Condition of Approval Study (COAST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Medtronic Spine LLC
Sponsor:
Information provided by (Responsible Party):
Medtronic Spine LLC
ClinicalTrials.gov Identifier:
NCT00517751
First received: August 15, 2007
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Lumbar Spinal Stenosis
Device: X-STOP PEEK
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Lumbar Spinal Stenosis With X-STOP® PEEK Spacer in Moderately Symptomatic Patients

Resource links provided by NLM:


Further study details as provided by Medtronic Spine LLC:

Primary Outcome Measures:
  • Treatment response rates equivalent to overall success reported in the IDE pivotal trial as measured by improvement in ZCQ scores, no additional surgery for LSS, maintenance of distraction, no dislodgement of the implant or device related complications. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoints: SF-36, ODI, and NRS scores, Adverse event rate,device failures, MRI evaluation of adjacent levels and secondary surgeries. [ Time Frame: Two to Five years ] [ Designated as safety issue: No ]
  • Treatment response rates at 5 years as measured by ZCQ, no additional LSS surgery, maintenance of distraction, no dislodgement or device complications. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: August 2007
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: X-STOP PEEK
In this arm, patients will undergo X-STOP PEEK surgery.
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.

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517751

Contacts
Contact: Clinical Department 1800-876-3133 ext 6068 msbkclinicalresearch@medtronic.com

