Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Post-Approval Study to Investigate The Long Term (5-Year) Survivorship of Coflex Compared to Control Fusion Study Patients
1 other identifier
interventional
322
0 countries
N/A
Brief Summary
Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2007
CompletedFirst Posted
Study publicly available on registry
September 24, 2007
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
February 27, 2019
CompletedFebruary 6, 2020
January 1, 2020
3.2 years
September 20, 2007
November 20, 2018
January 24, 2020
Conditions
Outcome Measures
Primary Outcomes (8)
Number of Subjects With Improvement of at Least 15 Points in ODI
The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI) in both treatment groups at 5 years. It will be assessed if the improvement in ODI since the pre surgery status in the coflex™ group is better than the improvement in the control group (scale 0-100 with a higher score representing increased disability).
5 years
Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation
Assessment of secondary surgical interventions, i.e., reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group. Refer to FDA guidance for complete definitions (https://www.fda.gov/RegulatoryInformation/Guidances/ucm072263.htm).
5 years
Number of Subjects With no Major Device Related Complications
Assessment of major device-related complications at 5 years
5 years
Number of Subjects With no Epidural Injection(s)
Assessment of lumbar epidural injections
5 years
Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit
No persistent new or increasing sensory or motor deficit
5 years
Number of Subjects With no Persistent New or Increasing Sensory Deficit
No persistent new or increasing sensory deficit
5 years
Number of Subjects With no Persistent New or Increasing Motor Deficit
No persistent new or increasing motor deficit
5 years
Number of Subjects With no Reoperations or Epidural (Up to Day 1825)
No reoperations, revisions, removals or supplemental fixation and no epidural injection at any lumbar level up to and including the Month 60 visit.
5 years
Secondary Outcomes (21)
Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points
5 years
Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points
5 years
Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component
5 years
Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component
5 years
Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm
5 years
- +16 more secondary outcomes
Other Outcomes (35)
Mean Rotation (F to E) in Degrees - At Level(s) of Implant
5 years
Rotation (F to E) in Degrees - Below Level of Implant
5 years
Rotation (F to E) in Degrees - Above Level of Implant
5 years
- +32 more other outcomes
Study Arms (2)
Posterolateral Fusion w/Pedicle Screws
ACTIVE COMPARATORControl: Posterolateral fusion and implantation of pedicle screws after decompression
coflex Interlaminar Technolgy
ACTIVE COMPARATORInvestigative: Implantation of coflex Interlaminar Technology after decompression
Interventions
Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain
Sponsors & Collaborators
- Paradigm Spinelead
- MCRAcollaborator
Related Publications (1)
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.
PMID: 23725394DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Fran Magee, DVM
- Organization
- Paradigm Spine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2007
First Posted
September 24, 2007
Study Start
October 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 6, 2020
Results First Posted
February 27, 2019
Record last verified: 2020-01