Unilateral versus bilateral balloon kyphoplasty in treatment of osteoporotic vertebral compression fractures: A randomized controlled trial protocol.

ABSTRACT

BACKGROUND: It is currently controversial whether unilateral or bilateral balloon kyphoplasty (BKP) is superior in terms of postoperative outcomes in treatment of osteoporotic vertebral compression fracture (OVCF). In this context, the aim of this study was to prospectively evaluate and compare the radiographic and clinical outcomes of BKP using unilateral and bilateral approaches. METHODS: This was a randomized controlled study and was approved by the Severance Institutional Review Board in our hospital. The study protocol was designed in accordance with the Declaration of Helsinki guidelines. Patients who complained of chronic back pain secondary to OVCF, which occurred in thoracic lumbar region over 6 months and met the criteria of osteoporosis were the candidates for this procedure. A total of 150 patients were randomized to undergo either unilateral or bipedicular BKP. The outcomes measures inculded pain score, Oswestry Dysfunction Index, compression ratio, kyphotic angle, operation time, and postoperative complications. RESULTS: We were able to directly compare the outcomes of unilateral versus bilateral BKP and might reveal a better technique in OVCF. TRIAL REGISTRATION this study protocol was registered in Research Registry (researchregistry5543).