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CompletedNCT03472131SPDTISUpdated Mar 27, 2018

Unilateral Posterolateral Approach for Spondylodiskitis

An interventional study of Unilateral Posterolateral Approach and Debridement and Titanium cage insertion supplemented by screw fixation in Discitis, sponsored by University Hospital of Patras. Completed. Open to participants aged 44 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-03-27.

Sponsored by University Hospital of Patras · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
44 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

Twenty consecutive sick (ASA>III) patients, 14 men and 6 women, aged 64±14 years, suffering from single level septic thoracolumbosacral spondylodiskitis underwent an one-stage less invasively unilateral posterolateral decompression, insertion of titanium cage\& pedicle screw fixation plus contralateral transfascial pedicle screw fixation.

02

Conditions studied

  • Discitis

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Keywords

  • Spondylodiscitis
  • Titanium Cage
  • Posterolateral Debridement
  • Immunosuppressed
  • Less Invasive
  • Spine Infection
03

Who can participate

Ages eligible
44 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

-

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Septic spondylodiscitis

    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

  • ProcedureUnilateral Posterolateral Approach and Debridement
  • OtherTitanium cage insertion supplemented by screw fixation
05

What researchers measure

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.

    Time frame: 2 years

Secondary outcomes

  1. Survival rate at 2,5 years

    Revision surgery or "worst case scenario"

    Time frame: 2,5 years

  2. Survival rate at 10 years

    Revision surgery or "worst case scenario"

    Time frame: 10 years

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 30993521 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03472131
Lead sponsor
University Hospital of Patras
Collaborators
St. Andrew's General Hospital, Patras, Greece
Responsible party
Vasileios Syrimpeis (Orthopaedic Surgeon, University Hospital of Patras) — Principal investigator
First posted
Mar 21, 2018
Start date
Jan 2004
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Mar 27, 2018

Study contacts

Panagiotis Korovessis, PhD
principal investigator · General Hospital of Patras

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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