Efficacy of Kyphoplasty With a New Intervertebral Expander

Mohammad ARAB MOTLAGH

Status: Completed

Conditions: Vertebral Body Compression

Treatments: Procedure: Kyphoplasty

Study type: Observational

Funder types: Other

Identifiers

NCT03521661

Kyphoplasty

Details and patient eligibility

About

Balloon kyphoplasty is a well-established treatment option to achieve pain relief and to correct kyphotic deformity caused by osteoporotic vertebral compression fracture. However, it has been demonstrated that reduction is partly lost as balloon is deflated in the vertebral body. An intravertebral expander was developed for better reduction and maintenance of vertebral body height while cement is injected. This study evaluates the efficacy of kyphoplasty with a new intravertebral expander with regard to correction of kyphosis angel and to restoration of vertebral body height.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osteoporotic vertebral body fractures that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification

Exclusion criteria

• More than 2 vertebral body fractures
• Fractures of vertebral body based on malignancy
• Previous spinal operation
• Spinal infection
• Spinal deformity (scoliosis)

Trial design

41 participants in 1 patient group

Kyphoplasty

Description:

Patients underwent kyphoplasty with an intravertebral expander

Treatment:

Procedure: Kyphoplasty