| CTRI Number |
CTRI/2024/01/061617 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of Proximal Femoral Nail A vs Proximal Femoral Nail A2 in Intertrochanteric femur fractures. |
|
Scientific Title of Study
|
Comparative study of proximal femoral nail A vs Proximal femoral nail A2 in intertrochanteric 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 |
Kevin Kawde |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi Meghe , Wardha |
| Address |
Department of Orthopedics, Jawaharlal Nehru Medical College, Sawangi Meghe , Wardha
Wardha
MAHARASHTRA
442001
India
Department of Orthopaedics,Jawaharlal Nehru Medical College, Sawangi Meghe , Wardha
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7999309155 |
| Fax |
|
| Email |
kevinkawde26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gajanan Pisulkar |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi Meghe , Wardha |
| Address |
Department of Orthopedics, Jawaharlal Nehru Medical College, Sawangi Meghe , Wardha
Wardha
MAHARASHTRA
442001
India
Department of Orthopaedics,Jawaharlal Nehru Medical College, Sawangi Meghe , Wardha
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822235475 |
| Fax |
|
| Email |
glpworld1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kevin Kawde |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi Meghe , Wardha |
| Address |
Department of Orthopedics, Jawaharlal Nehru Medical College, Sawangi Meghe , Wardha
Wardha
MAHARASHTRA
442001
India
Department of Orthopaedics,Jawaharlal Nehru Medical College, Sawangi Meghe , Wardha
Wardha
MAHARASHTRA
442001
India
MAHARASHTRA
442001
India |
| Phone |
7999309155 |
| Fax |
|
| Email |
kevinkawde26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Sawangi Meghe Wardha 44201 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Orthopaedics Department, Jawaharlal Nehru Medical college, Sawangi Meghe, Wardha Maharashtra 442001 |
| Type of Sponsor |
Private 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 Kevin Kawde |
Jawaharlal Nehru Medical College |
Orthopaedics department, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA |
8871514291
kevinkawde26@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: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Open reduction internal fixation with proximal femoral nail A |
After explaining about the procedure, written informed consent will be taken. Prior to the procedure patients will be investigated with routine pre-operative investigations, Antero-posterior and lateral Radiographs Pelvis with hip joint as well as ipsilateral femur. Patients will be kept nil per oral 6 hours prior to the procedure. Patient will be taken on fracture table under strict aseptic precautions, fracture site will be reduced with traction and manipulation under c-arm guidance. Fracture will be fixed with proximal femoral nail A. Patient will be followed up for the duration of 6 months. |
| Intervention |
Open reduction internal fixation with proximal femoral nail A2 |
After explaining about the procedure, written informed consent will be taken. Prior to the procedure patients will be investigated with routine pre-operative investigations, Antero-posterior and lateral Radiographs Pelvis with hip joint as well as ipsilateral femur. Patients will be kept nil per oral 6 hours prior to the procedure. Patient will be taken on fracture table under strict aseptic precautions, fracture site will be reduced with traction and manipulation under c-arm guidance. Fracture will be fixed with proximal femoral nail A2. Patient will be followed up for the duration of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with Intertrochanteric femur fractures , more than 20 years of age , fit for surgery , skeletally matured individuals, and isolated femur fractures |
|
| ExclusionCriteria |
| Details |
Skeletally immature individuals, patient unfit for surgery , patient with compound fractures , patient with pathological fractures , patient with hip deformities patient with closed physis |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient will be assessed regarding the clinical, functional and surgical outcomes |
The clinical, functional and surgical outcomes of PFN A and A2 in intertrochanteric femur fracture in 6 weeks, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
22/01/2024 |
| 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="3"
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
|
To compare surgical and functional outcome of PFN A and A2 in intertrochanteric femur fractures |