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Clinical trial of absorbable internal materials in orthopedics

Clinical trial of absorbable internal materials in orthopedics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004270
Enrollment
Unknown
Registered
2014-02-08
Start date
2014-02-15
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

Interventions

The test group:“Boshuobei”absorbable internal materials
Control:Biofix absorbable internal materials

Sponsors

Tianjin Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients need for internal fixation of using absorbable screws, bone plates, bone stick therapy were informed consent, in accordance with regulations on the administration of medical institutions under the state council. Before the test, the subjects must meet all of the following requirements, can enter group: 1) aged 18-65 years old, men and women are not limited; 2) operation incision for I, II incision; 3) AST, ALT, BUN, Cr no more than double the normal value; non hepatitis A, hepatitis B, AIDS, tuberculosis, etc. infectious diseases in the active phase and psychiatric patients; 4) of fresh limbs cancellous bone fractures, intra-articular fracture or short bone diaphysis fracture; 5) agreed to sign the informed consent and may in accordance with the scheme regular referral, follow-up.

Exclusion criteria

Exclusion criteria: Before the test, participants meet the requirements under an arbitrary, not into the group: 1) does not meet the above criteria were included; 2) before the study began 3 months participated in other clinical trials; 3) although the exclusion criteria, but refused to use the absorbable screw fixation; 4) severe osteoporosis.

Design outcomes

Primary

MeasureTime frame
6 months clinical healing rate;

Countries

China

Contacts

Public ContactWan Chunyou
wanchunyouxs@163.com+86 13132003200

Outcome results

None listed

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