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| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P040001 / PAS002 |
| Date Original Protocol Accepted |
11/21/2005
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| Date Current Protocol Accepted |
10/24/2014
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| Study Name |
COAST Study
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| Device Name |
X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This Medtronic Spine LLC-sponsored, prospective, multicenter longitudinal five-year study of X-STOPPK 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 (i.e., an indicated population) who elect to undergo X-STOPPK surgery.
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| Study Population |
The study population was comprised of patients aged 50 years and older who have lumbar spinal stenosis, suffers symptoms of neurogenic intermittent claudication, have moderately impaired physical function, and are able to relieve their symptoms when they bend forward or flex their spines. This device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis (with X-Ray, MRI, and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess and/or central canal narrowing). The X-STOP is indicated for those patients with moderately impaired physical function who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of nonoperative treatment. The X-STOP may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
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| Sample Size |
The sample size required within the protocol is 240 patients.
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| Key Study Endpoints |
This study was designed primarily to evaluate long-term treatment response to the X-STOPPK implant in LSS patients with moderately impaired physical function at baseline. Treatment success in an individual patient (i.e., a responder) was defined by seven separate criteria at the two-year postoperative evaluation, as follows:
Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the ZCQ compared to preoperative baseline
Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to preoperative baseline
Patient satisfaction with treatment (defined as a Patient Satisfaction [PS] score <2.5)
No additional surgery for lumbar stenosis performed
Maintenance of distraction
No dislodgement of the implant
No device-related complications
Sustained treatment success in a responder was defined as continued success at the five-year postoperative evaluation as defined above.
Secondary endpoints included scores from the SF-36, ODI, and NRS, as well as incidence rates of adverse events, device failures, and secondary surgeries.
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| Follow-up Visits and Length of Follow-up |
Safety and effectiveness data was assessed at baseline and annually through five (5) years postoperatively. Office visits were scheduled preoperatively, and at 6 weeks and, 1, 2, 3, 4, and 5 years postoperatively. Clinical/neurological and radiographic examination was performed during each office visit. A baseline patient history (including medication usage) was taken, and concomitant medications were recorded at each postoperative follow-up visit. In addition, patients were asked to complete the following questionnaires prior to consultation with their physicians or their staff at each postoperative visit: 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 were also asked two questions assessing the value of surgery and the overall improvement in the quality of life postoperatively.
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| Interim or Final Data Summary |
| Interim Results |
The mean change in baseline symptom severity score was 0.97 at 6 post-operative weeks and 1.01 at 12 post-operative months. Five study subjects experienced device migration and 2 subjects suffered spinous process fracture.
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| Actual Number of Patients Enrolled |
These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.
162 patients were enrolled.
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| Actual Number of Sites Enrolled |
These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.
20 sites participated in enrollment.
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| Patient Follow-up Rate |
These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.
The follow-up rate of expected subjects is 91.53% and 91.67% at the 24-month and 60-month visit, respectively. The attrition rate due to death, lost to follow-up and withdrawal is 5.56% and 27.16% at the 24-month and 60-month visit, respectively.
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| Final Safety Findings |
These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.
Adverse Events (AEs) Summary:
Through August 15, 2014, a total of 814 adverse events were reported by 132 (81.5%) patients. The most common category of AEs was musculoskeletal and connective tissue disorders, reported by 88 (54.3%) patients and the most commonly reported adverse event was back pain, reported by 36 (22.2%) patients. Within this set of AEs, thirty-two events were reported for 18 (11.1%) patients to be implant-related while 51 events reported in 27 (16.7%) patients were classified as X-STOP procedure-related. The most frequently reported implant-related AE was device removal reported in 10 (6.2%) patients. The most frequently reported procedure-related AEs were incisional site pain in 7 (4.3%) patients, and spinal fracture in 6 (3.7%) patients.
Serious Adverse Events (SAEs) Summary:
Through August 15, 2014, a total of 210 serious adverse events have been reported by 65 (40.1%) patients. Within this set of SAEs, 26 events were reported for 15 (9.3%) patients to be implant-related while five events reported in 3 (1.9%) patients were classified as X-STOP procedure-related.
Subsequent Lumbar Surgery
There were 39 secondary surgery forms completed in thirty-two (19.8%) patients with 28 (17.3%) patients reporting X-STOP removal.
Success Rates
Overall success rates for the study participants were observed as follows:
12 months, 44.8%; 24 months, 30.9%; and 60 months, 24.2%.
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| Final Effect Findings |
These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.
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| Study Strengths & Weaknesses |
These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.
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| Recommendations for Labeling Changes |
These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.
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