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A development of a new device for percutaneous kyphoplasty and its clinical application in the treatment of OVCFs

A development of a new device for percutaneous kyphoplasty and its clinical application in the treatment of OVCFs

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047831
Enrollment
Unknown
Registered
2021-06-27
Start date
2021-06-24
Completion date
Unknown
Last updated
2022-03-07

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

Conditions

Vertebral compression fracture

Interventions

Experimental group vs control group:Different instruments were used in the operation

Sponsors

General Hospital of Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged >= 60 years; 2. Osteoporotic vertebral fractures; 3. With severe back pain, non-surgical treatment is ineffective; 4. The responsible vertebral body is a single segment.

Exclusion criteria

Exclusion criteria: 1. Serious chronic diseases such as heart, liver, kidney disease or malignant tumor; 2. Asymptomatic stable fractures, traumatic vertebral fractures caused by high-energy injury; 3. Vertebral infection, tumor diseases; 4. Fractures cause the volume of the spinal canal to become smaller and cause neurological symptoms; 5. Those who have coagulation disorders and are allergic to PKP materials; 6. Local severe kyphosis, the height of the vertebral body is less than 1/4 of the normal vertebral body. 7. The patient's compliance is poor, and the researcher determines that the trial cannot be completed according to the research plan. There are also patients who are participating in other clinical trials; researchers believe that other reasons are not suitable for clinical trials (eg, excessive daily alcohol or smoking, drug use).

Design outcomes

Primary

MeasureTime frame
vertebral height;

Countries

China

Contacts

Public ContactLiu Jianheng

General Hospital of Chinese People's Liberation Army

jianhengliu@126.com+86 18201496886

Outcome results

None listed

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