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 Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 60.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients with open fractures.
- •Pathological fractures due to bony lesions (not due to osteoporosis) and Poly trauma patients with expected delay in primary and immediate fixation.
- •Patients not willing to participate in the study.
- •Patients with other associated fractures in the upper limbs/ ipsilateral lower limb.
- •Patients below 60 years of age
- •High-velocity trauma.
- •Fractures more than 4 weeks old.
- •Inability to walk prior to surgery.
Outcomes
Primary Outcomes
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.
Time Frame: Post Operative Day-0 | Post Operative Day-2 | Post Operative Week-4 | Post Operative Week-12 | Post Operative Week-24
Secondary Outcomes
- 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.)
Investigators
Dr Lijin Raj P R
AIIMS New Delhi