| CTRI Number |
CTRI/2025/07/090939 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to perform periodic evaluation of people having tendoachilles injury |
|
Scientific Title of Study
|
Outcome Analysis of Tendo-Achilles injuries in Adults: A cross sectional observational 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 |
Dr Nandagopal P |
| Designation |
Junior resident |
| Affiliation |
Kasturba medical college,manipal |
| Address |
Department of orthopaedics,
kasturba medical college
Manipal acdemy of higher education,Madhav nagar, manipal
Udupi
KARNATAKA
575119
India |
| Phone |
08848297227 |
| Fax |
|
| Email |
nandup97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnaprasad PR |
| Designation |
Associate professor |
| Affiliation |
Kasturba medical college,manipal |
| Address |
Department of orthopaedics,
Udupi
KARNATAKA
575119
India |
| Phone |
9845045970 |
| Fax |
|
| Email |
orthokrish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnaprasad PR |
| Designation |
Associate professor |
| Affiliation |
Kasturba medical college,manipal |
| Address |
Department of orthopaedics,
Udupi
KARNATAKA
575119
India |
| Phone |
9845045970 |
| Fax |
|
| Email |
orthokrish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of orthopaedics,KMC manipal,karnataka, India.PIN-576104 |
|
|
Primary Sponsor
|
| Name |
Department of orthopaedics |
| Address |
Kasturba medical college ,manipal,karnataka, India.PIN-576104 |
| Type of Sponsor |
Private 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 Nandagopal P |
Kasturba medicaal college,manipal |
Department of orthopaedics,
kasturba medical college
Udupi
KARNATAKA |
08848297227
nandup97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college,manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S96||Injury of muscle and tendon at ankle and foot level, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All cases of injury of tendo-achilles in adults attending department of Orthopaedics, KMC hospital will be included for the study |
|
| ExclusionCriteria |
| Details |
-Patients having associated neurovascular compromise of the ipsilateral limb.
-Patients with pre-existing neurological disorders of the ipsilateral limb
-Patients with pre-existing deformity/previous surgeries to the ipsilateral limb.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-To perform periodic (at baseline ,3 months and 6 months) clinical and functional evaluation of Tendo Achilles (TA) injuries with Patient Reported Outcome Measures (PROM), namely
-AOFAS hind foot scores
-Visual Analogue Score (VAS)
|
crossectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To compare the functional outcomes between patients who had undergone conservative management & surgical management at baseline,3 months & 6 months
|
crossectional study |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/07/2025 |
| 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="2"
Months="0"
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
|
-Study will include all patients with achilles tendon injury coming to ortho OPD
Questionare will be provided to the patients at their 3month,6month and 1 year followup and their clinical and functional outcomes are assesed on basis of that score |