Neurologic Complications in Spinal Deformity Surgery
Evaluation of Neurologic Complications Associated With Surgical Correction of Adult Spinal Deformity: A Prospective, Observational, Multi-center Study
240 subjects with "high risk" adult spinal deformity requiring surgical correction will be enrolled in a prospective multi-center international study. "High risk" patients are defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurologic complications in the form of new motor and sensory deficits will be monitored prospectively in all patients at hospital discharge, and at 6 weeks (± 2 weeks) six months (± 2 months) and 24 months(± 2 months) after the surgery. All new deficits will be adjudicated for relationship to the surgical intervention.
Regression analyses will be used to evaluate the association between patient demographics, co morbidities, treatment history, spinal deformity characteristics, surgical characteristics, non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit after surgery.
調査の概要
詳細な説明
Although the incidence of complications in patients undergoing correction of their spinal deformity has been reported extensively, the majority of these studies were retrospective. There were only five studies, three from a single institution, with prospectively collected data that specifically identified complications. The largest series was from Buchowski et al who reported on 108 patients with fixed sagittal deformity undergoing Pedicle Subtraction Osteotomy (PSO) with a 14% over-all complication rate with motor weakness in 11 patients and neurogenic bladder in one patient, of which 3 were permanent. Yang reported on 35 patients undergoing PSOs with a 46% over-all complication rate and one transient nerve root motor deficit. Ahn in 2002 reported on 83 patients undergoing various osteotomies for sagittal imbalance and reported a 34% over-all complication rate with 3 permanent and 3 transient nerve root deficits.
Given this lack of information, there is a need to determine the true incidence of complications using a prospective multi-center design. There is a need to identify neurologic deficits in a more systematic fashion to include spinal cord, cauda equina and nerve root deficits as well as radiculopathies. The risk factors associated with the occurrence of a complication, especially a neurologic complication, also needs to be more fully elucidated. This is increasingly relevant, as newer surgical techniques allow for more aggressive correction of the spinal deformity that may put the spinal cord and nerve roots at increased risk. Valid data on the incidence and types of neurologic deficits is also needed in order to study newer drugs that are available that may mitigate this risk.
The primary objectives of this study are: (i) to establish the incidence of neurologic deficit in "high risk" adult patients undergoing correction of their spinal deformity of adult spinal deformity and (ii) to identify characteristics associated with increased risk of neurologic complications. Secondary objectives include (i) to determine the incidence of all complications related to surgical correction of "high risk" adult spinal deformity; (ii) to determine the short-term clinical outcomes in patients undergoing correction of their spinal deformity and (iii).to determine amount of radiographic and clinical correction of deformity
研究の種類
入学 (実際)
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94118
- University of California
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Kentucky
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Louisville、Kentucky、アメリカ、40202
- Norton Leatherman Spine Center
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Maryland
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Baltimore、Maryland、アメリカ、21205
- Johns Hopkins University
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- Department of Orthopaedic Surgery, Washington University School of Medicine
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New York
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New York、New York、アメリカ、10021
- Hospital for Special Surgery
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Yew York、New York、アメリカ、10023
- NYU School of Medicine
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Virginia
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Charlottesville、Virginia、アメリカ、22903
- University of Virginia
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Nottingham、イギリス、NG7 2UH
- University Hospital Nottingham, NHS Trust
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Toronto、カナダ、M5T 2S8
- University of Toronto
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Barcelona、スペイン、08035
- Hospital Universitari Vall d'Hebron
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Copenhagen、デンマーク、2100
- Rigshospitalet
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Hong Kong、中国、102
- University of Hong Kong
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NanJing、中国、210008
- Nanjing Drum Tower Hospital
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Hamamatsu、日本、3192
- University School of Medicine
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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
説明
Inclusion Criteria:
- Signed informed consent
- Age 18 to 80 years old inclusive
Diagnosis of adult spinal deformity with an apex of the major deformity in the cervico-thoracic or thoraco-lumbar region (Apex between C7 and L2 inclusive) with any of the following deformity characteristics
- Primary Scoliosis, Kyphosis or Kyphoscoliosis with major Cobb ≥ 80° in the coronal or sagittal plane
- Congenital Spinal Deformity undergoing corrective spinal osteotomy
- Revision Spinal Deformity undergoing corrective spinal osteotomy
- Any patient undergoing a 3-column spinal osteotomy (i.e. Pedicle Subtraction Osteotomy, Vertebral Column Resection) from C7 to L5 inclusive
- Any patient with preoperative myelopathy due to their spinal deformity
- Any patient with ossification of the Ligamentum Flavum or Posterior Longitudinal Ligament and a deformity that needs concomitant reconstruction along with decompression of the spinal cord
Exclusion Criteria:
- Unlikely to comply with follow-up
- Recent history ≤ 3 months of substance dependency or psychosocial disturbance
- Presence of active malignancy
- Has active, overt bacterial infection, systemic or local
- Recent (≤3 months) history of significant spinal trauma/injury/ fracture/malignancy in the spinal region
- Patients with complete, long term paraplegia
- Pregnant or nursing women, unable to agree not to become pregnant for a period of 6 months after surgery
- Prisoners
- Institutionalized individuals
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Surgical treatment
This observational study is examining the outcomes of standard surgical treatments for adult spinal deformity.
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Routinely performed surgical correction of spinal deformity
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rate of treatment-related neurologic complication
時間枠：6 months
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6 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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• Sensory status as measured by the ASIA Sensory Score
時間枠：6 months
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6 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Lawrence Lenke, MD、Scoliosis Research Society
出版物と役立つリンク
便利なリンク
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
本研究に関する用語
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。