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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Posterior percutaneous instrumentations
|
|
|
Annen: Traditional open surgery with pedicle screw fixation
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Visual analogue pain (VAS) scores
Tidsramme: 3 months
|
3 months
|
|
Visual analogue pain (VAS) scores
Tidsramme: 6 months
|
6 months
|
|
Visual analogue pain (VAS) scores
Tidsramme: 1 year
|
1 year
|
|
Visual analogue pain (VAS) scores
Tidsramme: 2 years
|
2 years
|
|
Oswestry disability score
Tidsramme: 3 months
|
3 months
|
|
Oswestry disability score
Tidsramme: 6 months
|
6 months
|
|
Oswestry disability score
Tidsramme: 1 year
|
1 year
|
|
Oswestry disability score
Tidsramme: 2 years
|
2 years
|
|
EuroQoL Questioonaire (EQ-5D)
Tidsramme: 3 months
|
3 months
|
|
EuroQoL Questioonaire (EQ-5D)
Tidsramme: 6 months
|
6 months
|
|
EuroQoL Questioonaire (EQ-5D)
Tidsramme: 1 year
|
1 year
|
|
EuroQoL Questioonaire (EQ-5D)
Tidsramme: 2 years
|
2 years
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NE11/9972
- 11/YH/0404 (Annen identifikator: Research Ethics Committee)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .