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Optimization of a homemade spinal positioning device and its application in vertebral compression fracture kyphoplasty

Optimization of a homemade spinal positioning device and its application in vertebral compression fracture kyphoplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000040
Enrollment
Unknown
Registered
2024-04-02
Start date
2023-07-25
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

osteoporotic vertebral compression fracture

Interventions

Control Group:Traditional Kirschner wire positioning
Trial Group:Self made spinal positioning device for positioning

Sponsors

Wangjing Hospital, China Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (1) Meet the above Western medical diagnosis (2) Female age range from 50 to 80 years old, male age range from 60 to 90 years old; Lumbar or hip bone density T-value = -2.5SD; Fresh single vertebral fracture, with the fracture site located at T10-L1; (3) The patient's conservative treatment is ineffective or not suitable for prolonged bed rest, and they can tolerate surgery; (4) The patient's coagulation function, health status, and soft tissue conditions in the lower back meet the requirements for surgical treatment; (5) The patient and their family members agree to minimally invasive vertebral body reconstruction surgery and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (1) vertebral burst fractures with symptoms of spinal cord nerve root injury; (2) Patients with Cobb angle = 40 ° or loss of anterior column height = 50% caused by vertebral fractures, and thoracic/lumbar imaging showing cortical defects in the posterior wall of the vertebral body (3) combined with vertebral tuberculosis, bacterial infection, and other vertebral lesions; (4) Patients with pathological vertebral fractures caused by tumor diseases or other factors; (5) Conservative or open surgical treatment should be adopted. (6) Patients who cannot cooperate with the study or do not agree to participate in this study or are currently participating in other clinical trial trials.

Design outcomes

Primary

MeasureTime frame
Puncture frequency;Time required for puncture;

Secondary

MeasureTime frame
Success rate of one puncture;visual analogue scale,VAS;Japanese Orthopaedic Association Scores,JOA;Number of X-ray examinations;modified MacNab criteria,MacNab;

Countries

China

Contacts

Public ContactWang Shangquan

Wangjing Hospital of the Chinese Academy of Traditional Chinese Medicine

wsqdyf@163.com13901147122

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026