Intervertebral Disc Degeneration Clinical Trial
Official title:
Post Market Comparison of nanOss Cervical Interbody Fusion System to C-Plus Interbody Fusion Device With Autograft
This is a post-market, prospective, randomized clinical investigation to evaluate the performance of the nanOss Cervical Interbody Fusion (IBF) device with nanOss Bioactive Bone Void Filler for the treatment of cervical disc disease. A secondary objective is to compare the performance of the nanOss Cervical IBF Device and nanOss Bioactive Bone Void Filler with the performance of the C-Plus PEEK IBF Device with autograft. This study will enroll 40 patients at one (1) site. After subjects have signed an informed consent, they will be randomly assigned to either the nanOss Cervical IBF device arm or the C-Plus PEEK IBF Device. Patients will complete the preoperative visit and examinations. Patients will be evaluated at discharge, six (6) weeks, three (3) months, six (6) months, and twelve (12) months. Patients will be evaluated at twenty-four (24) months post-operatively if they have not demonstrated fusion at the 12 month time point.
The nanOss Cervical Interbody Fusion Device is CE-marked for single level intervertebral body
fusion from C3 to T1 for the treatment of cervical disc disease. The nanOss IBF device is
designed to be used as one device per level, with graft material and supplemental fixation.
nanOss BABone Void Filler is a resorbable porous calcium phosphate bone void filler for use
as a bone graft substitute or bone void filler. It is CE marked for use as a bone void filler
in the spine, and it is to be re-hydrated with Bone Marrow Aspirate (BMA) alone, or a mixture
of the patient's BMA and autograft.
The C-Plus PEEK IBF Device is indicated for use in skeletally mature adults at one level in
the cervical spine, from C3 to T1, for the treatment of cervical disc disease. The device is
to be used in patients who have had six weeks of non-operative treatment. Autogenous bone
graft is placed within the central cavity of the C-Plus PEEK IBF Device.
The SlimFuse Cervical Plate System components are titanium alloy plates and screws designed
to temporarily provide resistance to flexion, extension, lateral bending and axial rotation
with strength and stiffness in the cervical spine (C2-C7) in order to promote cervical
fusion. The anterior approach should be used when implanting the SlimFuse Cervical Plate
System.
The primary goal of this study is to evaluate the outcomes between nanOss Cervical IBF Device
and C-Plus PEEK IBF Device. The primary endpoint will be objectively determined via x-rays
and CT scan to assess fusion. Secondary endpoints will include subjective patient scores for
neck and arm pain and quality of life along with analysis of the proportion of patients who
experience a treatment failure.
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