Randomized Controlled Trial of Open Stabilisation Versus TPS
Primary Purpose
Metastatic Spinal Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Open fixation
Keyhole surgery
Sponsored by
About this trial
This is an interventional trial for Metastatic Spinal Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Posterior percutaneous instrumentations
Traditional open surgery with pedicle screw fixation
Arm Description
Outcomes
Primary Outcome Measures
Visual analogue pain (VAS) scores
Visual analogue pain (VAS) scores
Visual analogue pain (VAS) scores
Visual analogue pain (VAS) scores
Oswestry disability score
Oswestry disability score
Oswestry disability score
Oswestry disability score
EuroQoL Questioonaire (EQ-5D)
EuroQoL Questioonaire (EQ-5D)
EuroQoL Questioonaire (EQ-5D)
EuroQoL Questioonaire (EQ-5D)
Secondary Outcome Measures
Full Information
NCT ID
NCT02284945
First Posted
October 28, 2014
Last Updated
November 4, 2014
Sponsor
The Leeds Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02284945
Brief Title
Randomized Controlled Trial of Open Stabilisation Versus TPS
Official Title
A Randomized Controlled Trial Comparing Open Spinal Stabilisation and Percutaneous Solution (TPS) Surgery in Patients With Metastatic Spinal Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Spinal Disease
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Posterior percutaneous instrumentations
Arm Type
Experimental
Arm Title
Traditional open surgery with pedicle screw fixation
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Open fixation
Intervention Type
Procedure
Intervention Name(s)
Keyhole surgery
Primary Outcome Measure Information:
Title
Visual analogue pain (VAS) scores
Time Frame
3 months
Title
Visual analogue pain (VAS) scores
Time Frame
6 months
Title
Visual analogue pain (VAS) scores
Time Frame
1 year
Title
Visual analogue pain (VAS) scores
Time Frame
2 years
Title
Oswestry disability score
Time Frame
3 months
Title
Oswestry disability score
Time Frame
6 months
Title
Oswestry disability score
Time Frame
1 year
Title
Oswestry disability score
Time Frame
2 years
Title
EuroQoL Questioonaire (EQ-5D)
Time Frame
3 months
Title
EuroQoL Questioonaire (EQ-5D)
Time Frame
6 months
Title
EuroQoL Questioonaire (EQ-5D)
Time Frame
1 year
Title
EuroQoL Questioonaire (EQ-5D)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Randomized Controlled Trial of Open Stabilisation Versus TPS
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