  Hide Study Locations
Locations
United States, Alabama
The Kirklin Clinic - UAB Medical Recruiting
Birmingham, Alabama, United States, 35249
Contact: Meredith Owens, NP    205-481-7938    mhowens@uabmc.edu   
Principal Investigator: Melissa Chambers, MD         
United States, Arizona
Tucson Orthopaedic Institute-Northwest Office Recruiting
Tucson, Arizona, United States, 85741
Contact: Crystal Placencia    520-784-6430    cplacencia@tucsonortho.com   
Principal Investigator: Stephen Hanks, MD         
Sub-Investigator: Steven Zeiller, MD         
Tucson Orthopaedic Institute-East Office Recruiting
Tucson, Arizona, United States, 85712
Contact: Crystal Placencia    520-784-6430    cplacencia@tucsonortho.com   
Principal Investigator: Gerard Jeong, MD         
Sub-Investigator: Jeffrey Barron, MD         
Sub-Investigator: Stephen Curtin, MD         
United States, California
Tower Orthopaedics & Neurosurgical Spine Institute Withdrawn
Beverly Hills, California, United States, 90211
Silicon Valley Spine Institute Recruiting
Campbell, California, United States, 95008
Contact: Julia Coe    408-376-3300    julia@svspine.com   
Principal Investigator: Jeffrey Coe, MD         
UC Davis Spine Center Active, not recruiting
Sacramento, California, United States, 95818
UCLA Comprehensive Spine Center Terminated
Santa Monica, California, United States, 90404
United States, Colorado
Colorado Neurosurgery Associates, P.C. Recruiting
Denver, Colorado, United States, 80220
Contact: Janae Marshall    303-333-8740    denverneurosurg@gmail.com   
Principal Investigator: Stephen Shogan, MD         
Durango Orthopedics & Spine Colorado Withdrawn
Durango, Colorado, United States, 81301
Panaorama Orthopedics and Spine Center Completed
Golden, Colorado, United States, 80401
United States, Connecticut
Yale School of Medicine, Dept. of Orthopaedics Active, not recruiting
New Haven, Connecticut, United States, 06520
United States, District of Columbia
George Washington University Hospital Medical Facility Associates Recruiting
Washington, District of Columbia, United States, 20037
Contact: Stacy Tam    202-741-2602    stam@mfa.gwu.edu   
Principal Investigator: Warren Yu, MD         
Sub-Investigator: Joseph O'Brien, MD         
United States, Georgia
Pinnacle Orthopedics Recruiting
Marietta, Georgia, United States, 30060
Contact: Lu Hill    770-429-7790    lu.hill@pinnacle-ortho.com   
Principal Investigator: Jim Malcolm, MD         
United States, Illinois
Orthopaedic Center of Southern Illinois Recruiting
Mt. Vernon, Illinois, United States, 62864
Contact: Laura Pestka, RN    618-242-3778    Laurap@ocosi.org   
Principal Investigator: Don A Kovalsky, MD         
United States, Kentucky
University of Kentucky, Dept of Neurosurgery Recruiting
Lexington, Kentucky, United States, 40536-0298
Contact: Mary Faulkner    859-218-5006    mffaul2@email.uky.edu   
Principal Investigator: Philip Tibbs, MD         
Sub-Investigator: Karin Swartz, MD         
United States, Louisiana
Spine Institute of Louisiana Recruiting
Shreveport, Louisiana, United States, 71101
Contact: Norma Rivera-Phillips    318-629-5519    nrivera@louisianaspine.org   
Principal Investigator: Pierce Nunley, MD         
Sub-Investigator: Phillip Utter, MD         
Sub-Investigator: David Cavanaugh, MD         
Sub-Investigator: Eubulus Kerr, MD         
United States, Maryland
Brain and Spine Specialist, PA Withdrawn
Bel Air, Maryland, United States, 21014
United States, Missouri
Drisko, Fee & Parkins, P.C. Recruiting
Kansas City, Missouri, United States, 64116
Contact: Carol Kane    816-561-3003    ckane@vrgkc.com   
Contact: Janel Chilson    816-561-3003    jchilson@dfportho.com   
Principal Investigator: Robert Drisko, MD         
Sub-Investigator: Kathleen Stegeman, MD         
United States, New York
University of Buffalo Neurosurgery Withdrawn
Buffalo, New York, United States, 14203
UpState Orthopedics Recruiting
East Syracuse, New York, United States, 13057
Contact: Tina Craig    315-464-8618    craigt@upstate.edu   
Principal Investigator: William Lavelle, MD         
Sub-Investigator: Richard Tallarico, MD         
Sub-Investigator: Mike Sun, MD         
Sub-Investigator: Ian Madom, MD         
United States, Ohio
Mayfield Clinic Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Becky Reinert    513-558-5539    gibsonrk@ucmail.uc.edu   
Principal Investigator: Christopher McPherson, MD         
United States, Oregon
The Center Orthopedic & Neurosurgical Care & Research Recruiting
Bend, Oregon, United States, 97701
Contact: Meredith Dawson    541-330-8653    mdawson@thecenteroregon.com   
Principal Investigator: Brad Ward, MD         
NeuroSpine Institute Recruiting
Eugene, Oregon, United States, 97401
Contact: Shawn Potts    541-284-0530    spotts@neurospinellc.com   
Principal Investigator: Scott Kitchel, MD         
Sub-Investigator: Christopher Noonan, MD         
Sub-Investigator: Carmina Angeles, MD         
Sub-Investigator: Christopher Miller, MD         
United States, Pennsylvania
OrthopaediCare Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contact: Barbara Finn    267-913-3121    bfinn@paortho.com   
Principal Investigator: Guy Lee, MD         
Sub-Investigator: Victor Hsu, MD         
Sub-Investigator: Michael Gratch, MD         
United States, Tennessee
Center for Sports Medicine & Orthopaedics aka Chattanooga Orthopaedic Center Withdrawn
Chattanooga, Tennessee, United States, 37404
United States, Texas
Texas Back Institute Recruiting
Plano, Denton, Mansfield, Texas, United States, 75093, 76208, 76063
Contact: Shannon Rusch    972-608-5181    srusch@texasback.com   
Principal Investigator: Michael Duffy, MD         
Sub-Investigator: W. Dan Bradley, MD         
Sub-Investigator: Jessica Shellock, MD         
Neurosurgical Associates of San Antonio Terminated
San Antonio, Texas, United States, 78258
Scott & White Memorial Hospital & Scott, Sherwood & Brindley Foundation Recruiting
Temple, Texas, United States, 76508
Contact: Evelyn Kile    254-724-9292    ekile@sw.org   
Principal Investigator: Christopher Chaput, MD         
Sub-Investigator: Mark Rahm, MD         
Sponsors and Collaborators
Medtronic Spine LLC
Investigators
Principal Investigator: Jim Malcolm, MD Pinnacle Orthopedics
  More Information

Publications:
Responsible Party: Medtronic Spine LLC
ClinicalTrials.gov Identifier: NCT00517751     History of Changes
Other Study ID Numbers: LSS-006-COA
Study First Received: August 15, 2007
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Spine LLC:
Lumbar Spinal Stenosis
X-STOP Spacer
Interspinous process decompression
Neurogenic Intermittent Claudication

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014