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Assessment of the efficacy and safety using active bone repair materials for lacunar bone defect, a multicenter, randomized controlled trial

Assessment of the efficacy and safety using active bone repair materials for lacunar bone defect, a multicenter, randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006222
Enrollment
Unknown
Registered
2015-01-31
Start date
2013-10-29
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

fracture with bone defect

Interventions

Control versus Experimental:OSTEOSET versus active bone repair materials

Sponsors

Peking university people's hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, 18-75 years old; 2. fracture happened less than two weeks; 3. the defect should be more than 1 cm Diameter, the volume less than ten cubic centimeter; 4. the pregnancy tests of the childbearing women should be negtive and have the willingness to take contraceptive measures in the whole trial process; 5. Patients signed informed consent.

Exclusion criteria

Exclusion criteria: 1. old fracture; 2. pathologic fracture; 3. Severe heart, liver, kidney ,other important organs, endocrine and severe blood disease System disease and related medical history cannot be implemented fracture internal fixation surgery; 4. Infection can't control; 5. Severe open injury lead to fracture cannot be implemented internal fixation treatment of patients; 6. Pregnant Or Lactating Women; 7. patients with insanity; 8. Allergic constitution, or ever had severe allergic reactions; 9. patients with immature bone; 10. patients with tumor; 11. Bone defect patients of severe damage to peripheral nerve blood vessels; 12. any other patients considered to be excluded.

Design outcomes

Primary

MeasureTime frame
Safety;image;

Contacts

Public ContactDang Yu
drdangyu@163.com+86 18663826271

Outcome results

None listed

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