An article published in the Journal of Neurosurgery: Spine examines the seven-year follow-up for patients who received the Prestige artificial disc in a prospective randomized controlled clinical trial.
The article includes 32 investigational sites with 541 patients with single-level cervical disc disease with radiculopathy. The patients were randomized into two treatment groups. They either received anterior cervical discectomy and arthroplasty with the Prestige disc or anterior cervical discectomy and fusion. There were 395 patients who completed the seven-year follow-up.
The researchers found:
1. There were significant improvements for both patient groups at 1.5 months which were also sustained at seven years after surgery.
2. Average Neck Disability Index improvements were 38.2 at 60 months and 37.5 at 84 months in the investigational group. The control group had an NDI score at 33.8 at 60 months and 31.9 at 84 months. The difference between the two groups was significant.
3. Neurological status maintenance and improvement rates were significantly higher in the investigational group, at 92.2 percent at 60 months and 88.2 percent at 84 months. In the control group, neurological status maintenance and improvement rates were 85.7 percent at 60 months and 79.7 percent at 84 months.
4. The implant effectively maintained average angular motion of 6.67 degrees at 60 months and 6.75 degrees at 84 months postoperatively.
5. The investigational group had lower cumulative rates for surgery at the index level when compared with the control group based on the life-table method.
6. There were statistical differences between the investigational and control groups for the revision rate and supplemental fixation surgical procedures.
7. Additional surgical procedures involving adjacent levels were lower in the investigational group than in the control group. "Cervical disc arthroplasty has the potential for preserving motion at the operated level while providing biomechanical stability and global neck mobility and may result in a reduction in adjacent-segment degeneration," concluded the study authors.
More articles on spine surgery:
35 spine surgeons under 40 to know
100 times spine surgeons made the headlines this year
5 robotic spine surgery systems sold in the United States for 3Q