A new study published in Bone & Joint Research reveals the effectiveness of Orthofix's Cervical-Stim device.
The study included patients with a risk factor that could lead to cervical spine fusion failure or who had undergone a two- or three-level arthrodesis. Researchers leveraged Orthofix's FDA investigational device exemption premarket approval study with 323 patients as well as a retrospective cohort study with 274 patients.
Here are three takeaways.
1. The study investigated the impact of pulsed electromagnetic field treatment on patients with an increased risk of pseudoarthrosis following anterior cervical discectomy and fusion.
2. Researchers discovered PEMF stimulation significantly boosted the fusion rate compared to the control group following ACDF. The study assessed the patients, at risk of pseudoarthrosis, at six months and 12 months.
3. The FDA approved the Orthofix Cervical-Stim device as an adjunct to cervical spinal fusions.
"This data is important as it builds on the findings of the original Orthofix PMA study that proved the safety and effectiveness of PEMF stimulation with the Cervical-Stim device," said James Ryaby, PhD, Orthofix chief scientific officer. "The results published in Bone & Joint Research support the use of PEMF treatment for high-risk ACDF patients and should help surgeons feel confident when prescribing this therapy."