Thoracolumbar Burst Fracture Management: Randomized Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-23

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Between December 2019 to December 2022, patients presenting to causalty department with TL fracture type A3 and A4 with a TL AOSIS scores of 4 and 5 were randomly managed either by conservative or operative management.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment

NCT02827214

Thoracolumbar Burst Fracture

COMPLETED

Mangement of Spine Fracture

NCT06458309

Spine Fracture

RECRUITING NA

Short Term Outcomes of Fracture Odontoid Management

NCT05042596

Spine Injury

COMPLETED

Mid-Term Outcomes Of Fracture Odontoid Management in Assiut University

NCT05842694

Cervical Spine Fracture

UNKNOWN

Randomized Trial With an Observational Component of Non-operative Versus Operative Treatment for AO Type A3 Fractures

NCT02179697

Spinal Fractures

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conservative management group was treated by bed rest and brace for 3 weeks followed by early mobilization. Operative management group received management through Short-segment fixation with one or two screws in fractured vertebra when applicable with posterior spinal fusion. Patients were evaluated both clinically regarding pain (VAS score), disability by Oswestry Disability Index (ODI score) and neurological status. Radiological evaluation included local sagittal spinal alignment, including pre- and post- management Cobb angle and local segment kyphosis. Bony fusion was also evaluated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Evaluation of the Validity of Thoracolumbar AO Spine Injury Score (TL AOSIS) in A3 and A4 Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

operative group

Group Type ACTIVE_COMPARATOR

short segment TPF

Intervention Type PROCEDURE

short segment transpedicular screw fixation with one or two screws in fractured vertebra

conservative group

Group Type ACTIVE_COMPARATOR

conservative management

Intervention Type PROCEDURE

brace and bed rest with mobilization as tolerated

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

short segment TPF

short segment transpedicular screw fixation with one or two screws in fractured vertebra

Intervention Type PROCEDURE

conservative management

brace and bed rest with mobilization as tolerated

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Skeletally mature patients (age 21-55 years old), TL spine fractures of types A3 and A4 with TL AOSIS score 4 or 5. These include different variables; A4N0, A3N1, A3N2 and A3M1N0.

Exclusion Criteria

* Osteoporotic fractures and skeletally immature patients, associated comorbidities (e.g. bleeding disorders, rheumatoid arthritis), or any fracture type other than A3 and A4, and significant neurological compromise.

Minimum Eligible Age

21 Years

Maximum Eligible Age

57 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No