Ignite Creation Date:
2024-05-05 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00534092
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2007-09-20
Brief Title:
Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP
Sponsor:
Medtronic Spine LLC
Organization:
Medtronic Spinal and Biologics
Study Overview
Official Title:
Long-term Outcomes Among Patients With Lumbar Spinal Stenosis Treated With the X STOP Interspinous Process Decompression System Five-Year Follow-up of IDE Patient Cohorts
Status:
COMPLETED
Status Verified Date:
2015-03
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:
The Long-Term Outcomes Study LTOS is a multi-center longitudinal cohort study of all patients who received the X-STOP device in the Pivotal Trial Continued Access Protocol CAP or Cross-over Study COS It is designed to supplement postmarket safety and effectiveness data to be gathered in a Condition of Approval CoA study of a population of patients with moderately impaired physical function who elect to undergo X-STOP surgery
Detailed Description:
Evaluate the long term safety and effectiveness of the X-Stop interspinous process decompression system In the patients who received the X-Stop under the IDE These patients consist of two cohorts to be evaluated patients who had moderately impaired physical function prior to X-Stop implantation as determined by a baseline score 20 in the physical function PF domain of the Zurich claudication questionnaire and patients who had mildly impaired physical function prior to X-Stop surgeryas determined by a baseline score 20 in the PF domain of the Zurich claudication questionnaire ZCQ through the fifth postoperative year Clinical examination will be performed at each office visit to confirm the absence of neurological complications X-ray films APlateral views taken during the fifth postoperative year will be analyzed to confirm A maintenance of distraction and B the absence of radiological evidence of device-related complications Secondary endpoints will include mean scores from the SF-36 and incidence rates of adverse events device failures and secondary surgeries
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