NCT02049931

Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace

The Comparative Study for Treatment Outcomes of Osteoporotic Compression Fracture Without Neurologic Injury Using Rigid Brace, Soft Brace, and no Brace

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace.

Detailed description

Bracing has been considered as a landmark step in conservative management for osteoporotic compression fractures. However, no prospective, randomized, and controlled clinical trials are available to document for the efficacy of wearing of the rigid or soft brace for the management of osteoporotic compression fracture. Therefore, the current trial was therefore designed to compare the outcome for improvement of disability and pain in patients with osteoporotic compression fracture using rigid, soft, or no brace.

Conditions

• Compression Fracture

Interventions

Type	Name	Description
DEVICE	No brace treatment	Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable.
DEVICE	Rigid brace	In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
DEVICE	Soft brace	In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-10-01
• Completion: 2014-01-01
• First posted: 2014-01-30
• Last updated: 2018-08-07
• Results posted: 2015-05-25