Establishment of effective and efficient minimally invasive surgical treatment for fresh osteoporotic vertebral fracture with a poor prognostic factor - prospective multicenter intervention study -

Establishment of effective and efficient minimally invasive surgical treatment for fresh osteoporotic vertebral fracture with a poor prognostic factor - prospective multicenter intervention study - - Early stage surgical intervention study for fresh OVF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018681

Enrollment

100

Registered

2015-08-14

Start date

2015-08-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fresh osteoporotic vertebral fracture

Interventions

Balloon KyphoPlasty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) osteoporotic vertebral fracture 2) Patients that can be planned surgical medical treatment within the onset 8 weeks 3) 65 years of age or older at the time of obtaining informed consent 4) poor prognostic factor in MRI findings (Diffuse low intensity or Confined high intensity in the T2 weighted image)

Exclusion criteria

Exclusion criteria: 1) In the case of fractures difficult to use "KYPHON BKP system" (pedicle fracture and flattened vertebral, severe bone defect of posterior wall of the vertebral body, etc.) 2) a severe brain and cardiopulmonary vascular disease 3) systemic infection or local infection of fractured vertebral body 4) a hemorrhagic diathesis 5) a history of hypersensitivity to bone cement or contrast agent 6) dementia 7) malignant tumors 8) a lower limb paralysis or bladder rectal disorder

Design outcomes

Primary

Measure	Time frame
ADL impairment at 6 months	—

Countries

Japan

Contacts

Public ContactMasatoshi Hoshino

Osaka City University Graduate School of Medicine Department of Orthopaedic Surgery

hoshino717@gmail.com06-6645-3851

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026