Bone Marrow Aspirate Concentration in Posterior Cervical Fusion (BMAC)
The purpose of this research is to test if that combining bone marrow aspirate (removing bone marrow with a needle) concentration with locally harvested (collected) autograft (patient's own bone from another part of the body) for use as the bone graft results in equal rates of a successful procedure (fusion), as compared to current best practice in high-risk patients undergoing posterior cervical fusion.
Hypothesis: Bone marrow aspirate concentration combined with locally harvested autograft results in equivalent rates of bony fusion, as compared to current best practice in high-risk patients undergoing posterior cervical decompression and fusion.
調査の概要
状態
条件
詳細な説明
100 consecutive high-risk patients who meet the following inclusion criteria: are 18-75 years of age, require a cervical spine MRI as part of their standard of care show evidence of CSM, and have cervical alignment allowing posterior instrumented fusion. High-risk will be defined as having a diagnosis of rheumatoid arthritis, osteoporosis, current smoker, or BMI >30. Patients will be excluded if they have any MRI incompatible devices, have any prior cervical instrumentation, require an instrumented anterior cervical fusion, or have an underlying neurological condition affecting the cervical spine (MS, ALS, HIV).
Patients will be sequentially randomized to one of two treatment groups. Group I, will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft). Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. To assist with analysis, we will collect information from patients' hematology results, obtained per their standard of care pre-operative workup. All patients will be treated post-operatively at the discretion of the treating surgeon. All patients will follow-up at 6 weeks, 3 months, 6 months, 12 months, and 24 months. At the 6, 12, and 24-month follow-up all patients will undergo flexion/extension X-rays, fusion will be defined as less than 2 mm or motion. A cervical spine CT may also be obtained at 24 months on all patients to assess fusion at the discretion of the treating surgeon. All radiographic assessments of fusion will be made by a Washington University staff radiologist, blinded to patient treatment.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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Saint Louis、Missouri、アメリカ、63110
- Washington University in St. Louis 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
説明
Inclusion Criteria:
- Age between 18 and 75
- Have at least one of the following high risk qualifications: BMI >30, Rheumatoid Arthritis, Osteoporosis, Current smoker
- Able to cooperate in the completion of standardized outcome measures (multiple questionnaires)
- Willing and able to comply with study protocol
- Symptomatic cervical myelopathy and/or radiculopathy
- Scheduled for cervical alignment, allowing management with a posterior approach
Exclusion Criteria:
- MRI incompatible device
- History of prior cervical instrumentation
- Requires an instrumented anterior cervical fusion
- History of underlying neurological condition affecting the cervical spine (MS, Amyotrophic Lateral Sclerosis, HIV)
- Pre-existent neurologic disorder or mental disorder that would preclude accurate evaluation (psychiatric disease, Parkinson's disease, Alzheimer's disease)
- History of previous cervical fusion at the operative site
- Pregnant
- Active malignancy
- Previous history of posterior cervical decompression
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
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Group 1 - Surigical Best Practice
Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)
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実験的:Group 2 - autograft/BMAC
Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.
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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 Fusion
時間枠:6 months, 12 months, 24 months
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Rate of fusion - (6, 12, and 24 months) Rate of fusion will be assessed by flexion extension X-rays at routine follow-up, translation method (<2mm) and/or by computed tomography (CT) scan at 2 year post-operatively.
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6 months, 12 months, 24 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physical and Mental Health From Subject's Point of View
時間枠:24 months
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Short Form 36 (SF-36) is a profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
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24 months
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Neck Pain Affects Every Day Activities
時間枠:24 Months
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Questionnaire that helps determine how a subject's neck pain affects their ability to manage every day activities.
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24 Months
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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 (実際)
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 (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
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