- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Posterior percutaneous instrumentations
|
|
Other: Traditional open surgery with pedicle screw fixation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual analogue pain (VAS) scores
Time Frame: 3 months
|
3 months
|
Visual analogue pain (VAS) scores
Time Frame: 6 months
|
6 months
|
Visual analogue pain (VAS) scores
Time Frame: 1 year
|
1 year
|
Visual analogue pain (VAS) scores
Time Frame: 2 years
|
2 years
|
Oswestry disability score
Time Frame: 3 months
|
3 months
|
Oswestry disability score
Time Frame: 6 months
|
6 months
|
Oswestry disability score
Time Frame: 1 year
|
1 year
|
Oswestry disability score
Time Frame: 2 years
|
2 years
|
EuroQoL Questioonaire (EQ-5D)
Time Frame: 3 months
|
3 months
|
EuroQoL Questioonaire (EQ-5D)
Time Frame: 6 months
|
6 months
|
EuroQoL Questioonaire (EQ-5D)
Time Frame: 1 year
|
1 year
|
EuroQoL Questioonaire (EQ-5D)
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NE11/9972
- 11/YH/0404 (Other Identifier: Research Ethics Committee)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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