Degenerative conditions of the lumbar and cervical spine Musculoskeletal Diseases Spondylopathies
Conditions
Interventions
1. Study Arm: Anterior Approach Cervical Interbody Fusion(ACDF)
ACDF with CoRoent® Small Contoured or Small Lordotic Plus (SLP) and AttraX® Putty in the interbody space, and with NuVasive Helix ACPTM
Sponsors
NuVasive, Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Persistent arm pain unresponsive to conservative treatment for at least 6 weeks or persistent back and/or leg pain unresponsive to conservative treatment for at least 6 months, unless surgical treatment is clinically indicated sooner 2. Indicated for anterior cervical discectomy and fusion (ACDF), anterior lumbar interbody fusion (ALIF or XLIF), or posterior lumbar interbody fusion (PLIF or TLIF) at one or two contiguous motion segments (C3 to T1 in the cervical spine or L1 to S1 in the lumbar spine) 3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies 4. 18-70 years of age at the date of written informed consent 5. Able to undergo surgery based on physical exam, medical history and surgeon judgment 6. Expected to survive at least 2 years beyond surgery 7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol 8. Signed and dated informed consent form
Exclusion criteria
Exclusion criteria: 1. Mental or physical condition that would limit the ability to comply with study requirements 2. Previous failed fusion at any spinal level 3. Prior fusion procedure at operative level(s) (i.e. no revision of prior level) 4. Prior instrumented fusion at level(s) adjacent to operative level(s) 5. Systemic or local infection; active or latent 6. Diseases that significantly inhibit bone healing (e.g., osteoporosis, metabolic bone disease) 7. Treatment with pharmaceuticals interfering with calcium metabolism 8. Undergoing chemotherapy or radiation treatment 9. Chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids) 10. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested) 11. Significant general illness [e.g., human immunodeficiency virus (HIV), active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease] 12. Immunocompromised or is being treated with immunosuppressive agents 13. Pregnant, or plans to become pregnant during the study 14. A prisoner 15. Participating in another clinical study that would confound study data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The radiographic fusion rates at 12 months and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The complication rate attributable to the use of AttraX® Putty 2. The evaluation of angular displacement on flexion / extension films at the 6-, 12-, and 24-month follow-up visits 3. The evaluation of bridging bone on computerised tomography (CT) at 12- and 24-month (as required) follow-up visits 4. Preservation of interverterbal disc height over time 5. The change in American Spinal Injury Association (ASIA) score from baseline at each follow-up visit 6. The change in subject self-reported pain scores Visual Analogue Scale (VAS) from baseline at each follow-up visit 7. The change in Neck Disability Index (NDI) or Oswestry Disability Index (ODI) scores from baseline at each follow-up visit 8. The change in SF-36 scores from baseline at each follow-up visit 9. Patient satisfaction at each follow-up visit 10. The number of subjects returning to employment and the mean time of return to employment (as applicable) | — |
Countries
Germany, United Kingdom
Outcome results
None listed