| CTRI Number |
CTRI/2021/06/034398 [Registered on: 25/06/2021] Trial Registered Prospectively |
| Last Modified On: |
17/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of HF-MFS and ASA grading for prediction of post-operative outcomes in hip fracture patients |
|
Scientific Title of Study
|
Comparison of diagnostic accuracy of Hip Fracture Multidimensional Frailty Score (HF-MFS) with American Society of Anesthesiologists (ASA) grading for prediction of post-operative outcomes in hip fracture patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aritra Goswami |
| Designation |
Postgraduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9041976426 |
| Fax |
|
| Email |
aritrag1297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
|
| Fax |
|
| Email |
swatirohitjindal604@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Jindal |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Orthopaedic Surgery, Block D, Level 3, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
|
| Fax |
|
| Email |
swatirohitjindal604@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, GMCH Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care GMCH Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32, Chandigarh |
| Type of Sponsor |
Government 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 Aritra Goswami |
Government Medical College and Hospital, Chandigarh |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
9041976426
aritrag1297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Comparator Agent |
American Society of Anesthesiologists (ASA) grading |
Classification of patients using ASA grading and comparison against HF-MFS score with regards to prediction of post-operative outcomes |
| Intervention |
Hip Fracture Multidimensional Frailty Score (HF-MFS) |
Classification of patients using HF-MFS preoperatively for comparison against ASA grading with regards to prediction of post-operative outcomes |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age ≥50 years
2. Patients with hip fractures (intra- and extra-capsular)
3. ASA Grade II-III patients
4. Patients posted for surgery between March 2021 and September 2022 |
|
| ExclusionCriteria |
| Details |
1. Age < 50 years
2. Non-hip fractures
3. Moribund patients or patients unfit for surgery (ASA Grade IV-V)
4. Patients managed conservatively
5. Patients who refused surgery or died before surgery
6. Patients with end-stage or active malignancy with metastasis; multiple fractures; polytrauma
7. Patients unable to be contacted for outcome evaluation |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the diagnostic accuracy of HF-MFS with ASA grading for prediction of post-operative outcomes. |
24 hours, 1 week, 1 month, 2 months and 3 months after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the diagnostic accuracy of HF-MFS with modified frailty index (mFI-11)
2. To determine if Hip-Fracture Multidimensional Frailty Score (HF-MFS) is able to predict post-operative mortality after hip surgery with 90 days after surgery. |
24 hours, 1 week, 1 month, 2 months and 3 months after surgery |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hip Fractures are one of the most common fractures seen in the age group 50-99 years, and cause significant morbidity and mortality, along with a high-risk of post-operative complications. These complications can include incomplete recovery due to age, permanent disability, post-operative infections, ICU admissions, re-operation risk, and mortality. In this study, patients will be studied pre-operatively using the HF-MFS system and ASA grading, to classify them on the basis of surgical risk and chances of occurrence of post-operative complications. This study will then aim to determine the predictive value of the multidimensional frailty score (HF-MFS), which uses a combination of clinical, anthropometric and laboratory parameters, as compared to ASA grading, to predict 90-day post-operative outcomes in patients undergoing hip surgeries in an Indian healthcare setting. |