Unilateral Posterolateral Approach for Spondylodiskitis

NCT03472131 | Completed

• 1 other identifier: SPONDYLODISKITIS2018
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This retrospective study assess the efficacy and safety of a posterolateral unilateral approach for debridement and titanium cage insertion supplemented by contralateral transfascial screw fixation for sick patients suffering from septic thoracolumbosacral spondylodiskitis. Hematogenous pyogenic spondylodiskitis requires surgical intervention in cases of development of neurological signs, spinal instability, progressive spinal deformity and abscess. When operative treatment is indicated, an anterior approach by open thoracotomy or by a thoraco-abdominal approach or combined anterior and posterior approaches are recommended. In cases of severe sick patients anterior approach is associated with high morbidity and mortality.

Conditions

Discitis

Keywords

Spondylodiscitis; Titanium Cage; Posterolateral Debridement; Immunosuppressed; Less Invasive; Spine Infection

Outcome Measures

Primary Outcomes (1)

• The extent of spinal cord injury (SCI) defined by the American Spinal Injury Association (ASIA) Impairment Scale

  Grade A Complete lack of motor and sensory function below the level of injury (including the anal area) Grade B Some sensation below the level of the injury (including anal sensation) Grade C Some muscle movement is spared below the level of injury, but 50 percent of the muscles below the level of injury cannot move against gravity. Grade D Most (more than 50 percent) of the muscles that are spared below the level of injury are strong enough to move against gravity. Grade E All neurologic function has returned.

  2 years

Secondary Outcomes (2)

• Survival rate at 2,5 years

  2,5 years

• Survival rate at 10 years

  10 years

Study Arms (1)

Septic spondylodiscitis

EXPERIMENTAL

A unilateral posterolateral approach and debridement with titanium cage insertion supplemented by screw fixation for severe sick patients suffering from septic spondylodiscitis

Procedure: Unilateral Posterolateral Approach and Debridement; Other: Titanium cage insertion supplemented by screw fixation

Interventions

Unilateral Posterolateral Approach and Debridement PROCEDURE

Septic spondylodiscitis

Titanium cage insertion supplemented by screw fixation OTHER

Septic spondylodiscitis

Eligibility Criteria

• Age: 44 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single-level thoracic, thoracolumbar, lumbar or lumbosacral spondylodiskitis
• Medical comorbidities were present in all 20 patients. These included diabetes mellitus, chronic renal insufficiency, advanced heart insufficiency, hypertension, cortisone abuse, drug abuse and/or advanced age (\>65y).

Sponsors & Collaborators

• University Hospital of Patras: lead
• St. Andrew's General Hospital, Patras, Greece: collaborator

Related Publications (1)

• Korovessis P, Syrimpeis V, Tsekouras V, Baikousis A, Vardakastanis K, Fennema P. A unilateral less invasive posterolateral approach for disc debridement and titanium cage insertion supplemented by contralateral transfascial screw fixation for high-morbidity patients suffering from septic thoracolumbosacral spondylodiscitis. Eur J Orthop Surg Traumatol. 2019 Aug;29(6):1187-1197. doi: 10.1007/s00590-019-02434-2. Epub 2019 Apr 16.

  PMID: 30993521 DERIVED

MeSH Terms

Conditions

Discitis

Interventions

Debridement

Condition Hierarchy (Ancestors)

Spondylitis; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Panagiotis Korovessis, PhD

  General Hospital of Patras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 21, 2018
• Study Start: January 1, 2004
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 27, 2018

Record last verified: 2018-03