Comparison of safety and efficacy between two surgical process one is single stage surgery via hybrid fixator and other is two stage surgery via knee spaning external fixator followed by plating in a patient of proximal tibia fracture using radiological and functional score

Comparison of safety and efficacy between single stage Surgery external fixation with or without minimally invasive internal fixation and staged internal fixation in patients with high velocity proximal tibia fractures using radiological and functional score A randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110182

Enrollment

Registered

2026-05-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: - Health Condition 2: S821- Fracture of upper end of tibia

Interventions

Intervention1: To Compare the effectiveness of single-stage surgery (External fixation with or without minimally invasive internal fixation) and staged internal fixation in Patients with High-Velocit

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than 18 years, male or female 2. Patient with a high-velocity proximal tibia fracture (SCHATZKER Type IV V VI) 3. Patient giving informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Age Less than18 years 2. Patient with polytrauma necessitating damage control orthopaedics. 3. Patient with multiple lower limb fractures. 4. Patient with Gustilo-Anderson Grade 3 open fractures t hat required primarily wound management. 5. Patients with pregnancy, psychiatric, neurological, and other disorders that affect management and preclude outcome assessment. 6. The patient did not give informed consent to participate in the study

Design outcomes

Primary

Measure	Time frame
To compare the outcomes between single-stage surgery (external fixation with or without minimally invasive internal fixation) and staged internal fixation using functional and radiological score.Timepoint: outcome will be assessed at 2nd week 6th week 3ed month and 6th month	—

Secondary

Measure	Time frame
To assess and compare the complication and re-operation rates between two study groups.Timepoint: 18 months	—

Countries

India

Contacts

Public ContactDR Sourav kumar

All India Institute Of Medical Sciences Bathinda

dr.pankajkristwal@gmail.com9013590572

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026