Clinical trial NCT00161616: Study Evaluating InductOs in Diaphyseal Tibia Fractures
Official title: A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tibial Fractures
Keywords: Open Diaphyseal Tibia Fractures
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Demonstrate a larger proportion of subjects with healed fractures among subjects treated with InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed, locked intramedullary nailing alone.


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.

Primary outcomes:
measure: Number of Patients With Healed Fractures
timeFrame: 13 and 20 weeks
Secondary outcomes:
measure: Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE)
timeFrame: 1 year
Other outcomes:
Locations:
city: Gent
country: Belgium
city: Turku
country: Finland
city: Creteil
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Mainz
country: Germany
city: Muenster
country: Germany
city: Pavia
country: Italy
city: Roma
country: Italy
city: Rotterdam
country: Netherlands
city: Bergen
country: Norway
city: Oslo
country: Norway
city: Bialystok
country: Poland
city: Lublin
country: Poland
city: Sosnowiec
country: Poland
city: Szczecin
country: Poland
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bloemfontein
country: South Africa
city: Cape Town
country: South Africa
city: Cape Town
country: South Africa
city: Centurion
country: South Africa
city: Durban
country: South Africa
city: Alcala
country: Spain
city: Bristol
country: United Kingdom
city: Norwich
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Germany, MedInfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, descresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For South Africa, ZAFinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Norway, Finland, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Spain, infomed@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK/Great Britian, ukmedinfo@wyeth.com
name: Trial Manager
role: STUDY_CHAIR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For France, infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Romania, WVPIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: