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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nanOss | Active Comparator | nanOss Cervical IBF System with nanOss BA Bone Void Filler |
|
| C-Plus | Active Comparator | C-Plus PEEK IBF Device with autograft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nanOss | Device | nanOss Cervical Interbody Fusion Device with nanOss BA bone void filler. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients demonstrating fusion at 12 months post-operatively | Fusion is defined as the presence of bridging bone between adjacent endplates of the involved motion segment, AND ≤ 2º total angular motion from flexion to extension, AND < 1.25 mm translational motion. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Scores on the Neck Disability Index Questionnaire | 12 months | |
| Pain on the Visual Analog Scale | 12 months | |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Peuskens, MD | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost Limburg | Genk | 3600 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22305868 | Background | Zhao Z, Jiang D, Ou Y, Tang K, Luo X, Quan Z. A hollow cylindrical nano-hydroxyapatite/polyamide composite strut for cervical reconstruction after cervical corpectomy. J Clin Neurosci. 2012 Apr;19(4):536-40. doi: 10.1016/j.jocn.2011.05.043. Epub 2012 Feb 3. | |
| 19893716 | Background | Kim SC, Kang SW, Kim SH, Cho KH, Kim SH. Clinical and radiological outcomes of anterior cervical interbody fusion using hydroxyapatite spacer. J Korean Neurosurg Soc. 2009 Oct;46(4):300-4. doi: 10.3340/jkns.2009.46.4.300. Epub 2009 Oct 31. |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| C-Plus | Device | C-Plus PEEK IBF Device with autograft |
|
|
Serious device related adverse events. |
| 12 months |
| Score on the EQ-5D Health Outcomes Survey | 12 months |
| Disc Height in millimetres | 12 months |
| Device Migration in millimetres | 12 months |
| Device Subsidence in millimetres | 12 months |
| Score on the RAND 36 item questionnaire | 12 months |
| Proportion of patients with subsequent surgical intervention | 12 months |
| 19769500 | Background | Ryken TC, Heary RF, Matz PG, Anderson PA, Groff MW, Holly LT, Kaiser MG, Mummaneni PV, Choudhri TF, Vresilovic EJ, Resnick DK; Joint Section on Disorders of the Spine and Peripheral Nerves of the American Association of Neurological Surgeons and Congress of Neurological Surgeons. Techniques for cervical interbody grafting. J Neurosurg Spine. 2009 Aug;11(2):203-20. doi: 10.3171/2009.2.SPINE08723. |