Viewing Study NCT02284945



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Last Modification Date: 2024-10-26 @ 11:33 AM
Study NCT ID: NCT02284945
Status: COMPLETED
Last Update Posted: 2014-11-06
First Post: 2014-10-28

Brief Title: Randomized Controlled Trial of Open Stabilisation Versus TPS
Sponsor: The Leeds Teaching Hospitals NHS Trust
Organization: The Leeds Teaching Hospitals NHS Trust

Study Overview

Official Title: A Randomized Controlled Trial Comparing Open Spinal Stabilisation and Percutaneous Solution TPS Surgery in Patients With Metastatic Spinal Disease
Status: COMPLETED
Status Verified Date: 2014-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 bladderbowel 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: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
11YH0404 OTHER Research Ethics Committee None