Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440856
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2007-02-23
Brief Title:
Presentation of Lumbar Disc and Reduction of Symptoms
Sponsor:
St Georges University of London
Organization:
St Georges University of London
Study Overview
Official Title:
Reduction in Leg and Back Pain Following Lumbar Microdiscetomy in Those Shown the Removed Disc Fragments After the Operation a Double Blind Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2008-05
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:
POLDAROS
Brief Summary:
The trial aims to assess the hypothesis that presentation of the disc material to the patient following a lumbar microdiscectomy would positively influence the improvement in their leg and back symptoms
Detailed Description:
Objective The trial aims to assess the hypothesis that presentation of removed material to the patient following a lumbar microdiscectomy would positively influence the improvement in their radiculopathic and degenerative symptoms
Design Data will be collected prospectively Patient allocation to treatment groups will be by simple randomization using a computer generated sequence of random numbers Trial participants will be blinded as to the trial hypothesis and investigators blinded to patient allocation
Setting Patients will all be treated in a single secondary care unit
Participants All adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc over a six month period will be considered for entry into the trial Exclusion criteria inability to give verbal consent age less than 18 previous spinal surgery emergency discectomies patients having spinal fusions and those with no radiculopathic symptoms
Intervention Patients allocated to the experimental arm will be given the removed disc fragments to keep once they have recovered from anaesthesia Those in the control arm will not be shown disc fragments best available treatment
Main outcome measure The degree of improvement in radiculopathic and degenerative symptoms reported by the patient at 2-3 months after surgery
Design Data will be collected prospectively Patient allocation to treatment groups will be by simple randomization using a computer generated sequence of random numbers Trial participants will be blinded as to the trial hypothesis and investigators blinded to patient allocation
Setting Patients will all be treated in a single secondary care unit
Participants All adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc over a six month period will be considered for entry into the trial Exclusion criteria inability to give verbal consent age less than 18 previous spinal surgery emergency discectomies patients having spinal fusions and those with no radiculopathic symptoms
Intervention Patients allocated to the experimental arm will be given the removed disc fragments to keep once they have recovered from anaesthesia Those in the control arm will not be shown disc fragments best available treatment
Main outcome measure The degree of improvement in radiculopathic and degenerative symptoms reported by the patient at 2-3 months after surgery
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