- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02284945
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Posterior percutaneous instrumentations
|
|
Övrig: Traditional open surgery with pedicle screw fixation
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Visual analogue pain (VAS) scores
Tidsram: 3 months
|
3 months
|
Visual analogue pain (VAS) scores
Tidsram: 6 months
|
6 months
|
Visual analogue pain (VAS) scores
Tidsram: 1 year
|
1 year
|
Visual analogue pain (VAS) scores
Tidsram: 2 years
|
2 years
|
Oswestry disability score
Tidsram: 3 months
|
3 months
|
Oswestry disability score
Tidsram: 6 months
|
6 months
|
Oswestry disability score
Tidsram: 1 year
|
1 year
|
Oswestry disability score
Tidsram: 2 years
|
2 years
|
EuroQoL Questioonaire (EQ-5D)
Tidsram: 3 months
|
3 months
|
EuroQoL Questioonaire (EQ-5D)
Tidsram: 6 months
|
6 months
|
EuroQoL Questioonaire (EQ-5D)
Tidsram: 1 year
|
1 year
|
EuroQoL Questioonaire (EQ-5D)
Tidsram: 2 years
|
2 years
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NE11/9972
- 11/YH/0404 (Annan identifierare: Research Ethics Committee)
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