Orthopedics This Week | February 16, 2016 | Page 7
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ORTHOPEDICS THIS WEEK
VOLUME 12, ISSUE 6 | FEBRUARY 16, 2016
patient safety was not compromised.
All adverse events were independently
reviewed and adjudicated by a Clinical
Events Committee (CEC), with their
decision binding on the study sponsor. All radiographs were analyzed by
an independent core lab (Medical Metrics, Inc.).
All patients were re-examined at 6
weeks, 3 months, 6 months, 12 months,
18 months, 24 months and, now, 60
months postoperatively.
Patients were evaluated for Oswestry
Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), SF-12,
back and leg pain (via visual analog
scale (VAS)), and neurological assessment at preoperative visit and at all
postoperative visits. Radiographic evaluation was performed at all time points.
Adverse events and complications were
recorded at all visits.
duced similar results—but with most
measures at most time points, Coflex
patients did better than fusion patients.
Now, the 5-Year Follow-Up Data
At five years:
Two tables at the end of this section will
provide more details and the study itself
is available here http://www.paradigmspine.com/content/abstract-archive.
For all patient derived parameters, the
researchers found a statistically significant improvement for patients treated
with Coflex through the five-year followup period. At five years, more Coflex
treated patients reported pain improvement of at least 20mm in VAS leg pain
than fusion patients and over 80% at
least 15 point improvement in ODI.
By all patient derived parameters, the
two treatments (Coflex and fusion) pro-
• More Coflex patients at all followup time points achieved at least
a 15 point improvement in ODI
(80% vs 76%) and at least a 20mm
VAS leg pain (80.0% vs 77%)
and VAS back pain improvement
(83.9% vs 75.5%) as compared to
the fusion group.
• 50% of the Coflex patients and
44% of the fusion patients met the
FDA’s clinical success composite
endpoint.
• The FDA required that the Coflex
investigators use a Bayesian statistical comparison between the
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