Condition of Approval Study

Lumbar Spinal Stenosis Clinical Trial

— COAST  

Official title:

Treatment of Lumbar Spinal Stenosis With X-STOP® PEEK Spacer in Moderately Symptomatic Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00517751
• Other study ID #: LSS-006-COA
• Status: Terminated
• Phase: Phase 4
• First received: August 15, 2007
• Last updated: December 6, 2017
• Start date: August 2007
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 176
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Device:
• X-STOP PEEK
Placement of X-STOP PEEK in up to two levels in the lumbar spine for patients diagnosed with moderately symptomatic lumbar spinal stenosis in accordance with current labeling instructions for use.

Locations

Country	Name	City	State
United States	The Center Orthopedic & Neurosurgical Care & Research	Bend	Oregon
United States	The Kirklin Clinic - UAB Medical	Birmingham	Alabama
United States	Silicon Valley Spine Institute	Campbell	California
United States	Mayfield Clinic	Cincinnati	Ohio
United States	Colorado Neurosurgery Associates, P.C.	Denver	Colorado
United States	UpState Orthopedics	East Syracuse	New York
United States	NeuroSpine Institute	Eugene	Oregon
United States	Panaorama Orthopedics and Spine Center	Golden	Colorado
United States	Drisko, Fee & Parkins, P.C.	Kansas City	Missouri
United States	University of Kentucky, Dept of Neurosurgery	Lexington	Kentucky
United States	Pinnacle Orthopedics	Marietta	Georgia
United States	Orthopaedic Center of Southern Illinois	Mount Vernon	Illinois
United States	Yale School of Medicine, Dept. of Orthopaedics	New Haven	Connecticut
United States	Texas Back Institute	Plano, Denton, Mansfield	Texas
United States	UC Davis Spine Center	Sacramento	California
United States	Neurosurgical Associates of San Antonio	San Antonio	Texas
United States	UCLA Comprehensive Spine Center	Santa Monica	California
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	Scott & White Memorial Hospital & Scott, Sherwood & Brindley Foundation	Temple	Texas
United States	Tucson Orthopaedic Institute-East Office	Tucson	Arizona
United States	Tucson Orthopaedic Institute-Northwest Office	Tucson	Arizona
United States	George Washington University Hospital Medical Facility Associates	Washington	District of Columbia
United States	OrthopaediCare	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spine LLC

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 24 Months	The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 24 months is reported.	24 months
Other	Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 60 Months	The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 60 months is reported.	60 months
Other	Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 24 Months	The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 24 months is reported.	24 months
Other	Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 60 Months	The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 60 months is reported.	60 months
Other	Percent of Subjects Who Reported Implant-Related Adverse Events		Overall study period
Other	Percent of Subjects Who Had Any Subsequent Lumbar Spine Surgery		Overall study period
Primary	Treatment Success Rate at 24 Months	Treatment success rate is reported as the percentage of participants who met all of the following criteria: Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the Zurich Claudication Questionnaire (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 pre-operative 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	24 months
Secondary	Treatment Success Rate at 60 Months	Treatment success rate is reported as the percentage of participants who met all of the following criteria: 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 pre-operative 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	60 months
Secondary	Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ)	ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. If more than two items were missing, the SS score was considered as missing.	Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Secondary	Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ)	Success rate in SS domain of ZCQ is reported as percentage of participants who had success in SS domain of the ZCQ. The SS success was defined as clinically significant improvement by at least 0.5 point in SS score compared to preoperative baseline.	6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months
Secondary	Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ)	PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. If more than one item were missing, the PF score was considered as missing.	Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Secondary	Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ)	Success rate in PF domain of ZCQ is reported as percentage of participants who had success in PF domain of ZCQ. The PF success was defined as clinically significant improvement by at least 0.5 points in PF score compared to preoperative baseline.	6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months
Secondary	Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment	PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.	6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Secondary	Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment	Success rate in PS domain of ZCQ at post treatment is reported as the percentage of participants who had success in PS domain of ZCQ. The PS success was defined as PS score less than 2.5.	6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months
Secondary	Oswestry Disability Index (ODI) Score	ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).	Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Secondary	General Health Status -- SF-36 PCS	The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.	Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Secondary	General Health Status -- SF-36 MCS	MCS score is between 0 and 100, with higher scores denoting better quality of life.	Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Secondary	Back Pain in Numerical Rating Scales (NRS)	Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."	Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Secondary	Left Leg Pain in Numerical Rating Scales (NRS)	Left leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."	Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months
Secondary	Right Leg Pain in Numerical Rating Scales (NRS)	Right leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."	Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months