An interventional study of Percutaneous instrumentation of the thoracolumbar spine and Brace in Spondylodiscitis, sponsored by University Hospital, Strasbourg, France. Status unknown at 15 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Other
Pyogenic spondylitis in adults is usually treated by antibiotics according to bacteria evidenced in a diagnostic intervertebral disc puncture. Brace treatment is associated in patients presenting back pain and a risk for vertebral body collapse due to infection with subsequent kyphotic deformity of the thoracolumbar spine. Percutaneous minimally invasive posterior spinal instrumentation has evolved over the last decade and indications in infections arouse over the last years. This procedure is interesting as it is performed through small skin incisions only. It avoids paravertebral muscle dissection and thus limits intraoperative bleeding and access morbidity. Recent retrospective data suggests that this internal fixation represents a theoretical advantage over brace treatment by lowering back pain and increasing patient's quality of life in the short run, up to 3 months, but no randomized study was published. The patient's autonomy, including walking ability and daily activities, might improve more rapidly after a percutaneous procedure. Additionally, the sagittal alignment of the thoracolumbar spine could be better maintained by internal fixation, which might prevent progression into kyphosis and improve long-term outcome. The hypothesis is the superiority of percutaneous minimally invasive instrumentation on brace treatment in term of quality of life, back pain and quality of osseous healing.
Safety and efficacy of percutaneous for the indication of pyogenic spondylitis has been demonstrated retrospectively on small cohort studies, which is in line with our clinical experience. Although this therapeutic concept seems applicable to patients with spondylitis, the theoretical clinical benefit of minimally invasive surgery remains hypothetic and unclear compared to brace treatment, which might still be regarded as the gold standard.
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Patients with spondylodiscitis are operated by percutaneous instrumentation and receive an antibiotic treatment according to the bacterium evidenced in the initial diagnostic intervertebral disc puncture (6 weeks to 3 months according to CRP course)
Device: Percutaneous instrumentation of the thoracolumbar spine
Patients with spondylodiscitis are wearing a thoracolumbar brace for 3 months and receive an antibiotic treatment according to the bacterium evidenced in the initial diagnostic intervertebral disc puncture (6 weeks to 3 months according to CRP course)
Other: Brace
The spine is stabilized cranially and caudally of the level of spondylodiscitis. The percutaneous instrumentation consists of a rod and pedicle screw construct. The vertebrae are instrumented through minimal skin incisions using a fluoroscopic guidance or a spinal navigation system based on 3D imaging.
Also known as: minimal invasive surgery (MIS)
Brace treatment is associated in patients presenting back pain and a risk for vertebral body collapse due to infection with subsequent kyphotic deformity of the thoracolumbar spine
Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time frame: Pre treatment
Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time frame: Post treatment day 5
Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time frame: Post treatment 6 weeks
Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time frame: Post treatment 3 months
Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time frame: Post treatment 6 months
Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time frame: Post treatment 1 year
Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time frame: Post treatment 2 years
Comparison of quality of life (QoL) by EQ-5D for brace versus percutaneous instrumentation
EQ-5D-3L questionnaire filled out by the patients
Time frame: Change of score between pre treatment and during 2 years after treatment
- Comparison of influence of both treatment on kyphotic deformity - Comparison of fusion rates versus pseudarthrosis for both treatments
Radiographic measurements by modified sagittal index on lateral radiographs in standing position
Time frame: Change of measures between pre treatment and during 2 years after treatment
Analysis of correlation between kyhphosis / fusion and VAS / QoL scores
Radiographic measurements by modified sagittal index on lateral radiographs in standing position
Time frame: Change of measures between pre treatment and during 2 years after treatment
Course of CRP
Routine blood tests for documentation of CRP
Time frame: Change of value between pre treatment and during 3 months after treatment
Documentation of secondary complications after percutaneous instrumentation
Comparison of influence of both treatment
Time frame: Change between pre treatment and during 2 years after treatment
Documentation, reporting and analysis of potential complications
Comparison of influence of both treatment
Time frame: Change between pre treatment and during 2 years after treatment
Plan to share: No
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