Spinal Fusion Clinical Trial
Official title:
Prospective Follow-up Study of CeSPACE XP - Titanium Coated PEEK Cages - for the Treatment of Degenerative Cervical Disc Disease
Prospective Follow-up study of CeSPACE XP coated PEEK cages for the treatment of degenerative cervical disc disease
Anterior cervical discectomy and fusion (ACDF) has been accepted as the standard procedure
for the treatment of myelopathy and radiculopathy in the cervical spine. A tricortical iliac
crest bone graft is the traditional inter-body fusion material that can show perfect bony
fusion and maintain the patency of the neuroforamen. However, donor site complications were
reported in fusion with an iliac bone graft, such as subcutaneous hematomas, infections, and
chronic wound pain.
Currently, the titanium cage and polyetheretherketone (PEEK) cage are the two most common
cages in clinical practice. The ideal cage should lead to a high fusion rate and prevent
complications, such as subsidence and loss of correction.
Even though a titanium cage can provide long-term stabilization, increase lordosis, and
increase foramina height compared with the iliac bone graft, some inferior clinical outcomes
appeared in clinical practice. Loss of correction is a major complication of subsidence that
may eventually affect cervical spinal function after the operation.
A modulus of elasticity close to cortical bone might contribute to advantages in stress
distribution and load sharing, which can contribute to a lower subsidence rate and, thus,
better clinical results, making PEEK cages more welcomed by surgeons.
It is supposed, that in the cervical fusion procedure, a porous coating of a PEEK cage will
lead to favourable results. Therefore, the present study intends to show these results, in a
larger patient cohort who received such a coated cervical cage.
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