Metastatic Spinal Disease Clinical Trial
Official title:
A Randomized Controlled Trial Comparing Open Spinal Stabilisation and Percutaneous Solution (TPS) Surgery in Patients With Metastatic Spinal Disease.
| Verified date | November 2014 |
| Source | The Leeds Teaching Hospitals NHS Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Health Research Authority: UK |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
N/A
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| The Leeds Teaching Hospitals NHS Trust |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visual analogue pain (VAS) scores | 3 months | ||
| Primary | Visual analogue pain (VAS) scores | 6 months | ||
| Primary | Visual analogue pain (VAS) scores | 1 year | ||
| Primary | Visual analogue pain (VAS) scores | 2 years | ||
| Primary | Oswestry disability score | 3 months | ||
| Primary | Oswestry disability score | 6 months | ||
| Primary | Oswestry disability score | 1 year | ||
| Primary | Oswestry disability score | 2 years | ||
| Primary | EuroQoL Questioonaire (EQ-5D) | 3 months | ||
| Primary | EuroQoL Questioonaire (EQ-5D) | 6 months | ||
| Primary | EuroQoL Questioonaire (EQ-5D) | 1 year | ||
| Primary | EuroQoL Questioonaire (EQ-5D) | 2 years |