The BioFlex System as a Dynamic Stabilization Device: Does It Preserve Lumbar Motion?.

Abstract

OBJECTIVE: This study examines whether functional motion is present at one or more years after Bioflex System placement. BioFlex System is a flexible rod system which has been used to preserve motion at the area of implantation. There has not been a scientific study showing how much motion is preserved after implantation. METHODS: A total of 12 consecutive patients underwent posterior dynamic stabilization using the BioFlex System. Six patients were treated using a L3-4-5 construct and other six patients using a L4-5-S1 construct. Follow-up ranged from 12 to 33 months and standing neutral lateral, extension, flexion and posteroanterior (PA) radiographs were obtained at 3, 6, 9, and 12 months and at more than 12 months postoperatively. Range of motion (ROM), whole lumbar lordosis, and ROMs of motion segments from L2 to S1 were determined. RESULTS: Patients with a L3-4-5 construct demonstrated a decrease in mean ROM for whole lumbar decreased from 40.08 to 30.77. Mean ROM for L3-4 (6.12 to 2.20) and L4-5 (6.55 to 1.67) also decreased after one year. Patients with a L4-5-S1 construct demonstrated L4-5 (8.75 to 2.70) and L5-S1 (9.97 to 3.25) decrease of mean ROM at one year postoperatively. Lumbar lordosis was preserved at both L3-4-5 and L4-5-S1 constructs. Clinical results showed significant improvements in both study groups. CONCLUSION: The present study provides preliminary information regarding the BioFlex motion preservation system. We conclude that the BioFlex System preserves functional motion to some degree at instrumented levels. However, although total lumbar lordosis was preserved, ROMs at implantation segments were lower than preoperative values.