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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
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Metastatic Spinal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

    First Posted
    October 28, 2014
    Last Updated
    November 4, 2014
    Sponsor
    The Leeds Teaching Hospitals NHS Trust
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    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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