabetes mellitus or vascular diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| flexor hallucis longus augmentation results in better functional outcome compared to end to end suturing in achilles tendon rupture cases. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| flexor hallucis longus augmentation results in better functional outcome compared to end to end suturing in achilles tendon rupture cases. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
23/01/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Achilles tendon rupture is one of the most common tendon injuries, particularly affecting active individuals, aged between 30 to 50 years. It causes significant morbidity impacting mobility, weight-bearing capacity and quality of life. This study aims to compare and evaluate the two techniques used in the treatment of the aforementioned: end-to-end suturing and flexor hallucis longus tendon augmentation and their functional outcomes, complication rates, and patient satisfaction. |