Evaluation of the Prevalence of Germs Slow Growth in the Intervertebral Disc (IVD) During Spinal Surgery (DISCO-PROP)

September 1, 2016 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of the Prevalence of Germs Slow Growth in the Intervertebral Disc (IVD) During Spinal Surgery: a Single-center Prospective Observational Study

Low back pain is one of the most frequent reasons for consultation in rheumatology. There is a strong correlation between low back pain, and the presence of a type of Modic 1 signal on MRI.

The anomaly Modic 1 results in a hypointense signal T1-weighted images and hyperintense on T2-weighted sequences (including T2 STIR and / or Fat Sat) and contrast enhancement of the endplates after gadolinium injection; it corresponds to a replacement of normal cancellous bone of fibrovascular tissue.

The origin of this inflammatory process Modic 1 into the vertebra is still unknown.

infectious hypothesis was raised, including contamination by germs called "slow-growth" such as Propionibacterium acnes (PA).

Many studies interesting Bacteriological analysis of disc material found the presence of bacteria (prevalence between 0 and 54%).

A recent clinical trial evaluating the efficacy of antibiotic treatment compared to placebo in low back pain with Modic 1; a show effectiveness of this treatment on the different clinical parameters evaluated.

However skin contamination is not formally excluded, particularly in patients previously infiltrated (including epidural).

Our hypothesis is that the slow-growing bacteria are not involved in Modic 1 type of disc disease, and the possible presence of PA or other slow-growing bacteria in samples obtained discal posterior approach would be related to intraoperative contamination or during preoperative spinal infiltrations The main objective is to assess the prevalence of germs slow growth in the intervertebral disc in the spinal surgery by anterior disc disease in type 1 Modic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94010
        • Henri Mondor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Disc samples taken during spine surgery during installation of disc prostheses or inter somatic cages made by anterior approach in type discopathies Modic.

Fragments disc withdrawn during cures herniated disc surgeries by posterior way.

Patients were recruited from the orthopedic service and Neurosurgery at Henri Mondor Hospital in Creteil

Description

Inclusion Criteria:

  • Major patients accepted to participate in the study and who signed an informed consent.
  • Patients with low back pain lasting for more than 6 months, disabling, with disc disease type 1 Modic eligible for a disc prosthesis or arthrodesis anterior approach.
  • Patients underwent surgery for nerve root pain by disc herniation on MRI viewable with a radio-clinical concordance with or without Modic 1 disc disease in the operated disc

Exclusion Criteria:

  • Lumbar spine surgery history within 12 months and / or presence of osteosynthesis material.
  • Immunocompromised patients (HIV, cancer, immunosuppressive treatment, lupus, chronic infection, ...)
  • Patients previously treated with antibiotics exceeding 15 days during last 3 months prior enrollment for a period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Patients with low back pain lasting for more than 6 months, debilitating, with the presence of type 1 Modic disc disease on MRI at the operated disc, eligible for a disc prosthesis or arthrodesis anterior approach
Other: Bacteriological analysis of disc
Group 2
Patients underwent surgery for nerve root pain by disc herniation on MRI viewable with a radio-clinical concordance with or without Modic 1 disc disease in the operated disc
Other: Bacteriological analysis of disc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence or lack of germs slow growth in disc by standard culture and molecular biology technique (16S RNA).
Time Frame: Visit 2 (surgery day)
Visit 2 (surgery day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-A01831-44

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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