PRESTIGE Observational Study
Prestige artificial disc replacement is an alternative treatment option with 16 years of experience addressing the unmet needs of surgical fusion interventions. Previous studies on the PRESTIGE® cervical disc have proven the safety and effectiveness of artificial disc surgery with level I evidence.
The PRESTIGE Observational Study is intended to collect prospectively observational data primarily on the Quality of Life (QoL).
調査の概要
状態
条件
詳細な説明
Degenerative cervical disc disease is associated with a very high burden to the patient and the society. If conservative treatment options fail, surgical interventions are the last treatment option.
Symptomatic disc degeneration leads to neck pain, which can radiate to the scapula and arm, with dumbness and tingling, and sometimes grasping and walking difficulties. At an advanced stage, muscle weakness can be observed in the nerve territory.
The quality of life and functionality of patients with therapy-resistant (conservatively treated) severe degeneration of the disc is greatly impaired, as they suffer from intense pain and thus disability. Patients of working age were significantly more impacted by their symptoms than older patients. They are no longer able to fully participate in everyday activities.
Cervical neck pain resulting from degenerative disc disease is associated with a major economic burden for payers.
Traditional cervical surgical decompressions and fusions are currently the most common treatment option. Despite good treatment success rates, fusions are associated with a negative impact on the normal kinematics of the spine, long recuperation times and long absence from work. Prestige artificial disc replacement is an alternative treatment option.
The PRESTIGE Observational Study is intended to collect information on Quality of Life (QoL) prior and after PRESTIGE® Cervical Disc surgery; data on pain prior of participation to the study, drug regiment and X-ray evaluation throughout the course of the study will be obtained. In addition adverse events and economic data will be documented.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Athens、ギリシャ
- Agia Olga Hospital
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Kuwait、クウェート
- Al-Salam International Hospital
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Kuwait City、クウェート
- Al-Salam International Hospital
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Kuwait City、クウェート
- Razi Hospital for Orthopedic Surgery
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Jeddah、サウジアラビア
- King Faisal Specialist Hospital & Research Center
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Nové Zamky、スロバキア
- NsP Nové Zámky Hospital
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Belgrade、セルビア、11000
- Neurosurgical Clinic KCS
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Belgrade、セルビア
- Neurosurgical Clinic KCS
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Nis、セルビア、18000
- Clinical Center Nis Neurosurgical Clinic
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Niš、セルビア
- Clinical Center Nis
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Novi Sad、セルビア
- Clinical Center of Vojvodina
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Novi Sad、セルビア、21000
- Clinical Center of Vojvodina Neurosurgical Clinic
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Plzen、チェコ共和国、32318
- Hospital Plzen - Lochotin
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Plzen、チェコ共和国
- Hospital Plzen - Lochotin
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Prague、チェコ共和国
- University Clinic Motol
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Budapest、ハンガリー
- National Center for Spinal Disorders
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Budapest、ハンガリー、1126
- National Center for Spinal Disorders
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Konstancin、ポーランド、05-510
- Centrum Ksztalcenia I Rehabilitcji
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Konstancin、ポーランド
- Centrum Ksztalcenia I Rehabilitcji
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Konstancin、ポーランド
- Centrum Rehabilitacji im.prof. M.Weissa "STOCER"
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Konstancin-Jeziorna、ポーランド、05-510
- Centrum Rehabilitacji im.prof.M.Weissa "STOCER"
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Opole、ポーランド、45-418
- State Hospital- Wojewodzkie Centrum
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Szczecin、ポーランド、70-891
- Specialist Hospital Prof. Alfreda Sokolowskiego
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Szczecin、ポーランド
- Specialist Hospital Prof. Alfreda Sokolowskiego
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Zakopane、ポーランド、34-500
- Orthopaedic University Hospital in Zakopane
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Zakopane、ポーランド
- Orthopaedic University Hospital in Zakopane
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Zielona Gora、ポーランド、65-046
- State Hospital- Szpital Wojewodzki
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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:
- Patient must be willing to sign a Patient Data Release Form.
- Patient with degenerative disc disease (DDD) who is scheduled to receive a PRESTIGE® Cervical Disc and fulfills the indications according to the product description.
Exclusion Criteria:
- Patient fulfills any contraindication according to the product description.
- Patient has not reached the age of legal consent according to local laws.
- Patient has diabetes.
- Patient has Body Mass Index (BMI) > 35.
- Patient has affected disc not between C3/C4 and C6/C7.
- Patient with instability of cervical spine.
- Patients who will receive extensive 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
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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EQ-5D
時間枠：2 years
|
The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI). EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death. |
2 years
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Neck Disability Index (NDI) Score
時間枠：2 years
|
The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI). The NDI is a self-reported questionnaire designed to provide information on how neck pain affects the patient's ability to manage in everyday life. It contains questions on 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. NDI results can be presented as a raw score or as a percent. When presenting it as a raw score, each section is scored on a 0 to 5 rating scale and the result is summarized to a total score with a maximum score of 50. This raw score can also be doubled and expressed as a percentage. Zero points or 0% means no activity limitations and 50 points or 100% means complete activity limitation. |
2 years
|
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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Duration of Pain Prior to Enrollment
時間枠：Baseline visit
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Documentation of duration of pain prior to enrollment
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Baseline visit
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Intervertebral Disc Space
時間枠：2 years
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2 years
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協力者と研究者
捜査官
- 主任研究者：Jan Štulik, MUDr、University Clinic Motol
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
その他の研究ID番号
- PRESTIGE Observational Study
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。