CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis

Not Applicable

Active, not recruiting

• Conditions: Spondylodiscitis

• Registration Number: NCT03524209
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-05-11
• Study First Posted: 2018-05-14
• Study Start: 2019-08-21
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of VAS for back pain for brace versus percutaneous instrumentation	Post treatment 2 years	VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)

Secondary Outcome Measures

Name	Time	Method
- Comparison of influence of both treatment on kyphotic deformity - Comparison of fusion rates versus pseudarthrosis for both treatments	Change of measures between pre treatment and during 2 years after treatment	Radiographic measurements by modified sagittal index on lateral radiographs in standing position
Course of CRP	Change of value between pre treatment and during 3 months after treatment	Routine blood tests for documentation of CRP
Comparison of quality of life (QoL) by EQ-5D for brace versus percutaneous instrumentation	Change of score between pre treatment and during 2 years after treatment	EQ-5D-3L questionnaire filled out by the patients
Analysis of correlation between kyhphosis / fusion and VAS / QoL scores	Change of measures between pre treatment and during 2 years after treatment	Radiographic measurements by modified sagittal index on lateral radiographs in standing position
Documentation of secondary complications after percutaneous instrumentation	Change between pre treatment and during 2 years after treatment	Comparison of influence of both treatment

Trial Locations

Locations (15)

CHU de Bordeaux - Hôpital Pellegrin - Unité d'orthopédie-traumatologie rachis I; 🇫🇷 Bordeaux, France

CHU de CAEN; 🇫🇷 Caen, France

Hôpital Beaujon - Service de Chirurgie Orthopédique et Traumatologie; 🇫🇷 Clichy, France

CHU François Mitterand - Bocage central - Service de Neurochirurgie; 🇫🇷 Dijon, France

CHU de GRENOBLE; 🇫🇷 Grenoble, France

CHU Lyon - Hôpital Pierre Wertheimer - Service de Neurochirurgie C et chirurgie du rachis; 🇫🇷 Lyon, France

CHU Marseille - Hôpital Timone - Service de chirurgie orthopédique et traumatologique; 🇫🇷 Marseille, France

Hôpital Gui de Chauliac - Service de Neurochirurgie; 🇫🇷 Montpellier, France

Hôpital Central - Service de Neurochirurgie; 🇫🇷 Nancy, France

CHU Hôtel Dieu - Service de Neurotraumatologie; 🇫🇷 Nantes, France

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