Spondylodiscitis Clinical Trial
Official title:
Long Term Follow up of Patients With Thoracolumbar Spondylodiscitis Treated Surgically by Posterior Approach in Assiut University Hospitals
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
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
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
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 |
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