| CTRI Number |
CTRI/2025/02/080721 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mobile application”ORTHOFLEX HIP”] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Smart App for Faster Healing after hip surgery in elderly population |
|
Scientific Title of Study
|
EVALUATION OF EFFECTIVENESS OF MOBILE BASED APPLICATION VERSUS CONVENTIONAL REHABILITATION FOR THE RADIOLOGICAL AND FUNCTIONAL OUTCOME OF POST SURGICAL MANAGEMENT OF HIP FRACTURES IN GERIATRIC PATIENTS |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sajith S |
| 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 ,India
Chennai
TAMIL NADU
602105
India |
| Phone |
9946560805 |
| Fax |
|
| Email |
sajithssylus16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Benjamin vinodh J |
| Designation |
Associate 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 |
9445711147 |
| Fax |
|
| Email |
Benjaminvinodh91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Benjamin vinodh J |
| Designation |
Associate 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 |
9445711147 |
| Fax |
|
| Email |
Benjaminvinodh91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital, Poonamallee,Chennai,Kuthambakkam, Tamilnadu 602105 ,India . |
|
|
Primary Sponsor
|
| Name |
Sajith S |
| 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 SAJITH S |
Saveetha medical college and hospital Institutional Ethics Committe |
Department of Orthopedics , third floor, Saveetha medical college and hospital, Poonamallee , Chennai, Kuthambakkam, Tamil Nadu 602105 ,India . Chennai
TAMIL NADU
Chennai
TAMIL NADU |
996560805
sajithssylus16@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: S720||Fracture of head and neck of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile Application “ ORTHOFLEX HIP” |
Patients undergoing hip surgeries will use the mobile application "ORTHOFLEX HIP" as part of their post-operative rehabilitation protocol. 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 after surgery. The app aims to enhance patient engagement, adherence to rehabilitation exercises, and overall recovery |
| Comparator Agent |
Standard Post-Operative Care
|
Patients undergoing Hip surgeries will follow the standard post-operative care and rehabilitation protocol prescribed by the healthcare providers. This typically includes physiotherapy, home exercises, and follow-up visits but excludes the use of any mobile application or technology-based support for recovery. The comparator group serves as the control to evaluate the outcomes of the standard care process without the integration of the "ORTHOFLEX HIP" app. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1. Confirmed hip Surgery: Participants must have undergone surgical procedure for hip ( such as hemiarthroplasty, THR, proximal femur nailing)
2. Age Range: Participants aged more than 50 years and older are eligible for inclusion.
3. Time Since Surgery: Participants should be within a specified timeframe post-surgery, typically within the initial stages of rehabilitation (e.g., within the first 12 weeks post-surgery).
4. Functional Status: Participants should have a baseline level of functional mobility and independence, as determined by the treating physician or healthcare provider.
5. Ability to Understand and Follow Instructions: Participants must possess the cognitive ability to understand and follow the instructions provided as part of the rehabilitation program.
6. Consent: Participants must provide informed consent to participate in the rehabilitation program and any associated
|
|
| ExclusionCriteria |
| Details |
1) Previous hip Surgery: Participants who have undergone previous hip surgery on the same limb are excluded from participation.
2) Severe Comorbidities: Participants with severe comorbidities or medical conditions that may interfere with rehabilitation or increase the risk of complications are excluded.
3) Uncontrolled Medical Conditions: Participants with uncontrolled medical conditions, such as uncontrolled hypertension or diabetes, that may pose a risk during rehabilitation are excluded.
4) History of Adverse Reactions to Rehabilitation Interventions: Participants with a history of adverse reactions or complications related to previous rehabilitation interventions are excluded. |
|
|
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 hip function, range of motion, strength, and mobility, as measured by validated clinical scales over the study period. |
At 12 weeks post surgery |
|
|
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. |
3 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)
|
27/02/2025 |
| 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 for post-operative rehabilitation after hip surgery aims to enhance the recovery process and outcomes for patients undergoing this procedure. Through a user-friendly platform, the app guides patients through their rehabilitation exercises, tracks their progress, and educates them about the post-operative recovery journey. Furthermore, it fosters communication between patients and healthcare providers, facilitating timely support and guidance. Overall, the app seeks to improve patient engagement and adherence to rehabilitation protocols, ultimately leading to better recovery outcomes and overall satisfaction with the treatment process |