Clinical experience with the new artificial cervical PCM (Cervitech) disc

Area of Science:

• Orthopedic Surgery
• Spinal Fusion Alternatives
• Biomedical Engineering

Background:

• Cervical disc arthroplasty is an alternative to spinal fusion for treating cervical disc disease.
• Evaluating the safety and efficacy of early cervical disc arthroplasty devices is crucial.
• Pilot studies provide essential data for refining surgical techniques and device designs.

Purpose of the Study:

• To assess the clinical outcomes and radiographic results of cervical disc arthroplasty.
• To evaluate patient-reported outcomes using validated pain and disability scales.
• To determine the incidence of device-related complications in a pilot cohort.

Main Methods:

• A pilot study involving 53 patients who received 82 cervical disc arthroplasties between December 2002 and October 2003.
• Clinical outcomes were measured using the Visual Analog Scale (VAS) for pain and the Neck Disability Index (NDI).
• Radiographic assessments included static and dynamic imaging, alongside the Treatment Intensity Gradient Test (TIGT).

Main Results:

• Significant improvements were observed across all evaluated scales (VAS, NDI, TIGT) postoperatively.
• Ninety percent of patients achieved good or excellent results by one month, maintained at three months (Odom's criteria).
• One instance of device migration (4 mm) was noted at three months and remained stable.

Conclusions:

• Cervical disc arthroplasty demonstrated significant improvements in pain and function in this pilot study.
• The procedure yielded high rates of good to excellent patient outcomes.
• Further investigation into long-term outcomes and device performance is warranted.