Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04749082
Other study ID # spondylodiscitis surgery
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 31, 2021
Est. completion date July 1, 2021

Study information

Verified date February 2021
Source Assiut University
Contact Micheal B Elia, resident
Phone 01282682989
Email mikelbassem@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date July 1, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers
Gender All
Age group 20 Years to 85 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Berbari EF, Kanj SS, Kowalski TJ, Darouiche RO, Widmer AF, Schmitt SK, Hendershot EF, Holtom PD, Huddleston PM 3rd, Petermann GW, Osmon DR, Infectious Diseases Society of America. 2015 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults. Clin Infect Dis. 2015 Sep 15;61(6):e26-46. doi: 10.1093/cid/civ482. Epub 2015 Jul 29. Review. — View Citation

El-Sharkawi MM, Said GZ. Instrumented circumferential fusion for tuberculosis of the dorso-lumbar spine. A single or double stage procedure? Int Orthop. 2012 Feb;36(2):315-24. doi: 10.1007/s00264-011-1401-9. Epub 2011 Nov 10. — View Citation

Kamal AM, El-Sharkawi MM, El-Sabrout M, Hassan MG. Spondylodiscitis: experience of surgical management of complicated cases after failed antibiotic treatment. SICOT J. 2020;6:5. doi: 10.1051/sicotj/2020002. Epub 2020 Feb 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Bony fusion success the degree of bridging bone across the fused vertebral bodies by using x-ray, CT scan and MRI if needed 2 years
Secondary modified Oswestry disability index for patient quality of life postoperative 2 years
Secondary visual analogue scale the amount of pain sensed by the patient pre and post-operative 2years
Secondary American spinal injury Association (ASIA) Impairment score to asses neurological outcomes pre operative and at 2 years follow up. 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT05806905 - Spondylodiscitis Cases at Assiut University Hospital
Recruiting NCT05610098 - Gene Expression Profiles in Spinal Tuberculosis.
Completed NCT02554227 - Cytokine Profiles and suPAR in Spondylodiscitis
Suspended NCT01542853 - The Value of PET/CT in Diagnosing Residual Disease in Patients With Spinal Infection N/A
Not yet recruiting NCT04436328 - Conservative Versus Surgical Treatment of Native Vertebral Osteomyelitis N/A
Completed NCT05486494 - Spine Registry University Hospital of Cologne- Department of Orthopedics
Completed NCT04655950 - Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.
Active, not recruiting NCT03524209 - CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis N/A