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Completed

NCT Number: NCT03472131

Unilateral Posterolateral Approach for Spondylodiskitis

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.

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Key information

Conditions

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

Age range

44 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Unilateral Posterolateral Approach and Debridement

Procedure

Titanium cage insertion supplemented by screw fixation

Other

Primary outcomes

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

    Time frame: 2 years

    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.

Secondary outcomes

  1. Survival rate at 2,5 years

    Time frame: 2,5 years

    Revision surgery or "worst case scenario"

  2. Survival rate at 10 years

    Time frame: 10 years

    Revision surgery or "worst case scenario"

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Collaborators

  • St. Andrew's General Hospital, Patras, Greece

Registry information

Official study title

Unilateral Posterolateral Approach for Disc Debridement and Titanium Cage Insertion Supplemented by Contralateral Transfascial Screw Fixation for Sick Patients Suffering From Septic Thoracolumbosacral Spondylodiscitis

Acronym: SPDTIS

Important dates

Study start
2004
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2018
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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