Evaluation of pain reduction and height restoration post vertebral augmentation using a polyether ether ketone (PEEK) polymer implant for the treatment of split (Magerl A2) vertebral fractures: a prospective, long-term, non-randomized study

ObjectivesThe purposes of the study were to evaluate the safety and long-term efficacy of augmented vertebroplasty using a polyether ether ketone (PEEK) implant, for the treatment of lumbar or thoracic vertebral fractures (A2 according to the Magerl's AO classification) and to analyze pain reduction, height restoration, and complications during a 2-year follow-up period.MethodsProspective non-randomized evaluation was performed for 21 painful split vertebral fractures (20 patients, 14 females, 6 males; mean age 72.8010.991) treated with percutaneous vertebral augmentation using a PEEK device, under fluoroscopic guidance. Pain before the procedure and after 6, 12, and 24months was evaluated using a numeric visual scale (NVS) questionnaire. Imaging was performed by CT and X-rays. The minimum craniocaudal diameter at the level of the fracture and the maximum craniocaudal diameter at the middle of the fractured vertebra were measured. Statistical analysis was performed to evaluate pain decrease and height restoration.ResultsSuccessful implant positioning was achieved in all cases. No major clinical complications were observed. Comparing the mean pain scores at baseline (8.691.138) and the first day after the treatment (1.191.424), there was a decrease of 7.50 NVS units (p<0.001). Minimum and maximum vertebral body heights were increased after the procedure 56.58% and 13.7% respectively (p<0.001). Both pain relief and height restoration remained statistically significant (p<0.001) during the follow-up period.ConclusionA2 Magerl thoracic or lumbar fractures could be successfully treated with PEEK implant-assisted vertebral augmentation. Randomized studies with larger sample sizes should be done to confirm the effectiveness of the technique.