| CTRI Number |
CTRI/2022/10/046918 [Registered on: 31/10/2022] Trial Registered Prospectively |
| Last Modified On: |
28/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Management of fractures |
|
Scientific Title of Study
|
"Clinical and radiological assessment of patients with intertrochanteric fracture
managed with proximal femoral nail with helical blade- A Cohart study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madan Mohan Nagar |
| Designation |
Professor and Head of Department |
| Affiliation |
Rohilkhand Medical college and hospital, Bareilly |
| Address |
Room no. 1012
Department of orthopaedics,
RMCH , BAREILLY
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9837147854 |
| Fax |
|
| Email |
ahanagar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madan Mohan Nagar |
| Designation |
Professor and Head of Department |
| Affiliation |
Rohilkhand Medical college and hospital, Bareilly |
| Address |
Room no. 1012
Department of orthopaedics,
RMCH , BAREILLY
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9837147854 |
| Fax |
|
| Email |
ahanagar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil Godara |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical college and hospital, Bareilly |
| Address |
Room no. 1012
Department of orthopaedics,
RMCH , BAREILLY
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9837147854 |
| Fax |
|
| Email |
nikhilgodara20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical college and Hospital, Bareilly |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital |
| Address |
Rohilkhand medical college and hospital, Pilibhit bypass Road, opp. Suresh Sharma nagar , Bareilly |
| 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 Nikhil Godara |
Rohilkhand Medical College and Hospital |
Room no. 1012
Department of Orthopaedic
Bareilly
UTTAR PRADESH |
8130371864
nikhilgodara20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RMCH, Bareilly, U.P. |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with trochanteric fracture of femur .
Patient with inter-trochanteric fracture with sub-trochanteric extensio |
|
| ExclusionCriteria |
| Details |
Open fractures.
Pure sub-trochanteric fracture femur.
Patients who are medically not fit for anaesthesia or surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the clinical and radiological outcome of proximal femoral nail with helical blade in the management of patients with intertrochanteric fractures. |
During post operative phase |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate clinical and radiological outcome at 6,12 and 24 weeks.
|
During post operative phase. |
| To evaluate clinical outcome using Modified Harris Hip Score after surgery. |
During post operative phase |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
01/11/2022 |
| 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
|
Adams CI, Robinson CM, Court-Brown CM, McQueen MM. Prospective randomised controlled trial of an intramedullary nail versus dynamic hip screw and plate for intertrochanteric fractures of femur. J Orthop Trauma. 2001;15:394-400
Sharma A, Sethi A, Sharma S. Treatment of stable intertrochanteric fractures of the femur with proximal femoral nail versus dynamic hip screw:a comparative study. Chandigarh. Rev Bras Ortop. 2018:53(4):477-81
Sharma A, Mahajan A, John B. A comparison of the Clinico-Radiological Outcomes with Proximal Femoral Nail (PFN) and Proximal Femoral Nail Antirotation (PFNA) in Fixation of Unstable Intertrochanteric Fractures. Ludhiana. Journal of Clinical and Diagnostic Research. 2017,Vol-11(7):RC05-9
Naja AS, Hanna T, Tamim H, Sagieh S. Predictors of Mechanical Failure rate in Reduction of Intertrochanteric Fracture of the Femur using Proximal Femoral Nail with Helical Blade. J Orthopaedics Rheumatology. 2018;5(1):5-9 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Intertrochanteric fracture is one of the most common fractures in Orthopaedics, particularly in the geriatric age group. Majority of the elderly population is osteoporotic, so they are generally more prone and can sustain the fracture even with a minor fall. Trochanteric fractures unite readily, but if there is failure in maintaining the alignment these can malunite. Surgical treatment has been accepted as the standard protocol of management of intertrochanteric fractures throughout the world. DHS (Dynamic Hip Screw) is the most commonly used extramedullary implant. It has stood the test of time and has continued to be the gold standard in the management of intertrochanteric fractures, especially stable fractures. Introduction of intra-medullary concept and devices, Gamma nail in 1988 & later proximal femoral nail (PFN) in 1996 by AO/ASIF group, the intramedullary devices have gained attention and popularity globally. PFN (Proximal Femoral Nail) is an intramedullary device, it was designed to overcome the implant related complications of DHS and to facilitate the surgical management of unstable intertrochanteric fractures. Advantages are – better biomechanical strength, shorter duration of surgery, preservation of fracture biology, earlier weight bearing, smaller incision and less wound related complications. With time implant underwent more changes and finally Proximal Femoral Nail with Helical Blade was introduced in 2003. The helical blade of PFN achieves better cancellous bone compaction in femoral neck (particularly in osteoporotics), thereby decreasing the risk of secondary displacement, and it has superior resistance to rotation and varus collapse as compared to conventional PFN. The new PFNA device ensures reliable fixation with low mechanical complications. A study is however needed to confirm the superior biomechanical performance of PFN with helical blade (PFNA) by assessing the functional outcomes, clinical and radiological results in the patients with intertrochanteric fractures. In our study we will assess functional outcome using radiological and clinical evaluation at our centre i.e. RMCH, Bareilly , U.P. |