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Comparing Rod and Plate Fixation Methods for Fractures Near the Kne

A Randomized Controlled Trial Comparing Retrograde Femoral Nailing and Distal Femoral Locking Plate Fixation in the Management of Distal Femur Fractures - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103478
Enrollment
124
Registered
2026-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: S724- Fracture of lower end of femur

Interventions

Intervention1: Retrograde femoral nail: Surgical fixation of distal femur fracture using a retrograde intramedullary nail Control Intervention1: Distal femoral locking plate: Surgical fixation of dist

Sponsors

christian medical college and research
Lead Sponsor
Depuy Synthes
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 75 years with closed and open distal femur fractures. Fractures treated within 14 days of injury.

Exclusion criteria

Exclusion criteria: Pathological fractures B/l Femur Fractures. Distal Femur fracture with metaphyseal comminution AO 33- C3 requiring Dual plate or Nail plate construct .

Design outcomes

Primary

MeasureTime frame
To assess post-operative Rotational Malalignment between the two techniques Timepoint: To assess post-operative Rotational Malalignment between the two techniques in immediate post op period( baseline)

Secondary

MeasureTime frame
To compare the rate of radiographic union between retrograde femoral nailing & distal femoral locking plate fixation in distal femur fractures. To assess post-operative mechanical alignment, including coronal, sagittal between the two techniques Functional outcomes using fully patient-reported score Lower Extremity Functional score (LEFS) & SF-12 at 6 weeks, 3 months, 6 months, & 12 months. To analyze the incidence of complications such as infection, implant failure, & need for reoperation. To assess differences in operative parameters such as time, blood loss, & fluoroscopy usage. Timepoint: 6 weeks, 3 months, 6 months, & 12 months

Countries

India

Contacts

Public ContactDr Viju Daniel Varghese

Christian Medical College

viju.daniel@gmail.com09344566387

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026