Early Cases of Single-Level Cervical Total Disc Replacement in Japan-Short-Term Safety Assessment Using Registry...

Area of Science:

• Spine surgery
• Orthopedic surgery
• Biomaterials and implants

Background:

• Total disc replacement (TDR) with Mobi-C® and Prestige LP® was approved in Japan in 2017.
• A Japanese TDR guideline and registry system were established to ensure effective surgical outcomes and monitor safety.
• This study evaluated the short-term safety of single-level TDR during its early post-approval period in Japan.

Purpose of the Study:

• To assess complications associated with single-level TDR using a nationwide registry.
• To evaluate the short-term safety and complication rates of TDR in the early post-marketing surveillance period.
• To analyze perioperative and 2-year postoperative complication and reoperation rates.

Main Methods:

• Analysis of data from a Japanese nationwide registry of single-level TDR procedures.
• Inclusion of patient characteristics, surgical details, complications, and reoperations.
• Evaluation of complication and reoperation rates during hospitalization and up to 2 years post-discharge.

Main Results:

• 332 patients were enrolled; 271 completed 2-year follow-up.
• Perioperative complications included hematoma (1.1%) and airway obstruction (0.4%), with one reoperation.
• Postoperative complications (up to 2 years) occurred in 7.4% of patients, including neurological symptom recurrence and implant issues.

Conclusions:

• Single-level TDR demonstrated relatively low overall complication and reoperation rates.
• The study suggests TDR achieves favorable outcomes with acceptable complication rates when used appropriately.
• Findings support the short-term safety of TDR for single-level indications in Japan.