At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 138 enrolled
Drug / intervention
HEALOS and Leopard Cage +1 moredevice
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 Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach
Advanced Technologies and Regenerative Medicine, LLC (ATRM)·interventional·Posted Apr 20, 2006·Updated Mar 3, 2011
In Brief
A Phase 3 clinical trial evaluating HEALOS and Leopard Cage and Leopard Cage and Autograft for Degenerative Disc Disease. Completed, enrolled 138 participants across 17 sites.
Detailed Summary
The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDegenerative Disc Disease
CountriesUnited States
CollaboratorsDePuy Spine
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedApr 2006
Primary CompletionJan 2010
TodayJul 2026
First PostedApr 20, 2006
Enrollment StartApr 1, 2006
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.2 years ago
Interventions
HEALOS and Leopard Cagedevice
Placement in interbody space
Leopard Cage and Autograftdevice
Placement in the interbody space