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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Posterior percutaneous instrumentations
|
|
|
Otro: Traditional open surgery with pedicle screw fixation
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Visual analogue pain (VAS) scores
Periodo de tiempo: 3 months
|
3 months
|
|
Visual analogue pain (VAS) scores
Periodo de tiempo: 6 months
|
6 months
|
|
Visual analogue pain (VAS) scores
Periodo de tiempo: 1 year
|
1 year
|
|
Visual analogue pain (VAS) scores
Periodo de tiempo: 2 years
|
2 years
|
|
Oswestry disability score
Periodo de tiempo: 3 months
|
3 months
|
|
Oswestry disability score
Periodo de tiempo: 6 months
|
6 months
|
|
Oswestry disability score
Periodo de tiempo: 1 year
|
1 year
|
|
Oswestry disability score
Periodo de tiempo: 2 years
|
2 years
|
|
EuroQoL Questioonaire (EQ-5D)
Periodo de tiempo: 3 months
|
3 months
|
|
EuroQoL Questioonaire (EQ-5D)
Periodo de tiempo: 6 months
|
6 months
|
|
EuroQoL Questioonaire (EQ-5D)
Periodo de tiempo: 1 year
|
1 year
|
|
EuroQoL Questioonaire (EQ-5D)
Periodo de tiempo: 2 years
|
2 years
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NE11/9972
- 11/YH/0404 (Otro identificador: Research Ethics Committee)
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