Study Evaluating InductOs in Diaphyseal Tibia Fractures
Launched by WYETH IS NOW A WHOLLY OWNED SUBSIDIARY OF PFIZER · Sep 7, 2005
Trial Information
Current as of May 07, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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:
- • 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.
About Wyeth Is Now A Wholly Owned Subsidiary Of Pfizer
Wyeth, now a wholly owned subsidiary of Pfizer, is a global biopharmaceutical company dedicated to advancing healthcare through innovative research and development. With a strong legacy in the pharmaceutical industry, Wyeth focuses on discovering and delivering medicines that address significant medical needs across various therapeutic areas, including vaccines, biologics, and specialty pharmaceuticals. Leveraging Pfizer's extensive resources and expertise, Wyeth continues to drive scientific advancement and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
Bialystok, , Poland
Lublin, , Poland
Durban, , South Africa
Gent, , Belgium
Berlin, , Germany
Rotterdam, , Netherlands
Muenster, , Germany
Toulouse, , France
Creteil, , France
Turku, , Finland
Bergen, , Norway
Oslo, , Norway
Pavia, , Italy
Mainz, Rheinland Pfalz, Germany
Bloemfontein, , South Africa
Sosnowiec, , Poland
Szczecin, , Poland
Bucuresti, , Romania
Cape Town, , South Africa
Centurion, , South Africa
Alcala, , Spain
Bristol, , United Kingdom
Norwich, , United Kingdom
Patients applied
Trial Officials
Medical Monitor
Study Director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager
Principal Investigator
For Germany, MedInfoDEU@wyeth.com
Trial Manager
Principal Investigator
For Italy, descresg@wyeth.com
Trial Manager
Principal Investigator
For South Africa, ZAFinfo@wyeth.com
Trial Manager
Principal Investigator
For Norway, Finland, MedInfoNord@wyeth.com
Trial Manager
Principal Investigator
For Spain, infomed@wyeth.com
Trial Manager
Study Chair
For UK/Great Britian, ukmedinfo@wyeth.com
Trial Manager
Principal Investigator
For Belgium, trials-BEL@wyeth.com
Trial Manager
Principal Investigator
For France, infomedfrance@wyeth.com
Trial Manager
Principal Investigator
For Romania, WVPIMED@wyeth.com
Trial Manager
Principal Investigator
For Netherlands, trials-NL@wyeth.com
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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