Three-year Follow-up of the First 70 Arthroplasties Using the Flexible Cervical Implant: Clinical Outcomes and Lessons Learned"

Introduction: Cervical disc arthroplasty has emerged as a viable alternative to spinal fusion in the management of symptomatic degenerative cervical disc disease. The Flexible Cervical Implant (FCI) is a one-piece implant made for additive manufacture, was designed to provide stability while preserving physiological motion at the operated segment, potentially reducing adjacent segment degeneration. This prospective study evaluates the clinical outcomes and safety profile of the FCI in 70 arthroplasties performed in 65 patients over a three-year period, with a focus on pain relief, functional improvement, and any complications.

Methods: A cohort of 65 patients (35 males, 30 females) underwent cervical arthroplasty with the FCI across 70 segments. Patients were evaluated preoperatively and at postoperative intervals of six months, one year, two years, and three years. Clinical outcomes were assessed using the Visual Analog Scale (VAS) for pain, the 36-Item Short Form Health Survey (SF-36), the Japanese Orthopaedic Association (JOA) scale, and the Neck Disability Index (NDI). The majority of patients presented with significant cervicobrachialgia, predominantly on the right side, and some with mild to moderate myelopathy. One patient, who had a prior unsuccessful surgery at an incorrect level in another facility, required reoperation due to a minor purulent drainage, which was managed successfully in another clinic.

Results: Preoperative assessments revealed high VAS scores indicating severe cervicobrachial pain. SF-36 scores reflected poor physical function and health-related quality of life, while the JOA and NDI scores demonstrated significant functional impairment. In the immediate postoperative period, all patients reported complete relief of brachialgia. No neurological complications were reported, and no additional complications were observed aside from the one reoperation mentioned.

Conclusion : This three-year follow-up of the FCI demonstrates its efficacy in relieving cervicobrachial pain, improving functional outcomes, and maintaining stability without compromising physiological motion in the cervical spine. The study highlights the FCI’s potential to offer lasting relief and functional restoration for patients with cervical disc disease.