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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00161616
Date of registration: 07/09/2005
Prospective Registration: No
Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Public title: Study Evaluating InductOs in Diaphyseal Tibia Fractures
Scientific title: A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation
Date of first enrolment: September 2003
Target sample size: 277
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00161616
Study type:  Interventional
Study design:   
Phase:  Phase 4
Countries of recruitment
Belgium Finland France Germany Italy Netherlands Norway Poland
Romania South Africa Spain United Kingdom
Contacts
Name:     Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For Belgium, trials-BEL@wyeth.com
Name:     Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For France, infomedfrance@wyeth.com
Name:     Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For Spain, infomed@wyeth.com
Name:     Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For Netherlands, trials-NL@wyeth.com
Name:     Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For Norway, Finland, MedInfoNord@wyeth.com
Name:     Medical Monitor
Address: 
Telephone:
Email:
Affiliation:  Wyeth is now a wholly owned subsidiary of Pfizer
Name:     Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For Germany, MedInfoDEU@wyeth.com
Name:     Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For Italy, descresg@wyeth.com
Name:     Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For South Africa, ZAFinfo@wyeth.com
Name:     Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For Romania, WVPIMED@wyeth.com
Name:     Trial Manager
Address: 
Telephone:
Email:
Affiliation:  For UK/Great Britian, ukmedinfo@wyeth.com
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Tibial Fractures
Intervention(s)
Drug: InductOs
Primary Outcome(s)
Number of Patients With Healed Fractures [Time Frame: 13 and 20 weeks]
Secondary Outcome(s)
Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE) [Time Frame: 1 year]
Secondary ID(s)
3100N8-400
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 07/09/2009
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00161616
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