Clinical trial NCT00534235: Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Official title: Post-Approval Study to Investigate The Long Term (5-Year) Survivorship of Coflex Compared to Control Fusion Study Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis
Lead sponsor: Paradigm Spine
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2007-09-24
Enrollment: 322
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis

Detailed description: The primary objective of this post-approval study is to examine the long-term survivorship of the coflex®. The coflex® Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).


Primary outcomes:
measure: Number of Subjects With Improvement of at Least 15 Points in ODI
timeFrame: 5 years
measure: Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation
timeFrame: 5 years
measure: Number of Subjects With no Major Device Related Complications
timeFrame: 5 years
measure: Number of Subjects With no Epidural Injection(s)
timeFrame: 5 years
measure: Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit
timeFrame: 5 years
measure: Number of Subjects With no Persistent New or Increasing Sensory Deficit
timeFrame: 5 years
measure: Number of Subjects With no Persistent New or Increasing Motor Deficit
timeFrame: 5 years
measure: Number of Subjects With no Reoperations or Epidural (Up to Day 1825)
timeFrame: 5 years
Secondary outcomes:
measure: Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points
timeFrame: 5 years
measure: Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points
timeFrame: 5 years
measure: Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component
timeFrame: 5 years
measure: Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component
timeFrame: 5 years
measure: Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm
timeFrame: 5 years
measure: Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm
timeFrame: 5 years
measure: Mean Oswestry Disability Index (ODI) Score
timeFrame: 5 years
measure: Mean Visual Analog Scale Back Pain Score
timeFrame: 5 years
measure: Mean Visual Analog Scale Leg (Worse) Pain Score
timeFrame: 5 years
measure: Mean Visual Analog Scale (VAS) Leg (Right) Pain Score
timeFrame: 5 years
measure: Mean Visual Analog Scale (VAS) Leg (Left) Pain Score
timeFrame: 5 years
measure: Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm
timeFrame: 5 years
measure: Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm
timeFrame: 5 years
measure: Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score
timeFrame: 5 years
measure: Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score
timeFrame: 5 years
measure: Mean Short Form-12 Physical Component Score
timeFrame: 5 years
measure: Mean Short Form-12 Mental Component Score
timeFrame: 5 years
measure: Patient Survey: Satisfaction
timeFrame: 5 years
measure: Patient Survey: Recommendation of Treatment
timeFrame: 5 years
measure: Pain Management: Class II Narcotics Usage by Device Group
timeFrame: 5 years
measure: Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group
timeFrame: 5 years
Other outcomes:
measure: Mean Rotation (F to E) in Degrees - At Level(s) of Implant
timeFrame: 5 years
measure: Rotation (F to E) in Degrees - Below Level of Implant
timeFrame: 5 years
measure: Rotation (F to E) in Degrees - Above Level of Implant
timeFrame: 5 years
measure: Translation (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Translation (mm) - Below Level of Implant
timeFrame: 5 years
measure: Translation (mm) - Above Level of Implant
timeFrame: 5 years
measure: Anterior Disc Height (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Posterior Disc Height (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Translation (F to E) in Percent (%) - At Level(s) of Implant
timeFrame: 5 years
measure: Translation (F to E) in Percent (%) - Below Level of Implant
timeFrame: 5 years
measure: Translation (F to E) in Percent (%) - Above Level of Implant
timeFrame: 5 years
measure: Average Disc Height (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Pre-Op Anterior Disc Height (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Pre-Op Posterior Disc Height (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Pre-Op Average Disc Height (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Post-Op Anterior Disc Height (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Post-Op Posterior Disc Height (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Post-Op Average Disc Height (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Disc Angle in Degrees - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Pre-Op Disc Angle in Degrees - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Post-Op Disc Angle in Degrees - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Post-Op Spondylolisthesis (%) - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Pre-Op Spondylolisthesis (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Foraminal Height (X-ray) (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Pre-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Change From Post-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant
timeFrame: 5 years
measure: Bony Bridging
timeFrame: 5 years
measure: Heterotopic Ossification
timeFrame: 5 years
measure: Fusion Status
timeFrame: 5 years
measure: Interface Remodeling - At Level(s) of Implant
timeFrame: 5 years
measure: Device Condition (Coflex Arm)
timeFrame: 5 years
measure: Device Condition (Fusion Control)
timeFrame: 5 years
measure: Device Mobility
timeFrame: 5 years
Locations:
Study officials:
References:
citation: Davis R, Auerbach JD, Bae H, Errico TJ. Can low-grade spondylolisthesis be effectively treated by either coflex interlaminar stabilization or laminectomy and posterior spinal fusion? Two-year clinical and radiographic results from the randomized, prospective, multicenter US investigational device exemption trial: clinical article. J Neurosurg Spine. 2013 Aug;19(2):174-84. doi: 10.3171/2013.4.SPINE12636. Epub 2013 May 31.