STUDY DESIGN: A prospective comparative study. OBJECTIVE: To assess the clinical and radiological outcomes for the treatment of osteoporotic vertebral compression fractures using unilateral transverse process-pedicle and bilateral percutaneous kyphoplasty (PKP). SUMMARY OF BACKGROUND DATA: PKP is a widely used vertebral augmentation procedure for treating painful vertebral compression fractures. A percutaneous bilateral approach is typically used to access the vertebral body. Many previous studies have reported excellent clinical results with PKP. In contrast, numerous complications and problems have also been reported, such as puncture difficulty, cement leakage, and adjacent vertebral fracture. METHODS: This prospective study included 316 patients with single-level lumbar osteoporotic vertebral compression fracture, 224 females and 92 males with a mean age of 71.5 years. Randomized patients underwent PKP using 2 different puncture techniques. The patients were followed up postoperatively and were assessed mainly with regard to clinical and radiological outcomes. Clinical outcomes were evaluated mainly using the visual analogue scale for pain and 36-Item Short Form Health Survey (SF-36) questionnaire for health status. Radiological outcomes were assessed mainly on the basis of radiation dose, bone cement distribution, vertebral body height, and kyphotic angle. RESULTS: Patients were followed up from 12 to 28 months, with an average of 16.8 months. One hundred fifty-eight patients were treated with unilateral method and 151 patients were treated with bilateral method. In the unilateral group, the volume of the injected cement and radiation dose were significantly less than that in the bilateral group. All patients in both groups had significantly less pain after the procedures, compared with their preoperative period pain. No statistically significant differences were observed when visual analogue scale and 36-Item Short Form Health Survey were compared between the groups. Both unilateral and bilateral groups showed insignificant decrease in the kyphotic angle during the follow-ups. The kyphotic angle in the unilateral group improved more significantly than in the bilateral group. In the bilateral group, 16 patients had obvious pain in the puncture sites at 1 month postoperatively caused by facet joint violation. With local block treatment, the pain disappeared in all patients at the last follow-up. CONCLUSION: Both bilateral and unilateral PKP are relatively safe and provide effective treatment for patients with painful osteoporotic vertebral compression fracture. However, unilateral PKP received less radiation dose and operation time, it also offered a higher degree of deformity correction and resulted in less complication than bilateral PKP.
RCT Entities:
STUDY DESIGN: A prospective comparative study. OBJECTIVE: To assess the clinical and radiological outcomes for the treatment of osteoporotic vertebral compression fractures using unilateral transverse process-pedicle and bilateral percutaneous kyphoplasty (PKP). SUMMARY OF BACKGROUND DATA: PKP is a widely used vertebral augmentation procedure for treating painful vertebral compression fractures. A percutaneous bilateral approach is typically used to access the vertebral body. Many previous studies have reported excellent clinical results with PKP. In contrast, numerous complications and problems have also been reported, such as puncture difficulty, cement leakage, and adjacent vertebral fracture. METHODS: This prospective study included 316 patients with single-level lumbar osteoporotic vertebral compression fracture, 224 females and 92 males with a mean age of 71.5 years. Randomized patients underwent PKP using 2 different puncture techniques. The patients were followed up postoperatively and were assessed mainly with regard to clinical and radiological outcomes. Clinical outcomes were evaluated mainly using the visual analogue scale for pain and 36-Item Short Form Health Survey (SF-36) questionnaire for health status. Radiological outcomes were assessed mainly on the basis of radiation dose, bone cement distribution, vertebral body height, and kyphotic angle. RESULTS:Patients were followed up from 12 to 28 months, with an average of 16.8 months. One hundred fifty-eight patients were treated with unilateral method and 151 patients were treated with bilateral method. In the unilateral group, the volume of the injected cement and radiation dose were significantly less than that in the bilateral group. All patients in both groups had significantly less pain after the procedures, compared with their preoperative period pain. No statistically significant differences were observed when visual analogue scale and 36-Item Short Form Health Survey were compared between the groups. Both unilateral and bilateral groups showed insignificant decrease in the kyphotic angle during the follow-ups. The kyphotic angle in the unilateral group improved more significantly than in the bilateral group. In the bilateral group, 16 patients had obvious pain in the puncture sites at 1 month postoperatively caused by facet joint violation. With local block treatment, the pain disappeared in all patients at the last follow-up. CONCLUSION: Both bilateral and unilateral PKP are relatively safe and provide effective treatment for patients with painful osteoporotic vertebral compression fracture. However, unilateral PKP received less radiation dose and operation time, it also offered a higher degree of deformity correction and resulted in less complication than bilateral PKP.
Authors: Jin Peng Du; Yong Fan; Ji Jun Liu; Jia Nan Zhang; Yan Sheng Huang; Jing Zhang; Ding Jun Hao Journal: Sci Rep Date: 2018-05-29 Impact factor: 4.379