Initial hospitalization with rigorous bed rest followed by bracing and rehabilitation as an option of conservative treatment for osteoporotic vertebral fractures in elderly patients: a pilot one arm safety and feasibility study

SUMMARY: We assessed the safety and feasibility of a unified conservative treatment protocol for osteoporotic vertebral fractures in the elderly patients with a 24-week follow-up. Our results showed that initial hospitalization with rigorous bed rest followed by a rehabilitation program using a Jewett brace was safe and feasible in managing patients. PURPOSE: The purpose of this study was to prove the safety and feasibility of a unified conservative treatment protocol, which included initial hospitalization with rigorous bed rest followed by a rehabilitation program with Jewett brace for osteoporotic vertebral fractures (OVFs) in the elderly patients with a 24-week follow-up. METHODS: Between April 2012 and Mach 2015, one hundred fifty-four patients met the eligibility for this study. Radiological findings at the 3-week, 6~8-week, 24-week assessment were evaluated. Among these, 11 patients underwent early surgery within the first 2 weeks after admission and 19 patients lost follow-up. Therefore, 124 patients were assessed at the final follow-up visit. RESULTS: The average vertebral instability in all the present series was 4.9 ± 4.8° at 3-week, 2.9 ± 3.5° at 6~8-week, and 1.8 ± 3.0° at 24-week follow-up visit. Delayed union was observed in 16 patients on the 24-week follow-up visit. Therefore, the present conservative treatment protocol resulted in bony union in 98 out of 124 patients (79.0%, per protocol set analysis) and 98 out of 154 patients including drop-out (63.6%, intention-to-treat analysis). There was no severe adverse event related to initial bed rest. The vertebral instability at 3-week assessment was significantly higher in the delayed union group when compared with that in the union group. Univariate analyses followed by multivariate logistic regression analysis revealed that T2-weighted image of confined high intensity on MRI and having more than 5° of vertebral instability on dynamic X-ray at 3-week assessment are the independent risk factors for delayed union of conservative treatment in the present series. CONCLUSIONS: Our results showed that initial hospitalization with rigorous bed rest followed by a rehabilitation program using a Jewett brace was safe and feasible. Therefore, the present conservative treatment protocol can be one of the acceptable treatment options in managing OVF patients.