Status:
COMPLETED
Randomized Controlled Trial of Open Stabilisation Versus TPS
Lead Sponsor:
The Leeds Teaching Hospitals NHS Trust
Conditions:
Metastatic Spinal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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, progressiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
End Date :
August 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02284945
Start Date
August 1 2011
End Date
August 1 2014
Last Update
November 6 2014
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