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Clinical Study on Improving the Safety of Osteoporosis Spinal Compression Fractures Plastic Surgery with Bone Cement Guided Device

Clinical Study on Improving the Safety of Osteoporosis Spinal Compression Fractures Plastic Surgery with Bone Cement Guided Device

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078832
Enrollment
Unknown
Registered
2023-12-19
Start date
2023-12-25
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Osteoporotic vertebral compressibility fracture

Interventions

Regular Group:Bone setting technique combined with conventional PVP surgery
Improvement group: Bone setting technique combined with improved PVP surgery

Sponsors

Jiangsu Province Integrated Traditional Chinese and Western Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 100 Years

Inclusion criteria

Inclusion criteria: ? In accordance with the "Guidelines for the Diagnosis and Treatment of Osteoporosis Fractures (2022)", the fracture was confirmed as a fresh fracture through X-ray, CT, and MRI examinations, and surgical contraindications were excluded. ? The patient is aware of the treatment plan and signs the informed consent form for the surgery. The case information is complete, the contact information is truthful and reliable, and the follow-up content can be completed regularly according to regulations; ? After the number of fractured vertebral bodies is = 2 and conservative treatment is ineffective, it is converted to surgical treatment; ? The follow-up period is = 1 year, and the condition is stable during the follow-up period without serious complications. The follow-up data is complete.

Exclusion criteria

Exclusion criteria: ? Diagnosed as pathological vertebral compression caused by vertebral tumors, myeloma, etc; ?Complicated with severe heart, lung, liver, kidney dysfunction, hematopoietic and coagulation system disorders, and other diseases; ? Patients with a history of mental illness, dementia, etc. who are unable to cooperate in completing relevant examinations, treatments, and pain assessments; ? Long term use of hormone drugs; ? Patients with infection throughout the body or puncture site.

Design outcomes

Primary

MeasureTime frame
Vertebral anterior edge height;Cobb angle of injured vertebra;

Secondary

MeasureTime frame
VAS scores;ODI scores;

Countries

China

Contacts

Public ContactKang Ran

Jiangsu Province Integrated Traditional Chinese and Western Medicine Hospital

kangran126@126.com+86 132 7088 7947

Outcome results

None listed

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