Randomized Controlled Trial of Open Stabilisation Versus TPS

November 4, 2014 updated by: The Leeds Teaching Hospitals NHS Trust

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

Completed

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Estimate)

November 6, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

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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