Condition of Approval Study

NCT00517751 | Terminated Phase 4 Results

• 1 other identifier: LSS-006-COA
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 23

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.

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar Spinal Stenosis; X-STOP Spacer; Interspinous process decompression; Neurogenic Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

• Treatment Success Rate at 24 Months

  Treatment success rate is reported as the percentage of participants who met all of the following criteria: 1. 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 2. Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline 3. Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score \< 2.5 4. No additional surgery for lumbar stenosis performed 5. Maintenance of distraction 6. No dislodgement of the implant 7. No device-related complications

  24 months

Secondary Outcomes (13)

• Treatment Success Rate at 60 Months

  60 months

• Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ)

  Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

• Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ)

  6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months

• Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ)

  Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months

• Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ)

  6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months

Other Outcomes (6)

• Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 24 Months

  24 months

• Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 60 Months

  60 months

• Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 24 Months

  24 months

Study Arms (1)

X-STOP PEEK

EXPERIMENTAL

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

Device: X-STOP PEEK

Interventions

X-STOP PEEK 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.

X-STOP PEEK

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• has a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire
• is 50 years old or older
• 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.
• can sit for 50 minutes without pain
• can walk 50 feet or more
• 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
• 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
• has signed a patient informed consent document
• is physically and mentally willing and able or has a caregiver who can comply with the postoperative and routinely scheduled clinical and radiographic evaluations
• 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

You may not qualify if:

• has a baseline score less than or equal to 2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire
• cannot sit for 50 minutes
• cannot walk more than 50 feet
• has unremitting pain in any spinal position
• has axial back pain only without leg/buttock/groin pain
• has a fixed motor deficit
• has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction
• has severe symptomatic lumbar spinal stenosis at more than two levels
• 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)
• has an ankylosed segment at the affected level(s);
• has significant scoliosis (Cobb angle is greater than 25 degrees)
• has an acute fracture of the spinous process or pars interarticularis
• has sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and /or hips
• 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
• has Paget's disease at the involved segment(s) or metastasis to the vertebrae

Sponsors & Collaborators

• Medtronic Spine LLC: lead

Study Sites (23)

The Kirklin Clinic - UAB Medical

Birmingham, Alabama, 35249, United States

Location

Tucson Orthopaedic Institute-East Office

Tucson, Arizona, 85712, United States

Location

Tucson Orthopaedic Institute-Northwest Office

Tucson, Arizona, 85741, United States

Location

Silicon Valley Spine Institute

Campbell, California, 95008, United States

Location

UC Davis Spine Center

Sacramento, California, 95818, United States

Location

UCLA Comprehensive Spine Center

Santa Monica, California, 90404, United States

Location

Colorado Neurosurgery Associates, P.C.

Denver, Colorado, 80220, United States

Location

Panaorama Orthopedics and Spine Center

Golden, Colorado, 80401, United States

Location

Yale School of Medicine, Dept. of Orthopaedics

New Haven, Connecticut, 06520, United States

Location

George Washington University Hospital Medical Facility Associates

Washington D.C., District of Columbia, 20037, United States

Location

Pinnacle Orthopedics

Marietta, Georgia, 30060, United States

Location

Orthopaedic Center of Southern Illinois

Mount Vernon, Illinois, 62864, United States

Location

University of Kentucky, Dept of Neurosurgery

Lexington, Kentucky, 40536-0298, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Drisko, Fee & Parkins, P.C.

Kansas City, Missouri, 64116, United States

Location

UpState Orthopedics

East Syracuse, New York, 13057, United States

Location

Mayfield Clinic

Cincinnati, Ohio, 45219, United States

Location

The Center Orthopedic & Neurosurgical Care & Research

Bend, Oregon, 97701, United States

Location

NeuroSpine Institute

Eugene, Oregon, 97401, United States

Location

OrthopaediCare

Willow Grove, Pennsylvania, 19090, United States

Location

Texas Back Institute

Plano, Denton, Mansfield, Texas, 75093, 76208, 76063, United States

Location

Neurosurgical Associates of San Antonio

San Antonio, Texas, 78258, United States

Location

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

Temple, Texas, 76508, United States

Location

Related Publications (3)

• 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.

  PMID: 15959362 BACKGROUND

• 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.

  PMID: 17176013 BACKGROUND

• 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.

  PMID: 16826002 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Limitations and Caveats

Study strengths include collection of 5-year data and radiographic examinations. Study weaknesses include single-arm design and early termination of the study without reaching the desired sample size.

Results Point of Contact

• Title: Clinical Department
• Organization: Medtronic Spinal and biologics

msbkclinicalresearch@medtronic.com

1800-876-3133

Study Officials

• Jim Malcolm, MD

  Pinnacle Orthopedics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 17, 2007
• Study Start: August 1, 2007
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 2, 2018
• Results First Posted: February 12, 2016

Record last verified: 2016-01

Locations

US (23)