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

Early Phase 1

Completed

Conditions: osteoporotic vertebral compression fracture

Registration Number: ITMCTR2024000040

Lead Sponsor: Wangjing Hospital, China Academy of Traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: Not specified

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

(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.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Puncture frequency;Time required for puncture;

Secondary Outcome Measures

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