NCT02284945

Randomized Controlled Trial of Open Stabilisation Versus TPS

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: The Leeds Teaching Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Metastatic Spinal Disease

Interventions

Type	Name	Description
PROCEDURE	Open fixation
PROCEDURE	Keyhole surgery

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-11-06
• Last updated: 2014-11-06