Comparison between different implants in surgical management of proximal hip fractures

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 - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067400

Enrollment

Registered

2024-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 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 fem

Eligibility

Inclusion criteria

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

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: Post Operative Day-0 Post Operative Day-2 Post Operative Week-4 Post Operative Week-12 Post Operative Week-24	—

Measure

Time frame

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.Timepoint: Post Operative Day-0 Post Operative Day-2 Post Operative Week-4 Post Operative Week-12 Post Operative Week-24

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Secondary

Measure	Time frame
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.Timepoint: Post Operative Day-0 Post Operative Day-2 Post Operative Week-4 Post Operative Week-12 Post Operative Week-24	—

Measure

Time frame

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.Timepoint: Post Operative Day-0 Post Operative Day-2 Post Operative Week-4 Post Operative Week-12 Post Operative Week-24

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Countries

India

Contacts

Public ContactDr Lijin Raj P R

AIIMS New Delhi

vivektrikha@gmail.com9650430733

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026