IMPACT OF THE NUMBER OF TREATED VERTEBRAE ON THE SAFETY AND EFFICACY OUTCOMES OF VERTEBROPLASTY AND KYPHOPLASTY; SYSTEMATIC REVIEWS TO SUPPORT THE INDICATION EXPANSION OF THESE PROCEDURES FROM SINGLE-LEVEL TO MULTI-LEVEL FRACTURES IN JAPAN
Author(s)
Tomoyasu Muto, BS, MSci, PhD.
HEOR researcher, CPU - Clients Perspectives United Corp., Tokyo, Japan.
HEOR researcher, CPU - Clients Perspectives United Corp., Tokyo, Japan.
OBJECTIVES: The most common osteoporotic fractures are vertebral, predisposing to increased morbidity and mortality. Vertebral augmentation had been applied only to single-level fractures that account for 64.2% of patients until January 2023 in Japan. Multi-level fractures could not have been treated under full reimbursement coverage in the absence of evidence on safety and efficacy, equivalent to that of single-level fractures. In this study, procedural outcomes of vertebral augmentation were examined in light of the number of vertebrae treated.
METHODS: The PubMed database was searched for literature on vertebroplasty with the keywords (“vertebroplasty”) and (“osteoporotic” or “osteoporosis”). Likewise, another search was conducted for kyphoplasty using (“(“kyphoplasty”) and (“osteoporotic” or “osteoporosis”). After removing the redundant and/or irrelevant literature, Visual Analogue Scores of Preoperative and Postoperative Pain (VAS) and changes in Oswestry Disability Index (ODI) were compared across the selected studies as efficacy outcomes. As safety outcomes, cement leakage, subsequent vertebral fractures were examined for correlation with the number of treated vertebrae.
RESULTS: One paper reported VAS under different numbers of treated vertebrae, where the confidence intervals of VAS changes overlapped. 8 papers reported ODI changes showing no difference between single-level and multi-level fractures. Cement leakage was reported in 35 papers, demonstrating a weak negative correlation (R = - 0.135) to the number of treated vertebrae. 9 papers reported symptomatic adjacent fractures in a weak positive correlation (R = 0.146), while 8 reported symptomatic adjacent fractures in a weak negative correlation (R = -0.222) to the number of treated vertebrae. Three papers reported all radiographic adjacent fractures in a weak negative correlation (R = - 0.189), while 4 reported all radiographic newly diagnosed fractures in a weak negative correlation (R = - 0.167) to the number of treated vertebrae.
CONCLUSIONS: Vertebral augmentation for multi-level fractures was considered as safe and effective as that for single-level fractures.
METHODS: The PubMed database was searched for literature on vertebroplasty with the keywords (“vertebroplasty”) and (“osteoporotic” or “osteoporosis”). Likewise, another search was conducted for kyphoplasty using (“(“kyphoplasty”) and (“osteoporotic” or “osteoporosis”). After removing the redundant and/or irrelevant literature, Visual Analogue Scores of Preoperative and Postoperative Pain (VAS) and changes in Oswestry Disability Index (ODI) were compared across the selected studies as efficacy outcomes. As safety outcomes, cement leakage, subsequent vertebral fractures were examined for correlation with the number of treated vertebrae.
RESULTS: One paper reported VAS under different numbers of treated vertebrae, where the confidence intervals of VAS changes overlapped. 8 papers reported ODI changes showing no difference between single-level and multi-level fractures. Cement leakage was reported in 35 papers, demonstrating a weak negative correlation (R = - 0.135) to the number of treated vertebrae. 9 papers reported symptomatic adjacent fractures in a weak positive correlation (R = 0.146), while 8 reported symptomatic adjacent fractures in a weak negative correlation (R = -0.222) to the number of treated vertebrae. Three papers reported all radiographic adjacent fractures in a weak negative correlation (R = - 0.189), while 4 reported all radiographic newly diagnosed fractures in a weak negative correlation (R = - 0.167) to the number of treated vertebrae.
CONCLUSIONS: Vertebral augmentation for multi-level fractures was considered as safe and effective as that for single-level fractures.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
CO20
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
SDC: Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal), STA: Surgery