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A prospective, multicenter, randomized controlled study on the efficacy and safety of emergency bone cement plate internal fixation for severe open fractures of the limbs

A prospective, multicenter, randomized controlled study on the efficacy and safety of emergency bone cement plate internal fixation for severe open fractures of the limbs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111347
Enrollment
Unknown
Registered
2025-10-30
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Open fracture of limbs

Interventions

Experimental group: the fractures were fixed with plate screws (Synthes, Solothurn, Switzerland). The bone defect area and plate surface were covered with antibiotic polymethyl methacrylate (PMMA) ce
Control group:For open fractures of the limbs, after emergency debridement, the fractures were stabilized using a combined external fixator, and the remaining wound was covered with VSD.

Sponsors

Wuxi Ninth People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-65 years (inclusive), any gender; (2) Gustilo IIIA/B type limb fractures; (3) Time from injury to medical consultation <24 hours.

Exclusion criteria

Exclusion criteria: (1) Initial emergency surgery was not performed at our hospital; (2) Emergency amputation; (3) History of mental illness and inability to cooperate independently, or history of central nervous system disease; (4) Complicated with severe multiple systemic injuries, unable to undergo secondary surgery in the short term; (5) Complicated with severe cardiovascular, cerebrovascular, respiratory, or hematologic diseases, unable to tolerate surgery or anesthesia; (6) Pregnant or breastfeeding women; (7) Disagree with the surgical plan or subsequent follow-up; (8) Follow-up less than 12 months; (9) Other situations deemed inappropriate for participation in this clinical trial by the investigators.

Design outcomes

Primary

MeasureTime frame
infection;

Secondary

MeasureTime frame
flap survived;bone union;Functional Rating;

Countries

China

Contacts

Public ContactYongjun Rui

Wuxi Ninth People’s Hospital

wxswkryj123@126.com+86 188 0056 9230

Outcome results

None listed

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