Prospective clinical trial to establish optimal strategy of conservative management for osteoporotic vertebral fractures

Not Applicable

• Conditions: osteoporotic vertebral fracture

• Registration Number: JPRN-UMIN000003109
• Lead Sponsor: Japanese Orthopaedic Association, Spine and Spinal Cord Disease Committee

Brief Summary

Introduction: Optimal conservative management for acute thoracolumbar osteoporotic vertebral compression fractures (VCF) are still under debate. This multicenter prospective RCT was undertaken to verify optimal treatment protocol for VCF. Methods: Patients with acute osteoporotic VCF who visited participating hospitals were enrolled. Inclusion criteria were 1) 65 to 90 y/o female; 2) fractures between T11 and L2; 3) those without neurological deficits. Diagnosis of VCF was established by X-ray and MRI. Pathological fractures and those with significant canal compromise were excluded. Patients were randomly assigned to one of three treatment groups. Group 1: 3 weeks bed rest followed by semirigid brace, Group 2: early mobilization with cast, followed by semirigid brace then simple corset, and Group 3: early mobilization with simple brace only. External supports were continued until 12 weeks post-injury. Rate of nonunion, progression of vertebral deformity, pain, SF-36 and neurological status were compared among three groups. Results: Forty-three patients were included and 14, 15, and 14 patients were assigned to each group. Nonunion rates were not significantly different among three groups, however, union tended to be delayed in Group 1. Most vertebral deformity occurred between 4-8 weeks, and none of treatments could prevent vertebral deformity completely. Vertebral wedge rate and Social Function score of SF-36 were significantly superior in Group 2 than 1. There were no other parameters that were significantly different among three groups. Discussion: This is first RCT comparing clinical and radiological results of different conservative treatments for patients with VCF. Prolonged bed rest did not prevent vertebral deformity nor improved clinical results, therefore, early mobilization is justified. Although complete prevention of deformity progression was not possible, rigid external support may be favored over simple corset.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-01
• Study Completion: 2010-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Patient who 1. has pathological fracture 2. has malignancies 3. has participated in a different trail on osteoporosis within 6 months 4. is unable to undergo MRI 5. had been unable to walk before injury 6. has unhealed previous vertebral fractures 7. has demintia 8. is judged inappropriate to participate in this study by the investigators 8. has severe general complications that hampers proper rehabilitation

Study & Design

• Study Type: Interventional
• Study Design: Not specified