Clinical trial NCT00534092: Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Spinal Stenosis
Keywords: Lumbar Spinal Stenosis
X STOP
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2007-09-24
Enrollment: 69
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received implants and completed participation in the Pivotal, CAP, or COS studies and has the implant intact and is willing and able to provide consent and return to the clinic for evaluation or complete study questionnaires.

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 \>2.0 in the physical function (PF) domain of the Zurich claudication questionnaire), and patients who had mildly impaired physical function prior to X-Stop surgery(as determined by a baseline score \<=2.0 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 (AP/lateral 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.

Eligibility criteria: Inclusion Criteria:

A patient will be admitted into the LTOS program if he/she meets all of the following inclusion criteria:

1. Completed participation in the Pivotal Trial, CAP, or COS and has the X STOP implant(s) intact at the time of LTOS enrollment; OR is an active CAP/COS participant, has the X STOP implant(s) intact, and has not completed a 24-month follow-up visit in his/her CAP/COS study.
2. Is willing and able to provide Informed Consent
3. Is willing and able to return to the clinic for a clinical evaluation or complete study questionnaires without a clinic visit.

Exclusion Criteria:

A patient will not be admitted into the LTOS program if he/she meets any of the following exclusion criteria:

1. Participated in the Pivotal Trial as part of the X STOP group, but the device has been removed.
2. Participated in the CAP or COS programs, but the device has been removed.

Primary outcomes:
measure: Treatment Success Rates (At ≥ 5 Years)
timeFrame: 3+ years following first 2 years post-X-STOP implant through IDE study
Secondary outcomes:
measure: Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)
timeFrame: Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study
measure: Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)
timeFrame: 3+ years following first 2 years post-X-STOP implant through IDE study
measure: Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years)
timeFrame: Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study
Other outcomes:
measure: Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study
timeFrame: 3+ years following first 2 years post-X-STOP implant through IDE study
measure: Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study
timeFrame: 3+ years following first 2 years post-X-STOP implant through IDE study
Locations:
city: San Francisco
country: United States
facility: St. Mary's Spine Center
state: California
city: Scarborough
country: United States
facility: Neurological & Spine Associates
state: Maine
city: Timonium
country: United States
facility: Greater Baltimore Spine Care
state: Maryland
city: Norfolk
country: United States
facility: Neurological Specialist
state: Virginia
city: Madison
country: United States
facility: University Hospital
state: Wisconsin
Study officials:
References:
citation: Hsu KY, Zucherman JF, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Cauthen JC, Ozuna RM. Quality of life of lumbar stenosis-treated patients in whom the X STOP interspinous device was implanted. J Neurosurg Spine. 2006 Dec;5(6):500-7. doi: 10.3171/spi.2006.5.6.500.
citation: Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Puccio ST, Cauthen JC, Ozuna RM. A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results. Spine (Phila Pa 1976). 2005 Jun 15;30(12):1351-8. doi: 10.1097/01.brs.0000166618.42749.d1.