| CTRI Number |
CTRI/2025/07/091343 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Quality of Life After 1 Year of Surgery for Hip Fractures Using a Questionnaire at Sri Ramakrishna Hospital operative management for proximal femur fractures– After 1 year in Sri Ramakrishna hospital |
|
Scientific Title of Study
|
Evaluation Of Quality of Life using EURO-5D5L Questionnaire for patients following surgically treated proximal femur fracture– After 1 year in Sri Ramakrishna hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sowndarya Kumar |
| Designation |
student (Master of Physiotherapy) |
| Affiliation |
Master of Physiotherapy in Orthopedics |
| Address |
Department of Orthopedics, physiotherapy department, Sri Ramakrishna College of physiotherapy, 395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
Coimbatore
TAMIL NADU
641012
India |
| Phone |
09384790501 |
| Fax |
|
| Email |
sowndaryakmr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K. Saravanan |
| Designation |
Professor |
| Affiliation |
Master of Physiotherapy in Orthopedics |
| Address |
Department of Orthopedics, physiotherapy department, Sri Ramakrishna College of physiotherapy, 395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9842124007 |
| Fax |
|
| Email |
Saro1978pt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sowndarya Kumar |
| Designation |
student (Master of Physiotherapy) |
| Affiliation |
Master of Physiotherapy in Orthopedics |
| Address |
Department of Orthopedics, physiotherapy department, Sri Ramakrishna College of physiotherapy, 395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
Coimbatore
TAMIL NADU
641012
India |
| Phone |
09384790501 |
| Fax |
|
| Email |
sowndaryakmr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
K.Sowndarya |
| Address |
395, Sarojini Naidu Road, Sidhapudur, Coimbatore- 641044 |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 Sowndarya Kumar |
Sri Ramakrishna Multispeciality Hospital |
Department of Orthopedics, physiotherapy department, Sri Ramakrishna Multispeciality hospital
, 395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
Coimbatore
TAMIL NADU |
09384790501
sowndaryakmr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramakrishna Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age group from 60 to 75 years of age.
Both male and female.
Patient who completed 1 year after the surgical intervention of proximal femur fracture
Patients who are co-operative/ Willing to participate
Patients who are available for around 30kms surrounding Sri Ramakrishna Hospital after discharge.
Those without linguistic barriers that would prohibit them from understanding the questionnaires
Minimum education level of 4th grade of elementary education |
|
| ExclusionCriteria |
| Details |
Participation in another surgical intervention or drug study during the study period.
Patients completed surgery more than 1 year 6 months of duration
Known metastatic disease.
Duration between fracture and admission to the hospital being more than three days.
Bilateral proximal femoral fractures.
Surgery delayed for any medical reasons. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Euro quality of life 5D 5L |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EuroQol 5D 5L |
baseline |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
30/07/2025 |
| 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="0"
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
|
The cross sectional study
was to be conducted on patients, who met the inclusion criteria after acquiring the approval of the
institutional committee and the approval from MD and Orthopedic surgeon. The data must be
collected from the Medical Record Department for patients sustaining
Intertrochanteric fractures. All consecutive patients from Jan 2024 to Jan 2025 at Sri Ramakrishna
Hospital with radiologically confirmed Proximal femur fracture of cases aging
from 60 to 75 years regardless of gender. An expert orthopedic
hip surgeon determined the type of fracture according to AO OTA classification
of proximal femur fracture. Data were collected
from medical records of the patients as well as in person interview of the
patient and their relatives. Patient’s data before and after surgery from post operative
day 1 demographic data, past medical history and information
pertaining to the surgery and type of fracture will be documented. And after completion
of 1 year from the month of surgery. Study procedure is
explained to the patient. The informed consent
must be obtained from the patients. EQ 5D 5L
questionnaire must be carried out by a written consent from the patients and
families. |