At a glance
ClinicalIndex Comparison RecordN/ACompleted· 224 enrolled
Drug / intervention
INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Platedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pivotal Clinical Investigation of INFUSE® Bone Graft With a PEEK Interbody Spacer and an Anterior Cervical Plate in Patients With Cervical Degenerative Disc Disease at a Single Level.
In Brief
A clinical study evaluating INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate for Degenerative Disc Disease. Completed, enrolled 224 participants across 16 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical degenerative disc disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDegenerative Disc Disease
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedJun 2007
Primary CompletionDec 2011
Study CompletionJun 2012
TodayJul 2026
First PostedJun 12, 2007
Enrollment StartJun 1, 2007
Primary CompletionDec 1, 2011
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 19.1 years ago
Interventions
INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Platedevice
All patients enrolled in this study will receive the investigational device.