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Completed

NCT Number: NCT02892617

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Henri Mondor Hospital

Créteil, 94010, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bacteriological analysis of disc

Other

Primary outcomes

  1. Presence or lack of germs slow growth in disc by standard culture and molecular biology technique (16S RNA).

    Time frame: Visit 2 (surgery day)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: DISCO-PROP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 8, 2016
Registry last updated
Sep 8, 2016

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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