Randomized Controlled Trial of Open Stabilisation Versus TPS

Not Applicable

Completed

• Conditions: Metastatic Spinal Disease
• Interventions: Procedure: Open fixation; Procedure: Keyhole surgery

• Registration Number: NCT02284945
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted: 2014-10-28
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-04
• Last Update Submitted: 2014-11-04
• Study First Posted: 2014-11-06
• Last Update Posted: 2014-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Traditional open surgery with pedicle screw fixation	Open fixation	-
Posterior percutaneous instrumentations	Keyhole surgery	-

Primary Outcome Measures

Name	Time	Method
Oswestry disability score	2 years
EuroQoL Questioonaire (EQ-5D)	2 years
Visual analogue pain (VAS) scores	2 years