| CTRI Number |
CTRI/2025/09/094150 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparitive study of different surgical modalities in hip fracture |
|
Scientific Title of Study
|
A Comparative study between Dynamic Hip Screw (DHS) and Biplane Double Screw Fixation (BDSF) for Neck of Femur Fractures |
| Trial Acronym |
. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhanush Delish |
| Designation |
junior resident, department of orthopaedic |
| Affiliation |
SRM medical college and research centre |
| Address |
department of orthopaedic, SRM medical college and research insititute
chennai
TAMIL NADU
603203
india
department of orthopaedic, SRM medical college and research insititute
chennai
TAMIL NADU
603203
indi
Chennai
TAMIL NADU
603203
India |
| Phone |
9766618824 |
| Fax |
|
| Email |
dhanushdelish123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dilip Kumar |
| Designation |
professor and unit cheif, department of orthopaedic |
| Affiliation |
srm medical college and research centre, srm university |
| Address |
department of of orthopaedic, srm medical college and research institute
chennai
TAMIL NADU
603203
india
TA
department of of orthopaedic, srm medical college and research institute
chennai
TAMIL NADU
603203
india
Chennai
TAMIL NADU
603203
India |
| Phone |
9884460536 |
| Fax |
|
| Email |
dilipkun@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dhanush Delish |
| Designation |
junior resident, department of orthopaedics |
| Affiliation |
srm medical college and research centre, srm university |
| Address |
department of of orthopaedic, srm medical college and research institute
chennai
TAMIL NADU
603203
india
department of of orthopaedic, srm medical college and research institute
chennai
TAMIL NADU
603203
india
Chennai
TAMIL NADU
603203
India |
| Phone |
9766618824 |
| Fax |
|
| Email |
dhanushdelish123@gmail.com |
|
|
Source of Monetary or Material Support
|
| srm medical college and research institute, srm university, katankulathur, chengalpet,chennai,TAMIL NADU
603203, india |
|
|
Primary Sponsor
|
| Name |
Dhanush delish |
| Address |
Delshe Tower Lic Road, Talap
Civil station kannur
KANNUR, KERALA 670002
India |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| dhanush delish |
srm medical college hospital and research institute |
office, Department of orthopaedics, 2nd floor,srm medical college building, Katankulathur -603203,
Chengalpet district,
Chennai,
TAMIL NADU
Chennai
TAMIL NADU |
9766618824
dhanushdelish123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL INSTITUITIONAL ETHICS COMMITEE |
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 |
BIPLANE DOUBLE SUPPORTED SCREW FIXATION IN NECK OF FEMUR FRACTURE |
BDSF is a method that uses three screws placed in two different planes to fix femoral neck fractures. The screws are positioned to provide double cortical support, enhancing stability and reducing the risk of screw cut-out. This technique improves fracture compression and promotes better healing, especially in unstable fractures. It allows early weight-bearing and helps preserve the blood supply to the femoral head |
| Intervention |
DYNAMIC HIP SCREW FIXATION IN NECK OF FEMUR FRACTURE |
The Dynamic Hip Screw (DHS) is used to fix neck of femur fractures, especially intertrochanteric types. It involves inserting a lag screw into the femoral head, connected to a side plate fixed on the femoral shaft. The sliding mechanism allows controlled compression at the fracture site during weight bearing, promoting healing. This method provides stable fixation and enables early mobilization. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Patients diagnosed radiologically with femoral neck fractures
-Age group greater 20 and less than 60 years old
-Pauwels type 1 - 3
-Garden classification type 1 - 4
|
|
| ExclusionCriteria |
| Details |
-Patient with malignancy or any terminal illness.
-Old neck of femur fractures with avascular necrosis of femoral head or non union
-Any local hip pathology (ex: infection)
-Significant neurological illness
-Significant comorbidities
-Patients aged above 60 years
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Modified Harris hip score
-Nottingham hip fracture score
-VAS score
|
FIRST 6 MONTHS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Modified Harris hip score
-Nottingham hip fracture score
-VAS score |
1 YEAR TO 3 YEARS |
|
|
Target Sample Size
|
Total Sample Size="60"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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 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
|
•Multiple screw fixation is less invasive and more bone preserving. •DHS fixation is biomechanically more stable and hence used for more complex fracture patterns. •No available study to compare between BDSF and DHS in the treatment of femoral neck fractures. |