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Study Evaluating InductOs in Diaphyseal Tibia Fractures

Last updated on February 20, 2019

FOR MORE INFORMATION
Study Location
Gent, , 9000 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tibial Fractures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with acute open tibial shaft fractures (Gustilo Type I, II, IIIA, or IIIB)
who require surgical management with reamed, statically locked intramedullary nail
fixation and who are at low risk for amputation.

- Subjects should be at least 18 years of age, be skeletally mature, and be able to
provide written informed consent.

- Initial fracture stabilization and wound debridement should occur within 1 day after
injury and DFC should occur within 14 days after injury.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Planned treatment for the fracture should not include further procedures to promote
fracture healing. After 16 weeks have elapsed since DFC, unanticipated procedures to
promote fracture healing are permitted as clinically indicated.

- Presence of fracture distraction > 2 mm following definitive fracture fixation.

- Presence of purulent drainage from the fracture site or evidence of active
osteomyelitis.

NCT00161616
Pfizer
Completed
Study Evaluating InductOs in Diaphyseal Tibia Fractures

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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