Randomized Controlled Trial of Open Stabilisation Versus TPS
A Randomized Controlled Trial Comparing Open Spinal Stabilisation and Percutaneous Solution (TPS) Surgery in Patients With Metastatic Spinal Disease.
Spread of cancer to the spinal column is a growing problem in patients with cancer. It can cause a number of problems including pain, instability and neurologic problems. If left untreated, progressive weakness, numbness and bladder/bowel disturbance occurs. The aim of treatment is to help with pain and to reduce the risk of these neurological problems. This treatment has traditionally been radiotherapy to the spine. Surgery has always meant large open operations with a long recovery time and significant risk of complications. There has been new technology that has allowed less invasive operations to take place to stabilise the spine. The aim is to relieve the pressure on the spinal cord in addition to stabilising the spinal cord. These techniques are called 'minimally invasive' and include surgical techniques such as cement augmentation and percutaneous instrumentation.
The aim of this study is to compare traditional open operations with these new minimally invasive techniques to see if they do result in reduced complications and quicker recovery in addition to achieving the goals of surgery.
調査の概要
研究の種類
段階
- 適用できない
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:
- Has an age ≥ 18 years
- Is suitable for radiotherapy
- Has been assessed by the oncologist
- Has symptoms of pain
- Is diagnosed with metastatic spinal pain from MRI findings with or without biopsy
- Technically possible to perform the surgery
- Is willing and able to comply with required followup questionnaires
- Is able to understand the risks and benefits of participating in the study
- Understands and has signed the informed consent form.
- Life expectancy of > 3 months
Exclusion Criteria:
- Active systemic infection or infection localized to the site of implantation
- Allergy or sensitivity to Polyether ether ketone (PEEK), Titanium or Tantalum
- A bleeding disorder precluding from invasive surgery
- Rapid neurological deterioration requiring urgent surgery which would be delayed to the detriment of the patient by including in this study
研究計画
研究はどのように設計されていますか？
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Posterior percutaneous instrumentations
|
|
|
他の：Traditional open surgery with pedicle screw fixation
|
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 |
|---|---|
|
Visual analogue pain (VAS) scores
時間枠：3 months
|
3 months
|
|
Visual analogue pain (VAS) scores
時間枠：6 months
|
6 months
|
|
Visual analogue pain (VAS) scores
時間枠：1 year
|
1 year
|
|
Visual analogue pain (VAS) scores
時間枠：2 years
|
2 years
|
|
Oswestry disability score
時間枠：3 months
|
3 months
|
|
Oswestry disability score
時間枠：6 months
|
6 months
|
|
Oswestry disability score
時間枠：1 year
|
1 year
|
|
Oswestry disability score
時間枠：2 years
|
2 years
|
|
EuroQoL Questioonaire (EQ-5D)
時間枠：3 months
|
3 months
|
|
EuroQoL Questioonaire (EQ-5D)
時間枠：6 months
|
6 months
|
|
EuroQoL Questioonaire (EQ-5D)
時間枠：1 year
|
1 year
|
|
EuroQoL Questioonaire (EQ-5D)
時間枠：2 years
|
2 years
|
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
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。