| CTRI Number |
CTRI/2025/04/083828 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mobile application OrthoSync] |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Manual versus Mobile App-Based Data Collection for Assessing Recovery in Patients with Severe Leg Bone Infections Treated with Ilizarov Fixation |
|
Scientific Title of Study
|
Evaluation of Effectiveness between Manual data collection and mobile
Application Based Data Collection for Infective non-union of long bone of Lower Limb Managed with Ilizarov Ring Fixation Using ASAMI 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 |
Obli Prakash PC |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital. |
| Address |
Department of Orthopedics , third floor, Saveetha medical college
and hospital, Poonamallee , Chennai, Kuthambakkam, Tamil Nadu
602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9159826850 |
| Fax |
|
| Email |
obli.pc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yeshwanth S |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Orthopedics , third floor, Saveetha medical college
and hospital, Poonamallee , Chennai, Kuthambakkam, Tamil Nadu
602105 ,India .
Chennai
TAMIL NADU
602105
India |
| Phone |
9840092819 |
| Fax |
|
| Email |
djyesh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yeshwanth S |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Orthopedics , third floor, Saveetha medical college
and hospital, Poonamallee , Chennai, Kuthambakkam, Tamil Nadu
602105 ,India .
Chennai
TAMIL NADU
602105
India |
| Phone |
9840092819 |
| Fax |
|
| Email |
djyesh@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| 2nd floor, Department of orthopaedics , Saveetha medical college and hospital, Kuthambakkam , Chennai , Tamil Nadu 602105 |
|
|
Primary Sponsor
|
| Name |
Obli Prakash P.C |
| Address |
2nd floor, Department of orthopaedics , Saveetha medical college and hospital, Kuthambakkam , Chennai , Tamil Nadu 602105 |
| 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 Obli Prakash PC |
Saveetha medical college and hospital |
Department of
Orthopedics , third floor,
Saveetha medical
college and hospital,
Poonamallee , Chennai,
Kuthambakkam, Tamil
Nadu 602105 ,India .
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
9159826850
obli.pc@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: M848||Other disorders of continuity of bone, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Manual data collection |
Patients undergoing illizarov ring fixation will follow conventional rehabilitational protocol without the use of mobile application ORTHOSYNC |
| Intervention |
ORTHOSYNC |
Patients undergoing ilizarov ring fixatation for infective non union of femur and tibia will use the mobile application called ORTHOSYNC part of their post operative protocol. The intervention that is patients undergoing rehabilitation 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. |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of surgicalable age who have extra-articular tibial or femoral infective non-union and who consent to treatment and follow-up. |
|
| ExclusionCriteria |
|
|
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 |
| The primary outcome is to evaluate the accuracy and efficiency of data collection for functional and radiological outcomes in patients with infective non-union of long bones treated with Ilizarov ring fixation. The study will compare mobile app-based data collection with the manual method using ASAMI scoring to assess data entry time, accuracy, and completeness, aiming to improve efficiency and reduce errors. |
The assessments will be conducted at 1 month, 3 months, 6 months, and 1 year post-intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes include several aspects. First, patient outcomes will be compared between the two groups based on functional recovery & radiological healing, assessed using the ASAMI scoring system over the 6-month study period. Second, user satisfaction among healthcare professionals regarding the ease of use & effectiveness of the mobile application versus manual methods will be assessed through a Likert scale-based feedback questionnaire at the end of the study. Third, data management metrics such as the time taken for data entry, retrieval, & analysis will be compared between the two methods using recorded time logs. Finally, the completeness of datasets & error rates in data collection will be evaluated by auditing both methods for missing or incorrect entries at the end of the study. These outcomes will provide a comprehensive understanding of the effectiveness & feasibility of mobile application-based data collection in clinical research. |
1 month,3 month,6 month,1 year |
|
|
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)
|
14/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/04/2025 |
| 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
|
This study aims to compare the effectiveness of manual data collection and mobile application-based data collection in assessing functional and radiological outcomes of infective non-union of long bones of the lower limb managed with Ilizarov ring fixation. The outcomes will be evaluated using the ASAMI (Association for the Study and Application of Methods of Ilizarov) scoring system. The primary objective is to determine the accuracy, efficiency, and completeness of data collected through both methods. Secondary objectives include assessing functional recovery, radiological healing, user satisfaction, time efficiency, and error rates in data collection. Patients will be followed up for 6 months, with data collected at baseline, 1 month, 3 months, and 6 months. The study aims to provide insights into the feasibility and advantages of mobile application-based data collection in clinical research
|