INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial (ACDF)

• Rate of Overall Success [ Time Frame: 24 months post-operation ] [ Designated as safety issue: Yes ]

  Rate of overall success is reported as the percentage of participants who met all of the following criteria:

  1. fusion at the treated level;
  2. pain/disability (Neck Disability Index) success;
  3. neurological status success;
  4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated;"
  5. no additional surgical procedure classified as a "failure."
  
  

• Success Rate of Fusion [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]

  Success Rate of Fusion is reported as percent of participants who met the following fusion criteria:

  1. Evidence of bridging bone. This is based on the evidence of a continuous bony connection from the superior vertebral body to the inferior vertebral body in at least one of the following areas: lateral, anterior, posterior and/or through the PEEK spacer.
  2. No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface.
  3. No evidence of motion as defined by ≤ 4º of angular motion (based on flexion-extension lateral plain radiographs).
  
  
• Success Rate of Neck Disability Index [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
  Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.
  
  
• Success Rate of Neurological Status [ Time Frame: 24 months post-operation ] [ Designated as safety issue: Yes ]
  Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.
  
  
• Neck Pain Success Rate [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
  Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0.
  
  
• Arm Pain Success Rate [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
  Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0.
  
  
• Success Rate of SF-36 PCS [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
  Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rate of SF-36 PCS was defined as: Post Score - Pre Score >= 0.
  
  
• Success Rate of SF-36 MCS [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
  Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 MCS were defined as: Post Score - Pre Score >= 0.
  
  
• Operative Time [ Time Frame: Time of operation, approximately 1.5 hrs. ] [ Designated as safety issue: No ]
  Operative time was recorded from skin incision to wound closure.
  
  
• Blood Loss [ Time Frame: During the time of operation, approximately 1.5 hours. ] [ Designated as safety issue: No ]
  
• Hospital Stay [ Time Frame: During the time of hospital stay, average of 1 day. ] [ Designated as safety issue: No ]
  
• Number of Patients Who Had Secondary Surgeries at the Index Level [ Time Frame: 24 months post-operation ] [ Designated as safety issue: Yes ]
  Secondary surgical procedures at the index level included revisions, removal, supplemental fixation and reoperations.
  
  

• Neck Disability Index Score [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
  The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
  
  
• Neck Pain Score [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
  Numerical rating scales are used to evaluate neck pain intensity and frequency. Patients rate their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients record their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score is the sum of pain intensity and frequency scores.
  
  
• Arm Pain Score [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
  Numerical rating scales are used to evaluate arm pain intensity and frequency. Patients rate their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients record their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score will be the sum of pain intensity and frequency scores.
  
  
• General Health Status -- SF-36 PCS [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
  The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.
  
  
• General Health Status -- SF-36 MCS [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
  The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS is between 0 and 100, with higher scores denoting better quality of life.
  
  
• Ossification in the Region of Target Level [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
  Ossification in the region of target level is reported as the percentage of the patients who had ossification in the region of the target level. The region of target level included the index level, the superior and inferior adjacent disc spaces, and the superior and inferior adjacent vertebral bodies.
  
  

This pivotal clinical trial is being conducted to evaluate the safety and effectiveness of INFUSE® Bone Graft with the PEEK Interbody Spacer and Anterior Cervical Plate in patients with symptomatic cervical degenerative disc disease (DDD). The implant under investigation in this clinical trial is INFUSE® Bone Graft, the PEEK Interbody Spacer, and Anterior Cervical Plate. The device will be implanted using an anterior surgical approach. Safety and effectiveness data for patients in this study will be compared to that of historical controls. Historical control data will be taken from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).