Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517751
Status:
TERMINATED
Last Update Posted:
2018-01-02
First Post:
2007-08-15
Brief Title:
Condition of Approval Study
Sponsor:
Medtronic Spine LLC
Organization:
Medtronic Spinal and Biologics
Study Overview
Official Title:
Treatment of Lumbar Spinal Stenosis With X-STOP PEEK Spacer in Moderately Symptomatic Patients
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to Medtronics voluntary withdrawal of PMA P040001 for X-STOP systems post-approval study costs outweighed business benefits for marketing X-STOP in US
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COAST
Brief Summary:
This prospective multicenter longitudinal five-year study of X-STOP PEEK usage in LSS patients is designed to supplement pre-market safety and effectiveness data with information on longer-term device performance in a population of patients with moderately impaired physical function at preoperative baseline ie an indicated population who elect to undergo X STOP PEEK surgery
Detailed Description:
This prospective multicenter longitudinal five-year study of X-STOP PEEK implant usage in LSS patients is designed to supplement pre-market safety and effectiveness data with information on longer-term device performance in a population of patients with moderately impaired physical function at preoperative baseline ie an indicated population who elect to undergo X-STOP PEEK surgery This post-approval study will enroll 240 patients at up to 8 clinical sites where all participating spine surgeons have completed a company-sponsored physician training program The clinical sites recruited to participate in this study comprise a geographically diverse mix of academic referral andor community based sites
Safety and effectiveness data will be assessed at baseline and annually through five 5 years postoperatively Office visits will be scheduled preoperatively and at 6 weeks 1 2 3 4 and 5 years postoperatively Clinicalneurological and radiographic examination will be performed during each office visit A baseline patient history including medication usage will be taken and concomitant medications will be recorded at each postoperative follow-up visit In addition patients will be asked to complete the following questionnaires prior to consultation with their physicians or their staff Zurich Claudication Questionnaire ZCQ Oswestry Disability Index ODI Numeric Rating Scale NRS and SF-36 Health Survey At the 2- 3- 4- and 5-year office visit patients will also be asked two questions assessing the value of surgery and the overall improvement in the quality of life postoperatively
The primary study endpoint in this study is treatment success Secondary endpoints will include scores from the SF-36 ODI and NRS as well as incidence rates of adverse events device failures and secondary surgeries
Safety and effectiveness data will be assessed at baseline and annually through five 5 years postoperatively Office visits will be scheduled preoperatively and at 6 weeks 1 2 3 4 and 5 years postoperatively Clinicalneurological and radiographic examination will be performed during each office visit A baseline patient history including medication usage will be taken and concomitant medications will be recorded at each postoperative follow-up visit In addition patients will be asked to complete the following questionnaires prior to consultation with their physicians or their staff Zurich Claudication Questionnaire ZCQ Oswestry Disability Index ODI Numeric Rating Scale NRS and SF-36 Health Survey At the 2- 3- 4- and 5-year office visit patients will also be asked two questions assessing the value of surgery and the overall improvement in the quality of life postoperatively
The primary study endpoint in this study is treatment success Secondary endpoints will include scores from the SF-36 ODI and NRS as well as 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