| CTRI Number |
CTRI/2024/08/072029 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Femoral Neck System or Cannulated Cancellous Screws which is better for management of intracapsular neck femur fracture |
|
Scientific Title of Study
|
Efficacy of Functional Outcome Of Femoral Neck System (FNS) and Cannulated Cancellous Screws(CCS)in the fixation of Intracapsular Fracture Neck of Femur -A Randomised controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanmay Khurana |
| Designation |
Junior resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences , Saifai , Etawah |
| Address |
Department of Orthopaedics
Uttar Pradesh University of Medical Sciences, Saifai,Etawah
Saifai,Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8750893834 |
| Fax |
|
| Email |
tanmaykhurana3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S.P.S. Gill |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences , Saifai , Etawah |
| Address |
Department of Orthopaedics
Uttar Pradesh University of Medical Sciences Saifai Etawah
Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9219699590 |
| Fax |
|
| Email |
simmygill@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanmay Khurana |
| Designation |
Junior resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences , Saifai , Etawah |
| Address |
Department of Orthopaedics
Uttar Pradesh University of Medical Sciences , SAIFAI ETAWAH
Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8750893834 |
| Fax |
|
| Email |
tanmaykhurana3@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
TANMAY KHURANA |
| Address |
Uttar Pradesh University of Medical Sciences Saifai Etawah UP India 206130 |
| 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 |
| TANMAY KHURANA |
UPUMS SAIFAI |
UPUMS , SAIFAI ETAWAH
Etawah
UTTAR PRADESH |
8750893834
tanmaykhurana3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International research committee and institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M955||Acquired deformity of pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
femoral neck system and cc screw |
Compare efficacy of the two implants femoral neck system and CC Screw for neck of femur fractures
TIME DURATION 18 Months |
| Intervention |
fns vs cc screw implant |
Compare efficacy of the two implants femoral neck system and CC Screw for neck of femur fractures
Time duration 18 Months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients in age groups 18-60 years ( Both sex )
Fracture duration less than 7 days
- Unilateral and Bilateral fracture of the neck of femur, and
|
|
| ExclusionCriteria |
| Details |
Pathological femoral neck fractures,
Open fractures
Fractures associated with femoral shaft
Fractures associated with Hip Dysfunction / Arthritis / Old Dislocations / Dysplastic Hip
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Femoral neck system implant |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare outcome of Femoral neck system and cc screw for fixation of neck of femur fractures |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [tanmaykhurana3@gmail.com].
- For how long will this data be available start date provided 18-06-2023 and end date provided 01-12-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Patients will be subjected to FNS vs CC Screw for the treatment of fracture neck femur and compare the outcome of the two implants |