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

NCT ID: NCT02892617

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-12-31

Brief Summary

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.

Conditions

Prevalence of Germs; Spinal Surgery; Anterior Disc Disease; Modic 1

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Bacteriological analysis of disc

Intervention Type: OTHER

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

Bacteriological analysis of disc

Intervention Type: OTHER

Interventions

Bacteriological analysis of disc

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henri Mondor Hospital

Créteil, , France

Countries

France

Other Identifiers

2014-A01831-44

Identifier Type: -

Identifier Source: org_study_id