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.

Completed

• Conditions: Fracture of thoracic vertebra, (2) ICD-10 Condition: S320||Fracture of lumbar vertebra,

• Registration Number: CTRI/2020/06/026211
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education Research

Brief Summary

This study is a randomized, open labelled , parallel group, single center trial comparing short term outcomes in patients of thoracolumbar fractures without neurodeficit and without posterior ligamentous complex(PLC) treated operatively by percutaneous pedicle screw fixation vs those treated non operatively. patients who satisfy the inclusion criteria will be explained the details of the study and consent taken for participation. following which he will be randomized and respective group will be alloted. patient will then undergo the respective SOP(standard operative procedure - i.e operative management for operative group and conservative management for conservative group) followed for the particular group. thereafter he will be discharged and asked to followup at the end of three weeks since injury, for assessment of outcomes, i.e. primary outcome - pain measure by vas score, secondary outcomes - disability (measured by EUROQOL 5L, ODI score, return to work, analgesic useage), radiological outcomes(cobbs angle), any complications that arise in the two study arms. following the assessment patient will be kept on regular follow up as per institutional guidelines for management of these group of patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Study Completion: 2022-05-13
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	3 weeks since time of injury.

Secondary Outcome Measures

Name	Time	Method
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
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.	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 weeks	3 weeks since time of injury.

Trial Locations

Locations (1)

Jawaharlal Institute of Postgraduate Medical Education & Research; 🇮🇳 Pondicherry, PONDICHERRY, India

Jawaharlal Institute of Postgraduate Medical Education & Research

🇮🇳Pondicherry, PONDICHERRY, India

Duddukunta Vishal Reddy

Principal investigator

9502026355

dvishalreddy@gmail.com