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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00161616 |
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Date of registration:
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07/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating InductOs in Diaphyseal Tibia Fractures
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Scientific title:
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A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation |
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Date of first enrolment:
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September 2003 |
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Target sample size:
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277 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00161616 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Belgium
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Finland
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France
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Germany
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Italy
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Netherlands
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Norway
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Poland
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Romania
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South Africa
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Spain
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United Kingdom
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Romania, WVPIMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For UK/Great Britian, ukmedinfo@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Germany, MedInfoDEU@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Italy, descresg@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For South Africa, ZAFinfo@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Belgium, trials-BEL@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For France, infomedfrance@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Spain, infomed@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Netherlands, trials-NL@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Norway, Finland, MedInfoNord@wyeth.com |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tibial Fractures
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Intervention(s)
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Drug: InductOs
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Primary Outcome(s)
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Number of Patients With Healed Fractures
[Time Frame: 13 and 20 weeks]
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Secondary Outcome(s)
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Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE)
[Time Frame: 1 year]
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Secondary ID(s)
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3100N8-400
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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