| CTRI Number |
CTRI/2024/05/067400 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison between different implants in surgical management of proximal hip fractures |
|
Scientific Title of Study
|
A Prospective Double-Blinded Parallel 3-Arm Randomized Controlled Trial to Study the Clinical and Radiological Outcomes of Integrated Twin Compression Screw Nail, Single Blade Cement Augmented and Non Augmented Cephalomedullary Nail in the Treatment of Intertrochanteric Femur Fractures |
| 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 Lijin Raj P R |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Orthopaedics, All India Institute of Medical Sciences (AIIMS) , Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8921967382 |
| Fax |
|
| Email |
lijin7224@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Trikha |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Orthopaedics, Jai Prakash Narayan Apex Trauma Center, Inner Ring Road, Near Shanti Avedna Sadan, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9650430733 |
| Fax |
|
| Email |
vivektrikha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lijin Raj P R |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Orthopaedics, All India Institute of Medical Sciences (AIIMS) , Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8921967382 |
| Fax |
|
| Email |
lijin7224@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Jain Prakash Narayan Apex Trauma Center JPNATC |
| Address |
Department of Orthopaedics, Inner Ring Road, Near Shanti Avedna Sadan, Ansari Nagar West, New Delhi, Pin- 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Lijin Raj P R |
Jain Prakash Narayan Apex Trauma Center (JPNATC) |
Department of Orthopaedics, Inner Ring Road, Near Shanti Avedna Sadan, Ansari Nagar West, Delhi, Pin- 110029
New Delhi
DELHI |
8921967382
lijin7224@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Twin Compression Screw Nail (INTERTAN) |
20 patients will be operated using INTERTAN nail.This is a proximal femoral nailing device used in surgical management of proximal femoral fractures. It has a unique design of two cephalo-cervical screws in an integrated mechanism, which allows linear intraoperative compression at the fracture site and also provides rotational stability of the proximal fragment. Duration of follow up - 6 months. |
| Comparator Agent |
Single Blade Cement Augmented (TFNA NAIL) |
20 patients will be operated using TFNA nail. This is a proximal femoral nailing device used in surgical management of proximal femoral fractures which utilizes a helical blade for fixation in the femoral head instead of a lag screw. This design is intended to improve resistance to varus collapse and improved rotational control of the medial fracture segment theoretically reducing the rate of cutâ€out. Duration of follow up - 6 months |
| Intervention |
TFNA nail with cement augmentation |
20 patients will be operated using cement augmented TFNA nail. TFNA nail has small porosities at the tip of the screw or blade which allows us to inject PMMA cement into the femoral head. It is mainly important in osteoporotic bones which is seen in elderly population. Cement augmentation enhances the fixation stability of TFNA blades and screws and also enhances the cut-out resistance in proximal femoral fractures. Duration of follow up - 6 months. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to undergo the procedure with explained consent.
2.All patients with unstable Intertrochanteric fractures presenting to the institution during this period.
3.Unstable intertrochanteric fracture patterns such as reverse oblique, posteromedial comminuted fractures, and fractures with sub-trochanteric extension.
4.Patients equal to or more than 60 years of age.
5.Low energy trauma.
6.Fractures less than 4 weeks old. |
|
| ExclusionCriteria |
| Details |
1. Patients with open fractures.
2. Pathological fractures due to bony lesions (not due to osteoporosis) and Poly trauma patients with expected delay in primary and immediate fixation.
4. Patients not willing to participate in the study.
5. Patients with other associated fractures in the upper limbs/ ipsilateral lower limb.
6. Patients below 60 years of age
7. High-velocity trauma.
8. Fractures more than 4 weeks old.
9. Inability to walk prior to surgery. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the radiological outcomes of Integrated Twin Compression Screw Nail (ITCSN), Single Blade Cement Augmented (SBCNA) and Non Augmented (SBCN) Cephalomedullary Nail in the treatment of intertrochanteric femur fractures using pre-operative and post-operative radiographs and CT scans at stipulated follow-up intervals with Tip Apex Distance (TAD) and collapse as primary outcome measures. |
Post Operative Day-0
Post Operative Day-2
Post Operative Week-4
Post Operative Week-12
Post Operative Week-24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the clinical outcomes of Integrated Twin Compression Screw Nail (ITCSN), Single Blade Cement Augmented (SBCNA) and Non Augmented (SBCN) Cephalomedullary Nail in the treatment of intertrochanteric femur fractures using the incidence of fixation failure and reoperation rate.
2.To compare the functional outcomes of Integrated Twin Compression Screw Nail (ITCSN), Single Blade Cement Augmented (SBCNA) and Non Augmented (SBCN) Cephalomedullary Nail in the treatment of intertrochanteric femur fractures using Modified Harris Hip Score at 6 months follow-up and VAS Score at POD-0, 48 Hrs and 4 weeks of follow-up. |
Post Operative Day-0
Post Operative Day-2
Post Operative Week-4
Post Operative Week-12
Post Operative Week-24 |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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="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
|
This is a prospective, double-blinded, parallel 3-arm randomized controlled trial with a 1:1:1 allocation ratio which will be conducted in Department of Orthopedics, Jai Prakash Narayan Apex Trauma Centre, AIIMS and AIIMS, New Delhi in an expected sample size of 60, in patients presenting with proximal femoral fractures, using 1.Integrated Twin Compression Screw Nail (ITCSN), 2.Non Augmented Single Blade Cephalomedullary Nail (SBCN), 3.Cement Augmented Single Blade Cephalomedullary Nail (SBCNA). The primary objective of the study is to compare the radiological outcomes of these implants using pre-operative and post-operative radiographs and CT scans at stipulated follow-up intervals with Tip Apex Distance (TAD) and collapse as primary outcome measures. The secondary objectives of the study is to compare the clinical outcomes of these implants using the incidence of fixation failure and reoperation rate, to compare the functional outcomes of these implants using Modified Harris Hip Score at 6 months follow-up and VAS Score at POD-0, 48 Hrs and 4 weeks of follow-up. |