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.

Condition	Intervention	Phase
Acute open tibial shaft fractures	Drug: InductOs	Phase IV

Further Study Details: 

Primary Outcomes: Subjects with healed fractures, measured at 2 distinct time points after treatment administration: 13 weeks and 20 weeks.
Secondary Outcomes: Corroboration of fracture healing assessment by masked,independent radiology panel.
Expected Total Enrollment:  300

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00161616

Trial Manager       clinicaltrialinfo@wyeth.com

Belgium
      Gent,  9000,  Belgium; Recruiting
Finland
      Turku,  20520,  Finland; Recruiting
France
      Toulouse,  31400,  France; Recruiting
      Creteil,  94010,  France; Recruiting
Germany
      Berlin,  13353,  Germany; Recruiting
      MÜNSTER,  48149,  Germany; Recruiting
      Mainz,  55101,  Germany; Not yet recruiting
Italy
      Roma,  00168,  Italy; Recruiting
      Pavia,  27100,  Italy; Recruiting
Norway
      Oslo,  0407,  Norway; Recruiting
      BERGEN,  5021,  Norway; Recruiting
South Africa
      Cape Town,  7925,  South Africa; Not yet recruiting
      Tygerberg,  7505,  South Africa; Recruiting
      Durban,  4001,  South Africa; Recruiting
      Centurion,  0157,  South Africa; Not yet recruiting
      Bloemfontein,  South Africa; Recruiting
Spain
      Balalona- Barcelona,  8915,  Spain; Not yet recruiting
      Alcala- Madrid,  28805,  Spain; Recruiting
United Kingdom
      Norwich,  NR4 7 UY,  United Kingdom; Recruiting
      Belfast,  BT12 6BA,  United Kingdom; Not yet recruiting
      Bristol,  BS2 8HW,  United Kingdom; Recruiting
      Northampton,  NN1 5BD,  United Kingdom; Recruiting

Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research   

Study ID Numbers:  3100N8-400
Last Updated:  September 11, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00161616
Health Authority: European Union: European Medicines Agency
ClinicalTrials.gov processed this record on 2005-09-13