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OpenTrials
Completed

NCT Number: NCT02284945

Randomized Controlled Trial of Open Stabilisation Versus TPS

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.

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Key information

Conditions

Metastatic Spinal Disease Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open fixation

Procedure

Keyhole surgery

Procedure

Primary outcomes

  1. Visual analogue pain (VAS) scores

    Time frame: 3 months

  2. Visual analogue pain (VAS) scores

    Time frame: 6 months

  3. Visual analogue pain (VAS) scores

    Time frame: 1 year

  4. Visual analogue pain (VAS) scores

    Time frame: 2 years

  5. Oswestry disability score

    Time frame: 3 months

  6. Oswestry disability score

    Time frame: 6 months

  7. Oswestry disability score

    Time frame: 1 year

  8. Oswestry disability score

    Time frame: 2 years

  9. EuroQoL Questioonaire (EQ-5D)

    Time frame: 3 months

  10. EuroQoL Questioonaire (EQ-5D)

    Time frame: 6 months

  11. EuroQoL Questioonaire (EQ-5D)

    Time frame: 1 year

  12. EuroQoL Questioonaire (EQ-5D)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Open Spinal Stabilisation and Percutaneous Solution (TPS) Surgery in Patients With Metastatic Spinal Disease.

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 6, 2014
Registry last updated
Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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