Clinical trial NCT00517751: Condition of Approval Study
Official title: Treatment of Lumbar Spinal Stenosis With X-STOP® PEEK Spacer in Moderately Symptomatic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Lumbar Spinal Stenosis
Keywords: Lumbar Spinal Stenosis
X-STOP Spacer
Interspinous process decompression
Neurogenic Intermittent Claudication
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2007-08-17
Enrollment: 176
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (i.e., 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 (i.e., 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, and/or 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. Clinical/neurological 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.

Eligibility criteria: Inclusion Criteria:

1. has a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire
2. is 50 years old or older
3. has leg/buttock/groin pain with or without back pain NOTE: Leg/buttock/groin pain must be completely relieved when flexed such as when sitting in a chair. If back pain is also present, it must be partially relieved when flexed.
4. can sit for 50 minutes without pain
5. can walk 50 feet or more
6. has a confirmed diagnosis of neurogenic intermittent claudication secondary to lumbar spinal stenosis, with X-Ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess and/or central canal narrowing
7. has completed at least six months of conservative care therapy which may include but is not limited to physical therapy, bracing, systemic or injected medications
8. has signed a patient informed consent document
9. is physically and mentally willing and able or has a caregiver who can comply with the postoperative and routinely scheduled clinical and radiographic evaluations
10. lives in the immediate area and has no plans to relocate to another geographic area before completion of the study or lives outside the immediate area and will comply with the scheduled postoperative visits with a prearranged and designated physician

Exclusion Criteria:

1. has a baseline score less than or equal to 2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire
2. cannot sit for 50 minutes
3. cannot walk more than 50 feet
4. has unremitting pain in any spinal position
5. has axial back pain only without leg/buttock/groin pain
6. has a fixed motor deficit
7. has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction
8. has severe symptomatic lumbar spinal stenosis at more than two levels
9. has significant instability of the lumbar spine, e.g., isthmic spondylolisthesis or degenerative spondylolisthesis greater than grade 1 (on a scale of 1 to 4)
10. has an ankylosed segment at the affected level(s);
11. has significant scoliosis (Cobb angle is greater than 25 degrees)
12. has an acute fracture of the spinous process or pars interarticularis
13. has sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and /or hips
14. has severe osteoporosis of the spine or hip, defined as bone mineral density (BMD) in the spine or hip more than 2.5 SD below the mean of adult normals in the presence of one or more fragility fractures
15. has Paget's disease at the involved segment(s) or metastasis to the vertebrae
16. has had any surgery of the lumbar spine
17. has significant peripheral neuropathy demonstrated by nerve conduction velocity tests
18. has acute denervation secondary to radiculopathy, as shown by EMG
19. has significant peripheral vascular disease characterized by diminished dorsalis pedus or tibial pulses
20. has extreme obesity as defined by a Body Mass Index (BMI) greater than 40 kg/m2
21. has an active systemic infection or infection localized to the site of implantation
22. has an active systemic disease such as AIDS, HIV, hepatitis, etc.
23. has a medical condition that may interfere with postoperative management and follow-up, or may result in patient death prior to study completion (e.g., Alzheimer's disease, unstable cardiac disease, active malignancy)
24. has a recent history of narcotic abuse (i.e., within last 3 years)
25. has a known allergy to titanium,titanium alloy, or polyetheretherketone
26. is immunologically suppressed, or has received or is receiving steroids at any dose daily for more than one month within the last 12 months
27. is currently involved in a study of another investigational product that may affect the outcome of this study
28. is pregnant or planning to become pregnant during the study period
29. cannot undergo MRI or tolerate closed MRI scanning.

Primary outcomes:
measure: Treatment Success Rate at 24 Months
timeFrame: 24 months
Secondary outcomes:
measure: Treatment Success Rate at 60 Months
timeFrame: 60 months
measure: Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ)
timeFrame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
measure: Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ)
timeFrame: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months
measure: Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ)
timeFrame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
measure: Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ)
timeFrame: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months
measure: Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment
timeFrame: 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
measure: Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment
timeFrame: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months
measure: Oswestry Disability Index (ODI) Score
timeFrame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
measure: General Health Status -- SF-36 PCS
timeFrame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
measure: General Health Status -- SF-36 MCS
timeFrame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
measure: Back Pain in Numerical Rating Scales (NRS)
timeFrame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
measure: Left Leg Pain in Numerical Rating Scales (NRS)
timeFrame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
measure: Right Leg Pain in Numerical Rating Scales (NRS)
timeFrame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Other outcomes:
measure: Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 24 Months
timeFrame: 24 months
measure: Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 60 Months
timeFrame: 60 months
measure: Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 24 Months
timeFrame: 24 months
measure: Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 60 Months
timeFrame: 60 months
measure: Percent of Subjects Who Reported Implant-Related Adverse Events
timeFrame: Overall study period
measure: Percent of Subjects Who Had Any Subsequent Lumbar Spine Surgery
timeFrame: Overall study period
Locations:
city: Birmingham
country: United States
facility: The Kirklin Clinic - UAB Medical
state: Alabama
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute-East Office
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute-Northwest Office
state: Arizona
city: Campbell
country: United States
facility: Silicon Valley Spine Institute
state: California
city: Sacramento
country: United States
facility: UC Davis Spine Center
state: California
city: Santa Monica
country: United States
facility: UCLA Comprehensive Spine Center
state: California
city: Denver
country: United States
facility: Colorado Neurosurgery Associates, P.C.
state: Colorado
city: Golden
country: United States
facility: Panaorama Orthopedics and Spine Center
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine, Dept. of Orthopaedics
state: Connecticut
city: Washington
country: United States
facility: George Washington University Hospital Medical Facility Associates
state: District of Columbia
city: Marietta
country: United States
facility: Pinnacle Orthopedics
state: Georgia
city: Mount Vernon
country: United States
facility: Orthopaedic Center of Southern Illinois
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky, Dept of Neurosurgery
state: Kentucky
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Kansas City
country: United States
facility: Drisko, Fee & Parkins, P.C.
state: Missouri
city: East Syracuse
country: United States
facility: UpState Orthopedics
state: New York
city: Cincinnati
country: United States
facility: Mayfield Clinic
state: Ohio
city: Bend
country: United States
facility: The Center Orthopedic & Neurosurgical Care & Research
state: Oregon
city: Eugene
country: United States
facility: NeuroSpine Institute
state: Oregon
city: Willow Grove
country: United States
facility: OrthopaediCare
state: Pennsylvania
city: Plano, Denton, Mansfield
country: United States
facility: Texas Back Institute
state: Texas
city: San Antonio
country: United States
facility: Neurosurgical Associates of San Antonio
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital & Scott, Sherwood & Brindley Foundation
state: Texas
Study officials:
affiliation: Pinnacle Orthopedics
name: Jim Malcolm, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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: Kondrashov DG, Hannibal M, Hsu KY, Zucherman JF. Interspinous process decompression with the X-STOP device for lumbar spinal stenosis: a 4-year follow-up study. J Spinal Disord Tech. 2006 Jul;19(5):323-7. doi: 10.1097/01.bsd.0000211294.67508.3b.