Spinal Deformity Clinical Trial
Official title:
A Randomized Controlled Trial of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion
The purpose of this study is to demonstrate the non-inferiority of AttraX® Putty as a bone graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar spine, in terms of efficacy and safety.
Spinal fusion, a surgical procedure frequently used for many spinal conditions requiring
stabilization of the vertebral column, is currently performed by using large amounts of
autologous bone graft or autograft. A substitute for this patient own bone would eliminate
the graft harvesting morbidity that is currently one of the main disadvantages. Recently, a
promising synthetic graft substitute has been developed that has shown favorable results in
pre-clinical studies. This product is AttraX® Putty (CE-557130), a bioresorbable tricalcium
phosphate (TCP), mixed with a fast resorbing polymer carrier to improve surgical handling.
The aim of the current study is to clinically investigate AttraX® Putty as an alternative to
autologous bone graft in adult patients qualified for instrumented posterolateral fusion of
the thoracolumbar spine (T10-S1).
The study design is a patient and observer blinded, controlled, randomized, multi-center
clinical trial with intra-patient comparisons. This means that each patient is it owns
control. According to a randomization scheme, one side of the spine will be grafted with
AttraX® Putty the other side receives bone harvest from the iliac crest, which is currently
the gold standard.
The primary outcomes of this study are the posterior spinal fusion rate after one year (based
on CT-scans), and potential serious adverse events related with AttraX® Putty. Secondary
outcomes are the resorption characteristics during the first year, volume of bridging bone
mass after one year, evaluation of iliac crest pain, correlation of the posterior fusion rate
to the presence of interbody fusion after one year and the posterior spinal fusion rate after
two years.
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