N/A
Completed N=322
Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Source: ClinicalTrials.gov NCT00534235 ↗Enrolled (actual)
322
Serious AEs
53.7%
Results posted
Feb 2019
Primary outcomePrimary: Number of Subjects With Improvement of at Least 15 Points in ODI — 41; 101 Participants
Summary
Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Improvement of at Least 15 Points in ODI |
41; 101 | — |
| PRIMARY Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation |
87; 179 | — |
| PRIMARY Number of Subjects With no Major Device Related Complications |
100; 212 | — |
| PRIMARY Number of Subjects With no Epidural Injection(s) |
84; 177 | — |
| PRIMARY Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit |
70; 135 | — |
| PRIMARY Number of Subjects With no Persistent New or Increasing Sensory Deficit |
72; 137 | — |
| PRIMARY Number of Subjects With no Persistent New or Increasing Motor Deficit |
72; 144 | — |
| PRIMARY Number of Subjects With no Reoperations or Epidural (Up to Day 1825) |
71; 149 | — |
| SECONDARY Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points |
40; 100 | — |
| SECONDARY Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points |
38; 98 | — |
| SECONDARY Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component |
34; 93 | — |
| SECONDARY Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component |
31; 72 | — |
| SECONDARY Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm |
40; 104 | — |
| SECONDARY Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm |
41; 99 | — |
| SECONDARY Mean Oswestry Disability Index (ODI) Score |
26.1; 24.5 | — |
| SECONDARY Mean Visual Analog Scale Back Pain Score |
29.0; 25.4 | — |
| SECONDARY Mean Visual Analog Scale Leg (Worse) Pain Score |
25.2; 22.8 | — |
| SECONDARY Mean Visual Analog Scale (VAS) Leg (Right) Pain Score |
16.0; 14.9 | — |
| SECONDARY Mean Visual Analog Scale (VAS) Leg (Left) Pain Score |
17.0; 18.4 | — |
| SECONDARY Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm |
36; 90 | — |
| SECONDARY Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm |
37; 78 | — |
| SECONDARY Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score |
2.17; 2.08 | — |
| SECONDARY Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score |
1.81; 1.67 | — |
| SECONDARY Mean Short Form-12 Physical Component Score |
42.1; 42.1 | — |
| SECONDARY Mean Short Form-12 Mental Component Score |
54.8; 54.1 | — |
| SECONDARY Patient Survey: Satisfaction |
72; 151 | — |
| SECONDARY Patient Survey: Recommendation of Treatment |
70; 145 | — |
| SECONDARY Pain Management: Class II Narcotics Usage by Device Group |
17; 32 | — |
| SECONDARY Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group |
24; 55 | — |
Data sourced from ClinicalTrials.gov (NCT00534235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.