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Comparing different treatment options (plates) in injury to upper part of leg

Randomized Control Trial comparing Radiological, Clinical and Functional Outcomes following Uniaxial vs Polyaxial Plating in Management of Tibial Plateau Fractures and CT Guided Mapping of Proximal Tibial Fractures in Indian Population

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023280
Enrollment
40
Registered
2020-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

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

Interventions

Intervention1: Polyaxial Plate: Polyaxial Plating in Proximal tibial fracture will be undertaken during single surgery which will take approx 2 hours Control Intervention1: Uniaxial Plate: Uniaxial Pl

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All patients with tibial plateau fracture presenting to the institution in this period 2.Age > 18 years and 3.Fractures involving the proximal tibia 4.Patients giving consent for study 5.Patients operated within 21 days of injury

Exclusion criteria

Exclusion criteria: 1.Age 60 years 2.Prior knee surgery 3.Pre operative history of knee pain or arthritis 4.Prior infection at the site of injury 5.Patients not giving consent 6.Open fractures 7.Fractures associated with vascular injuries in the same limb 8.Polytrauma patients and patients with fractures in the ipsilateral limb 9.Patients operated after 21 days following injury

Design outcomes

Primary

MeasureTime frame
1.To assess clinical outcomes based on Post-operative Pain, Walking Capacity, Range of Motion, Knee Extension, Stability of knee joint clinically, maintenance of reduction and alignment 2.To assess radiological outcomes based on articular depression, condylar widening, progression of osteoarthritis, varus/valgus angulation 3.To assess functional outcomes measured by the Knee Society Severity Score and Knee Injury and Osteoarthritis Outcome Score Timepoint: 2 WEEKS 6 WEEKS 3 MONTHS 6 MONTHS

Secondary

MeasureTime frame
1.To make a template tibia based on CT scans of normal tibia in the Indian Population. 2.To make and analyse a ‘Heat Map’ of fracture lines seen in the Indian population presenting to a Level I Trauma Centre and identify common morphology of proximal tibial fractures. Timepoint: PRE OPERATIVE CT SCANS WILL BE USED

Countries

India

Contacts

Public ContactDr Vivek Trikha

All India Institute of Medical Sciences, New Delhi

vivektrikha@gmail.com9650430733

Outcome results

None listed

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