A multicenter, prospective, single-arm, intervention study.
The aim of this study was to investigate efficacy of balloon kyphoplasty (BKP) for acute osteoporotic vertebral fractures (OVFs) in patients with poor prognostic factors.
The indications for BKP remain unclear. Characteristic magnetic resonance imaging (MRI) findings (high-intensity or diffuse low-intensity area in fractured vertebrae on T2-weighted images) were reportedly predictive of delayed union.
This study enrolled 106 patients with poor prognostic MRI findings who underwent BKP within 2 months after injury, and 116 controls with acute OVFs and the same poor prognostic factors who underwent conservative treatment. Patients were propensity score matched in a logistic regression model adjusted for age, sex, number of baseline old fractures, and fracture level. The primary outcome was reduction in activities of daily living (ADLs) at 6 months after fracture, and the secondary outcomes were improvement in short-form (SF)-36 subscales, back pain visual analog scale (VAS) score, and vertebral body deformity.
A decrease in ADLs occurred in 5.6% of patients in the BKP group and 25.6% of patients in the conservative treatment group (P < 0.001). The SF-36 vitality subscale score improved by 26.9 ± 25.9 points in the BKP group and 14.5 ± 29.4 points in the control group (P = 0.03). The VAS pain score improved by 43.4 ± 34.4 in the BKP group and 52.2 ± 29.8 in the control group (P = 0.44). The vertebral body wedge angle improved by 5.5 ± 6.2° in the BKP group and −6.3 ± 5.0° in the control group (P < 0.0001). The percent vertebral body height improved by 15.2 ± 19.2% in the BKP group and −20.6 ± 14.2% in the control group (P < 0.0001).
ADLs, quality of life, and vertebral deformity showed greater improvement with BKP intervention for acute OVF with poor prognostic factors than with conservative treatment at 6 months after injury. Our treatment strategy uses BKP intervention according to the presence or absence of poor prognostic MRI findings.
Level of Evidence: 4
∗Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan
†Department of Orthopaedic Surgery, Osaka General Hospital of West Japan Railway Company, Osaka, Japan
‡Department of Orthopaedic Surgery, Shimada Hospital, Osaka, Japan
§Department of Orthopaedic Surgery, Shiraniwa Hospital, Nara, Japan
¶Department of Orthopaedic Surgery, Ishikiri Seiki Hospital, Osaka, Japan
||Department of Orthopaedic Surgery, Yodogawa Christian Hospital, Osaka, Japan
∗∗Department of Orthopaedic Surgery, Saiseikai Nakatsu Hospital, Osaka, Japan.
Address correspondence and reprint requests to Masatoshi Hoshino, MD, PhD, Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, 1–4–3 Asahi-machi Abeno-ku, Osaka 545–8585, Japan; E-mail: firstname.lastname@example.org
Received 30 March, 2018
Revised 28 May, 2018
Accepted 6 June, 2018
The device(s)/drug(s) is/are FDA-approved or approved by corresponding national agency for this indication.
The Japan Agency for Medical Research and Development grant funds were received in support of this work.
Relevant financial activities outside the submitted work: payment for lecture.