Compression Fracture Spine, Osteoporosis Fracture
Conditions
Keywords
Compression fracture, postural reduction, vertebroplasty
Brief summary
Vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly popular. However, there have been some limitations in restoring the height of the collapsed vertebrae and in preventing the leaking of cement. In the severely collapsed vertebrae of more than two thirds of their original height, vertebroplasty is regarded as a contraindication. We tried postural reduction using a soft pillow under the compressed level. This study was undertaken to investigate the effectiveness of the combination of postural reduction and vertebroplasty for re-expansion and stabilization of the osteoporotic vertebral fractures. single level vertebral compression fracture were treated with postural reduction followed by vertebroplasty. We analyzed the degree of re-expansion according to the onset duration.
Interventions
OTHERPillow
A soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Patients eligible for the study were selected by an independent research assistant. The study was explained, and informed consent was obtained from patients before the surgery. Using a randomization sequence, the patients were assigned to the international or control group. The attending surgeons and patients were blinded before the surgery.
Intervention model description
Patients with single level osteoporotic compression fracture
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Single level osteoporotic compression fracture of thoracic and lumbar spine
Exclusion criteria
* Can't tolerate the postural reduction by pillow * Pathological spine fracture caused by tumor, infection. * Multiple spine fractures * Patient presented with neurological. deficits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sagittal plane contour | 6 months of post-operative follow up | Sagittal plane measurement by measuring the Cobb angle of the injured vertebral on lateral radio-graphs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome | 6 months of post-operative follow up | Visual Analogue Scale This is a pain scale, 10 scoes is the worest pain ever. 0 scores is no pain |
Countries
Taiwan
Contacts
Primary ContactMing-Chau Chang, M.D.
Backup ContactYu-Cheng Yao, M.D.
Outcome results
None listed