Condition of Approval Study

NCT ID: NCT00517751

Last Updated: 2018-01-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2015-04-30

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.

Conditions

Lumbar Spinal Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

X-STOP PEEK

In this arm, patients will undergo X-STOP PEEK surgery.

Group Type: EXPERIMENTAL

X-STOP PEEK

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spine LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jim Malcolm, MD

Role: PRINCIPAL_INVESTIGATOR

Pinnacle Orthopedics

Locations

The Kirklin Clinic - UAB Medical

Birmingham, Alabama, United States

Tucson Orthopaedic Institute-East Office

Tucson, Arizona, United States

Tucson Orthopaedic Institute-Northwest Office

Tucson, Arizona, United States

Silicon Valley Spine Institute

Campbell, California, United States

UC Davis Spine Center

Sacramento, California, United States

UCLA Comprehensive Spine Center

Santa Monica, California, United States

Colorado Neurosurgery Associates, P.C.

Denver, Colorado, United States

Panaorama Orthopedics and Spine Center

Golden, Colorado, United States

Yale School of Medicine, Dept. of Orthopaedics

New Haven, Connecticut, United States

George Washington University Hospital Medical Facility Associates

Washington D.C., District of Columbia, United States

Pinnacle Orthopedics

Marietta, Georgia, United States

Orthopaedic Center of Southern Illinois

Mount Vernon, Illinois, United States

University of Kentucky, Dept of Neurosurgery

Lexington, Kentucky, United States

Spine Institute of Louisiana

Shreveport, Louisiana, United States

Drisko, Fee & Parkins, P.C.

Kansas City, Missouri, United States

UpState Orthopedics

East Syracuse, New York, United States

Mayfield Clinic

Cincinnati, Ohio, United States

The Center Orthopedic & Neurosurgical Care & Research

Bend, Oregon, United States

NeuroSpine Institute

Eugene, Oregon, United States

OrthopaediCare

Willow Grove, Pennsylvania, United States

Texas Back Institute

Plano, Denton, Mansfield, Texas, United States

Neurosurgical Associates of San Antonio

San Antonio, Texas, United States

Scott & White Memorial Hospital & Scott, Sherwood & Brindley Foundation

Temple, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15959362 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17176013 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16826002 (View on PubMed)

Other Identifiers

LSS-006-COA

Identifier Type: -

Identifier Source: org_study_id