サプリメントの耐久性ロッド構築 - 長いセグメントの後部器具を装着した脊椎固定術のための柔軟なロッド技術
補助ロッド コンストラクトの耐久性 - 長いセグメントの後部器具を装着した脊椎固定術用の補助ロッド テクニック (SMART): デュアル ロッド コンストラクトを使用した多施設のレトロスペクティブ比較研究
This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites.
調査の概要
詳細な説明
This multicenter retrospective comparative cohort study will enroll 1244 patients, who underwent primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. By comparing two groups of patients, ie, patients treated with supplementary rod constructs vs dual-rod constructs, in the setting of long-segment posterior instrumented spinal fusion, this study aims to provide quality evidence regarding the benefits of supplementary rod constructs in reducing the risk of RFs and other mechanical complications. This study shall provide the first long-term clinical evidence on clinical outcome and benefit of supplementary rod constructs.
All participating surgeons will be asked to identify a time point, denoted as X, when they started using predominantly either supplementary rod constructs or dual-rod constructs for long-segment posterior TL instrumented spinal fusion. This time point X must be on or before December 31, 2020 (the last eligible date for the index surgery). Participating surgeons will be instructed to select the time point X to be as early within the collection window as feasible to maximize the available FU period.
Once the time point X is identified for a participating surgeon, medical records of patients treated by this surgeon will be reviewed to identify consecutive eligible patients with the index surgery done between the time point X and December 31, 2020, inclusive. In the case that an eligible patient had undergone several surgeries during this period, the first primary or revision of long-segment posterior TL instrumented fusion using either a supplementary rod construct or a dual-rod construct is defined as the index surgery.
Patients will then be grouped based on the rod constructs into either the supplementary rod construct group or dual-rod construct group.
The study has two FU periods:
- The first FU period is the first 2 years after the index surgery. The primary analysis will be done using data from the first 2 years of FU.
- The second FU period ends on December March 31, 20232024. The duration of this FU therefore ranges from 3 years and 3 months to 10 years and 3 months.
The primary study endpoint is the occurrence of the first RF within 2 years after the index surgery.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Viola Grünenfelder
- 電話番号：+41 79 696 33 97
- メール：viola.gruenenfelder@aofoundation.org
研究連絡先のバックアップ
- 名前：Alix Frischknecht
- 電話番号：+41 79 606 41 48
- メール：alix.frischknecht@aofoundation.org
研究場所
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California
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Redwood City、California、アメリカ、94588
- 募集
- Stanford Spine Clinic
-
コンタクト：
- Serena Hu, MD
- メール：shu3@stanford.edu
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Sacramento、California、アメリカ、95819
- 募集
- University of California
-
コンタクト：
- Yashar Javidan
- メール：yjavidan@ucdavis.edu
-
San Francisco、California、アメリカ、94144
- 終了しました
- UCSF Spine Center
-
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Maryland
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Baltimore、Maryland、アメリカ、21287
- 募集
- John Hopkis Hospital
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コンタクト：
- Khaled Kebaish
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Minnesota
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Minneapolis、Minnesota、アメリカ、55454
- 募集
- University of Minnesota Medical Center
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コンタクト：
- David Polly, MD
- メール：pollydw@umn.edu
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Missouri
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St Louis、Missouri、アメリカ、63110
- 募集
- Washington University in St. Louis, School of Medicine
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コンタクト：
- Brian Neuman
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St Louis、Missouri、アメリカ、63310
- 完了
- Washington University in St. Louis, School of Medicine, Saint Louis, Missouri 63110
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New York
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New York、New York、アメリカ、10032
- 募集
- Columbia University / NYP Och Spine Hospital
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コンタクト：
- Zeeshan Sardar
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Virginia
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Charlottesville、Virginia、アメリカ、22908
- 募集
- University of Virginia
-
コンタクト：
- Justin S Smith, MD, PhD
- 電話番号：434-243-6339
- メール：jss7f@virginia.edu
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コンタクト：
- Judith G Beenhakker
- メール：JGB3P@uvahealth.org
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Kolkata、インド
- 募集
- Kothari Medical Centre
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コンタクト：
- Saumayajit Basu, MD
- メール：saumyajitbasu@hotmail.com
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Calgary、カナダ、T2N 2T9
- 募集
- University of Calgary Spine
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コンタクト：
- Ganesh Swamy
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Toronto、カナダ、M5T 2S8
- 募集
- University of Toronto
-
コンタクト：
- Stephen Lewis
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コンタクト：
- Christopher Nielsen
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Barcelona、スペイン、08035
- 募集
- Hospital Vall d´Hebron
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コンタクト：
- Ferran Pellisé, MD
- メール：24361fpu@comb.es
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Istanbul、トルコ（Türkiye）
- 募集
- Acibadem Maslak Hospital
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コンタクト：
- Caglar Yilgor, MD
- メール：caglaryilgor@gmail.com
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コンタクト：
- Ahmet Alanay
- メール：aalanay@gmail.com
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Hong Kong、中国
- 完了
- Duchess of Kent Children's Hospital
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Hamamatsu、日本、431-3192
- 完了
- Hamamatsu University School of Medicine
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Tokyo、日本、113-8654
- 募集
- University of Tokyo
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コンタクト：
- So Kato, Prof
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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
Patients who underwent long-segment posterior thoracolumbar (TL) instrumented fusion
説明
Inclusion Criteria:
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Age 45 years and older.
