Follow up Patients With Thoracolumbar Spondylodiscitis Surgically Treated by Posterior Approach

• Conditions: Spondylodiscitis

• Registration Number: NCT04749082
• Lead Sponsor: Assiut University

Brief Summary

To evaluate the long term outcomes of patients with thoracolumbar spondylodiscitis treated surgically by posterior approach.

Outcomes include bony fusion, neurological improvement, pain improvement, implant related complication, recurrence of infection and or reoperation rate

Detailed Description

spondylodiscitis is characterized by infection that primarily affects the intervertebral disc and adjacent vertebrae. The estimated incidence of spondylodiscitis, ranging from 0.2 to 10 per 100,000 inhabitants per year, has increased in recent years, which is likely associated with an aging population, higher prevalence of chronic disease, and more effective diagnostic techniques. Spondylodiscitis is a life-threatening disease with a mortality rate of 2-20% that is often associated with potential complications, such as paraspinal abscess, epidural abscess, meningitis, spinal instability, and neurologic deficiency. The relapse rates were reported to be as high as 32% in the literature. The aims of this study are to evaluate improvements, complications, recurrence and reoperation rates in Assiut university hospitals.

Study Timeline

• Study First Submitted: 2021-01-05
• Study Start: 2021-01-31
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-09
• Last Update Submitted: 2021-02-09
• Study First Posted: 2021-02-10
• Last Update Posted: 2021-02-10
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• • All patients had thoracolumbar spondylodiscitis from number 1 thoracic vertebra till number 1 sacral vertebra.

  • Treated surgically by posterior approach only.

Exclusion Criteria

• • Patients with incomplete follow up.

  • Multifocal discitis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bony fusion success	2 years	the degree of bridging bone across the fused vertebral bodies by using x-ray, CT scan and MRI if needed

Secondary Outcome Measures

Name	Time	Method
modified Oswestry disability index	2 years	for patient quality of life postoperative
visual analogue scale	2years	the amount of pain sensed by the patient pre and post-operative
American spinal injury Association (ASIA) Impairment score	2 years	to asses neurological outcomes pre operative and at 2 years follow up.