| CTRI Number |
CTRI/2025/03/083182 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| 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
|
To compare two types of surgeries in patients undergoing treatment for broken thigh bone. |
|
Scientific Title of Study
|
Comparison of Surgical, Functional and Radiological Outcomes following Integrated Screw and Nail System (ISNS)Versus Helical-Blade Anti- rotation Proximal Femoral Nail (PFNA2) in Trochantreic fractures - a Randomised Control 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 |
Samuel Kirubakaran |
| Designation |
Post Graduate |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Dept of Orthopaedics, PIMS, Pondicherry
Pondicherry PONDICHERRY 605014 India |
| Phone |
9444435842 |
| Fax |
|
| Email |
samdkiru@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Naveen Sake |
| Designation |
Associate professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Dept of Orthopaedics, PIMS, Pondicherry
Pondicherry PONDICHERRY 605014 India |
| Phone |
9949550202 |
| Fax |
|
| Email |
naveen.sake@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Samuel Kirubakaran |
| Designation |
Post Graduate |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Dept of Orthopaedics, PIMS, Pondicherry
Pondicherry PONDICHERRY 605014 India |
| Phone |
9444435842 |
| Fax |
|
| Email |
samdkiru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical sciences, Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry,
Country - India,
Pincode - 605014 |
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical science |
| Address |
PIMS, Kalapet, Puducherry - 605014 |
| 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 Samuel Kirubakaran D |
Pondicherry Institute of Medical Science |
Department of Orthopaedics, No-101, PIMS, Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014 Pondicherry PONDICHERRY |
9444435842
samdkiru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S721||Pertrochanteric fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Helical Blade (PFNA2) |
It is impacted around the cancellous bone by compaction anchored in the femoral head which provides rotational and angular stability. |
| Intervention |
Integrated Screw and Nail System (ISNS) |
It is a type of fixation , in which two cephalo-cervical screws that provide linear compression and additional resistance to the rotation of the femoral head. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All cases of isolated unilateral intertrochanteric femur fractures
2. Age more than18 years,
3. Patients consented to participate are included in the study. |
|
| ExclusionCriteria |
| Details |
1. All open injuries and Pathological fractures
2. Patients refused to participate in this program,
3. Patients with associated injuries (such as head injury, abdominal injury, or other bone injuries),
4. Patients with a subtrochanteric femur fracture,
5. Patients with a intra-capsular femur fracture. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Operative time in minutes ,
Blood loss (ml) ,
Number of C-Arm shots |
base line - during the day of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cut through, DVT, embolism , femoral neck angle, Hip apex angle, neck shaft angle, ROM, knee pain/ stiffness, Weight bearing, Modified harris hip score, Katz index |
2 weeks, 6 weeks, 12 weeks, 18 weeks & 24 weeks after surgery |
|
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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)
|
04/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" 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
|
Hip fractures are one of the most prevalent orthopaedic injuries
as more than a million human subjects are prone for the same. Nearly half of all hip
fractures are intertrochanteric femur fractures (IFFs), which are more common among the
elderly and are often as a result of low-energy traumas. In order to achieve a satisfactory
early recovery of the injured patients, surgical treatment is mandatory to manage these
fractures. The gold standard therapy for stable intertrochanteric fractures, was earlier the
dynamic hip screw (DHS) implant. However, they were found inadequate for the stabilizing
fractures of the unstable kind. Contrarily, as opposed to extramedullary devices such as
DHS, proximal femoral nails (PFN) have a biomechanical advantage because of their closer
location to the vector of force as opposed to extramedullary devices, and shorter moment arm. Moreover, based on the results of several earlier reports, intramedullary fixation may be
preferable to extramedullary fixation for hip fracture patients as the functional scores are
higher and there is a lower risk of implant failure and reoperation. Further, only a
minimally invasive procedure is required to implant a PFN. Therefore, a closed reduction of
the fracture, aids to maintain the haematoma, and the surgeon can perform a minimally
invasive procedure with least possible soft-tissue dissection, thereby lowering surgical
trauma, blood loss, infection, and wound complications.
Healing of the bones is significantly managed by the interfragmentary linear compression
provided by the lag screw in majority of the PFNs. One or two lag screws, integrated or
locked lag screws, and a wedge block that offers rotational stability are some of the PFN
designs available in the market. Clinical and radiological evaluations of only two distinct
PFNs have been studied extensively. However, only few studies have compared the
differences between ISNS and PFNA2 with respect to its surgical outcome, and radiological
outcome in patients treated with closed reduction and internal fixation for IFFs and this study aims to bring in more light in this area.
|