CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis

NCT03524209 | Unknown

• 1 other identifier: 6751
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 15

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.

Conditions

Spondylodiscitis

Keywords

Spondylodiscitis; spinal infection; back pain; quality of life; fusion; minimal invasive surgery; brace treatment

Outcome Measures

Primary Outcomes (7)

• 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)

  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)

  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)

  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)

  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)

  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)

  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)

  Post treatment 2 years

Secondary Outcomes (5)

• 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

• - 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

• Analysis of correlation between kyhphosis / fusion and VAS / QoL scores

  Change of measures between pre treatment and during 2 years after treatment

• Course of CRP

  Change of value between pre treatment and during 3 months after treatment

• Documentation of secondary complications after percutaneous instrumentation

  Change between pre treatment and during 2 years after treatment

Other Outcomes (1)

• Documentation, reporting and analysis of potential complications

  Change between pre treatment and during 2 years after treatment

Study Arms (2)

Surgery

OTHER

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

Brace

OTHER

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

Interventions

Percutaneous instrumentation of the thoracolumbar spine DEVICE

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)

Surgery

Brace OTHER

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

Brace

Eligibility Criteria

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

You may qualify if:

• adult patients presenting acute pyogenic spondylitis of the thoracolumbar spine
• back pain at a minimum of 4 out of 10 on VAS
• Diagnostic MRI and disc puncture + microbiological analysis required for antibiotic treatment and/or blood culture
• Vertebral body involvement (osteolysis) \< 50% of VB height documented on CT

You may not qualify if:

• postoperative pyogenic spondylitis or infection after spinal instrumentation spinal tuberculosis and mycosis
• contra-indications for surgery or general anaesthesia
• general septic conditions acute endocarditis documented by sonography
• patients presenting another major abcess or an epidural abscess
• Absence of vertebral body involvement (osteolysis) on CT or minor VB involvement less than 10% of VB height (surgery not indicated)
• Major destruction of vertebral body (\>50%) on CT (surgery mandatory) Patients with concomitant bacterial endocarditis

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (15)

CHU de Bordeaux - Hôpital Pellegrin - Unité d'orthopédie-traumatologie rachis I

Bordeaux, 33076, France

Location

CHU de CAEN

Caen, 14033, France

Location

Hôpital Beaujon - Service de Chirurgie Orthopédique et Traumatologie

Clichy, 92110, France

Location

CHU François Mitterand - Bocage central - Service de Neurochirurgie

Dijon, 21079, France

Location

CHU de GRENOBLE

Grenoble, 38043, France

Location

CHU Lyon - Hôpital Pierre Wertheimer - Service de Neurochirurgie C et chirurgie du rachis

Lyon, 69003, France

Location

CHU Marseille - Hôpital Timone - Service de chirurgie orthopédique et traumatologique

Marseille, 13005, France

Location

Hôpital Gui de Chauliac - Service de Neurochirurgie

Montpellier, 34090, France

Location

Hôpital Central - Service de Neurochirurgie

Nancy, 54035, France

Location

CHU Hôtel Dieu - Service de Neurotraumatologie

Nantes, 44093, France

Location

CHU Nice - Hôpital Pasteur 2 - Unité de Chirurgie Rachidienne

Nice, 06001, France

Location

Hôpital Pitié - Salpêtrière - Service de Chirurgie orthopédique

Paris, 75013, France

Location

Hôpital européen Georges-Pompidou - Service d'Orthopédie/Traumotologie

Paris, 75015, France

Location

CHU Reims - Hôpital Maison Blanche - Service de Neurochirurgie

Reims, 45092, France

Location

Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Discitis; Back Pain

Interventions

Braces

Condition Hierarchy (Ancestors)

Spondylitis; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Yann Philippe CHARLES, MD

  Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective selection of patients with pyogenic spondylitis fulfilling above mentioned inclusion criteria is performed with subsequent randomization into treatment group 1 versus treatment group 2 after informed consent. Group1 are patients treated by minimally invasive surgery and group 2 are patients treated by thoracolumbar brace. Radiologic deformity assessment is performed on lateral thoracolumbar radiographs in standing position. A modified sagittal index measuring the angulation between cranial endplate of cranial vertebra and caudal endplate of the caudal vertebra as this parameter is normalized to 0°. Assessment of osteolysis at vertebral bodies on CT expressed as a ratio of vertebral body height in the mid-sagittal plane in comparison to non-infected vertebral bodies adjacent to the index level. Assessment of complete fusion, partial fusion, pseudarthrosis is performed on CT at 1-year FU. Type and length of antibiotic treatment

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: May 14, 2018
• Study Start: August 21, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)