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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Posterior percutaneous instrumentations
|
|
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Ander: Traditional open surgery with pedicle screw fixation
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Visual analogue pain (VAS) scores
Tijdsspanne: 3 months
|
3 months
|
|
Visual analogue pain (VAS) scores
Tijdsspanne: 6 months
|
6 months
|
|
Visual analogue pain (VAS) scores
Tijdsspanne: 1 year
|
1 year
|
|
Visual analogue pain (VAS) scores
Tijdsspanne: 2 years
|
2 years
|
|
Oswestry disability score
Tijdsspanne: 3 months
|
3 months
|
|
Oswestry disability score
Tijdsspanne: 6 months
|
6 months
|
|
Oswestry disability score
Tijdsspanne: 1 year
|
1 year
|
|
Oswestry disability score
Tijdsspanne: 2 years
|
2 years
|
|
EuroQoL Questioonaire (EQ-5D)
Tijdsspanne: 3 months
|
3 months
|
|
EuroQoL Questioonaire (EQ-5D)
Tijdsspanne: 6 months
|
6 months
|
|
EuroQoL Questioonaire (EQ-5D)
Tijdsspanne: 1 year
|
1 year
|
|
EuroQoL Questioonaire (EQ-5D)
Tijdsspanne: 2 years
|
2 years
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NE11/9972
- 11/YH/0404 (Andere identificatie: Research Ethics Committee)
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