Evaluation of the Prevalence of Germs Slow Growth in the Intervertebral Disc (IVD) During Spinal Surgery (DISCO-PROP)
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.
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Creteil、フランス、94010
- Henri Mondor Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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Fragments disc withdrawn during cures herniated disc surgeries by posterior way.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
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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
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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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Presence or lack of germs slow growth in disc by standard culture and molecular biology technique (16S RNA).
時間枠：Visit 2 (surgery day)
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Visit 2 (surgery day)
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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