Skip to content

This is a clinical trial to study the short term effects in patients with spine fractures without any weakness or loss of sensation in both hands and legs when they are treated with operation versus when they are treated by bed rest.

An open labelled randomized control trial comparing short term outcomes in thoracolumbar fractures without neurological deficit and without obvious posterior ligamentous complex injury treated by percutaneous fixation vs no fixation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/026211
Enrollment
24
Registered
2020-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: S320- Fracture of lumbar vertebra Health Condition 2: S220- Fracture of thoracic vertebra

Interventions

Intervention1: Percutaneous pedicle screw fixation for thoracolumbar spine fractures.: Under general anesthesia, patients positioned in prone on a radiolucent table for spine surgery with chest, abdom
the guide wire was then removed after adequate positioning of the screw. Using the same approach, pedicle screws are inserted into above and below the fractured vertebra including the fractured level.

Sponsors

Jawaharlal Institute of Postgraduate Medical Education Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults of both sexes aged 18 years or over, with a radiologically confirmed, recent (less than or at one week) isolated thoracolumbar fracture without neurodeficit and obvious PLC injury.

Exclusion criteria

Exclusion criteria: ANY Patients with a preferred choice of treatment modality Polytrauma patients Patients with other associated musculoskeletal trauma Pathological fractures of vertebral body. Previous spine surgeries. Presence of back pain prior to thoracolumbar fractures. Patients with obvious PLC disruption on radiological evaluation Pregnant patients.

Design outcomes

Primary

MeasureTime frame
In patients of thoracolumbar fractures without obvious PLC injury and without neurological deficit, treated by percutaneous fixation vs no fixation, To compare the intensity of pain (measured by vas score) between the 2 groups at the end of 3 weeks since time of injury. Timepoint: 3 weeks since time of injury.

Secondary

MeasureTime frame
In patients of thoracolumbar fractures without PLC injury and without neurological deficit, treated by percutaneous fixation vs no fixation, To compare between the 2 groups the radiological outcome measured by cobbs angle at the end of 3 weeks.Timepoint: 3 weeks since time of injury.;In patients of thoracolumbar fractures without PLC injury and without neurological deficit, treated by percutaneous fixation vs no fixation, to compare between the 2 groups, the extent of disability measured by ODI score, EUROQOL-5D, return to work (Denis work scale), number of days of hospital stay and analgesic usage at end of 3 weeks since time of injury Timepoint: 3 weeks since time of injury.;In patients of thoracolumbar fractures without PLC injury and without neurological deficit, treated by percutaneous fixation vs no fixation, To identify and record any complications arising due to treatment irrespective of which treatment given among the two groups at the end of 3 weeksTimepoint: 3 weeks since time of injury.

Countries

India

Contacts

Public ContactDuddukunta Vishal Reddy

JIPMER

drdeep_sharma@yahoo.com9489146554

Outcome results

None listed

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