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Patients receiving long-segment posterior TL instrumented fusion using either supplementary rod constructs or dual-rod constructs (the index surgery).
- Long-segment is defined as the UIV at a thoracic level and the LIV at the sacrum/ilium.
- Supplementary rod constructs are defined as: in addition to the traditional two primary rods, at least one supplementary rod (eg, accessory rods or satellite rods) is used, and at least one supplementary rod and one primary rod (ie, at least two rods) together must span multiple (≥ 2) vertebral levels. The supplementary rod constructs do not include rods connected end-to-end or side-to-side that do not bridge multiple vertebral levels.
- The index surgery can be a primary surgery or a revision surgery.
- The index surgery, staged or non-staged, must use posterior spinal fusion but can be in combination with other approaches such as an anterior procedure.
-
If the index surgery is a revision surgery, the primary rods must be replaced in the revision surgery, with the exception of Harrington or Luque rods which can remain in place.
o If the Harrington or Luque rods remain in situ, they must already have the UIV at the thoracic level and the LIV at the sacrum/ilium, or an extension of the existing Harrington or Luque is performed such that the UIV is at the thoracic level and the LIV at the sacrum/ilium.
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The index surgery was performed between January 1, 2014, and December 31, 2020, inclusive.
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Minimum 3 months of FU after the index surgery.
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Ability to provide informed consent according to the IRB/EC defined and approved procedures if applicable for retrospective data analysis.
Exclusion Criteria:
- Spinal fusion performed for acute trauma (ie, ≤ 1 year of trauma).
- Spinal fusion performed for tumor.
- Spinal fusion performed for infection.
- Patients with Parkinson's Disease.
- Patients with neuromuscular disorders.
- Patients with spine malignancies requiring chemo- or radiation therapy.
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：COHORT
- 時間の展望：RETROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
primary/revision long-segment posterior TL instrumented fusion with dual-rod constructs
The index surgery for this study is the primary or revision of long-segment posterior TL instrumented fusion using dual-rod construct. |
long-segment posterior TL instrumented fusion with either supplementary rod constructs or dual-rod constructs. |
|
primary/revision long-segment posterior TL instrumented fusion with supplementary rod constructs
The index surgery for this study is the primary or revision of long-segment posterior TL instrumented fusion using either a supplementary rod construct. |
long-segment posterior TL instrumented fusion with either supplementary rod constructs or dual-rod constructs. |
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 |
|---|---|---|
|
Rod fracture (RF)
時間枠：2 years
|
Incidence of rod fracture(s) |
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to rod fracture
時間枠：2 years
|
Time to the first rod fracture after index surgery |
2 years
|
|
Time to rod fracture
時間枠：10 years and 3 months
|
Time to the first rod fracture after index surgery |
10 years and 3 months
|
|
Configurations of supplementary rod constructs
時間枠：Baseline
|
Descriptions of configurations of supplementary rod constructs |
Baseline
|
|
Treatment for rod fracture
時間枠：10 years and 3 months
|
Descriptions of different treatment strategies for rod fractures |
10 years and 3 months
|
|
Recurrent RFs
時間枠：10 years and 3 months
|
Incidence of recurrent rod fractures |
10 years and 3 months
|
|
Other mechanical failures
時間枠：10 years and 3 months
|
Other mechanical failures other than rod fractures |
10 years and 3 months
|
|
Surgical complications
時間枠：10 years and 3 months
|
Selective surgical complications |
10 years and 3 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Justin S Smith, MD, PhD、Professor of Neurosurgery Chief of Spine Division, Fellowship Director University of Virginia
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
その他の研究ID番号
- SMART
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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