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Comparisonof NICE and PVP in the Treatment of Lumbar Osteoporotic Vertebral Compression Fractures: a Conservative Treatment- Controlled, Randomized, Open Label Clinical Study

Comparisonof NICE and PVP in the Treatment of Lumbar Osteoporotic Vertebral Compression Fractures: a Conservative Treatment- Controlled, Randomized, Open Label Clinical Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037252
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-13

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

Conditions

Lumbar osteoporotic vertebral compression fractures

Interventions

Group NICE :NICE operation
Group PVP:PVP operation

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) The age of the patients was 45-75 years old, and they were willing to sign the informed consent; 2) The patient was diagnosed as osteoporotic vertebral compression fracture; 3) The patients presented with lumbar pain, activity limitation, numbness and weakness of lower limbs, nerve root compression symptoms, which may be accompanied by dysfunctions of urination and defecation.

Exclusion criteria

Exclusion criteria: 1) Inflammatory diseases such as lumbar tumor, lumbar disc herniation, degenerative scoliosis, lumbar tuberculosis, etc; 2) Patients with other spinal diseases affecting clinical symptoms; 3) Other diseases such as amyotrophy of the motor cord and other diseases were found; 4) Poor physical condition, unable to tolerate surgery; 5) The patients (or their guardians) with cognitive dysfunction can not give full informed consent; 6) Patients who participated in other clinical trials in the past month; 7) Patients with active hepatitis B (including large three positive or small three positive) or serological markers (HBsAg or / and HBeAg or / and HBcAb), hepatitis C, pulmonary tuberculosis, cytomegalovirus, severe fungal infection or HIV infection; 8) There were active peptic ulcer in 3 months before randomization.

Design outcomes

Primary

MeasureTime frame
VAS score;

Secondary

MeasureTime frame
SF-36;

Countries

China

Contacts

Public ContactWang Yuan

Shanghai Changzheng Hospital

13701948727@163.com+86 13701948727

Outcome results

None listed

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