| CTRI Number |
CTRI/2025/02/080079 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Mobile app to help treat patients undergoing hybrid external fixation for proximal tibia fractures |
|
Scientific Title of Study
|
Comparision of efficacy between Manual data collection Vs mobile based application data collection for functional and radiological outcome following Hybrid external fixation for complex proximal tibia fractures using Rasmussens Scoring System |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Tarunprasad |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Orthopaedics
Saveetha Medical College and Hospital, Chennai, 602105
, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
09962813183 |
| Fax |
|
| Email |
rtarunprasad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yeshwanth Subash |
| Designation |
Proffessor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Orthopaedics
Saveetha Medical College and Hospital, Chennai, 602105
, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9840092819 |
| Fax |
|
| Email |
djyesh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yeshwanth Subash |
| Designation |
Proffessor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Orthopaedics
Saveetha Medical College and Hospital, Chennai, 602105
, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9840092819 |
| Fax |
|
| Email |
djyesh@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital,Poonamallee,Chennai,Kuthambakkam, Tamilnadu
602105 ,India
|
|
|
Primary Sponsor
|
| Name |
R Tarunprasad |
| Address |
Saveetha medical college and hospital,
Poonamallee,Chennai,Kuthambakkam, Tamilnadu 602105 ,India . |
| 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 R Tarunprasad |
Saveetha Medical College and Hospital |
Department of
Orthopedics , third floor,
Saveetha medical
college and hospital,
Poonamallee , Chennai,
Kuthambakkam, Tamil
Nadu 602105 ,India .
Chennai Tamilnadu.
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
9962813183
rtarunprasad@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FOLLOW FIX |
Patients undergoing hybrid external fixation for proximal tibia fracture will use the mobile application called FOLLOW FIX s part of their post operative protocol.The intervention that is patients undergoing rehabilitatioanl programme will be for usual post operative period- from 6 months to one year. The app provides structured
guidance for recovery, including
tailored exercise programs,
reminders, progress tracking,
and educational content to
improve functional outcomes
and activities of daily living. The app aims to enhance patient engagement, adherence to rehabilitation exercises, and overall recovery. |
| Comparator Agent |
Manual data collection |
Patients undergoing hybrid external fixation will follow conventional rehabilitational protocol without the use of mobile application Follow Fix |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)All skeletally mature patients with Complex proximal tibia fractures who are willing for surgery and consenting for follow up.
2)Schatzker type 4, 5, 6.
3) Severely communited proximal tibia extra articular metaphyseal fractures.
4) Compound fractures ( Gustilo Anderson 2,3)
5) Tscherne Type 1,2,3.
6) Fracture with compartment syndrome following fasciotomy.
|
|
| ExclusionCriteria |
| Details |
Patients not willing for surgery and not consenting for follow up.
Patients with Schatzker Type 1 ,2, 3 fracture.
Patients with Gustilo Anderson grade 1.
Patients with Tscherne Grade 4.
Patients with immature skeletal system, pathological fractures, floating knee, Ipsilateral lower limb fractures.
Patients with polytrauma requiring prolonged ICU care.
Patients with active infection.
Patient with neurovascular injury, paralytic disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Enhanced functional recovery, including improvements in knee function, range of
motion, strength, and mobility, as measured by
validated clinical scales over the study period. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improved rehabilitation adherence rates
assessed through engagement metrics in the
mobile application.
Increased patient satisfaction evaluated via
standardized satisfaction surveys.
Reduction in healthcare utilization, including
fewer in-person visits and lower medical costs |
12 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)
|
15/02/2025 |
| 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 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
|
The
mobile application serves as a centralized platform for healthcare
professionals to compile, monitor, and manage patient data throughout the
course of treatment for complex proximal tibia fractures undergoing Hybrid
external fixation. It aims to enhance communication between healthcare
providers and patients while optimizing the efficiency of care delivery. |