Outcomes of Degenerative Disc Disease Patients Treated With an Anterior-Only Fusion Using InQu Bone Graft
Status unconfirmed
Conditions studied: Degenerative Disc Disease
In brief
The purpose of this study is to report the radiographic, clinical, and functional outcomes of a consecutive series of patients diagnosed with single or bilateral degenerative disc disease between L4 and S1, that have been treated with an anterior lumbar interbody fusion (ALIF), anterior only surgical approach, and InQu Bone Graft Extender and Substitute for bony fusion and instrumentation. Patients that decide to undergo an Anterior Lumbar Interbody Fusion (ALIF) surgery \[a surgical procedure that joins two or more lumbar vertebrae (small bones of the spine) together into one solid bony structure by approaching the spine through the abdomen (front of the body) and placing a bone graft in between the vertebral bodies where the disc usually lies\], are invited to participate in an orthopaedic research study. This study will compare patients that have been treated with an anterior lumbar interbody fusion using InQu Bone Graft Extender \& Substitute to published data for a stand alone spinal fusion surgery, where InFuse bone graft is placed between the transverse processes \[small bony projections off the right and left side of each bone in your spine\] of the affected vertebrae. X-rays, daily activities, and how patients are doing will be evaluated at specific time points during this study. The hypothesis of this study is that patients diagnosed with degenerative disc disease treated with an anterior lumbar interbody fusion, anterior only surgical approach (incision through the abdomen), using InQu Bone Graft Extender and Substitute and instrumented fixation have comparable radiographic (x-rays), functional (daily activities), and clinical (how the patient is doing) outcomes when compared to published data for use of InFuse in stand-alone fusion.
Key facts
- Study ID
- NCT01746212
- Run by
- Kansas Joint and Spine Institute
- People needed
- 60
- Starts
- 2012-12-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2012-12-10
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Kansas Joint and Spine Institute — Wichita, Kansas, United States (enrolling)
- National Center of Innovation for Biomaterials in Orthopaedic Research — Wichita, Kansas, United States
Full record on ClinicalTrials.gov
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