We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating InductOs in Diaphyseal Tibia Fractures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00161616
First Posted: September 12, 2005
Last Update Posted: September 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
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
Tibial Fractures Drug: InductOs Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Number of Patients With Healed Fractures [ Time Frame: 13 and 20 weeks ]

Secondary Outcome Measures:
  • Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE) [ Time Frame: 1 year ]

Enrollment: 277
Study Start Date: September 2003
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage +surgical fixation
Drug: InductOs
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage
B
Standard of Care: Surgical fixation only
Drug: InductOs
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161616


  Show 27 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, MedInfoDEU@wyeth.com
Principal Investigator: Trial Manager For Italy, descresg@wyeth.com
Principal Investigator: Trial Manager For South Africa, ZAFinfo@wyeth.com
Principal Investigator: Trial Manager For Norway, Finland, MedInfoNord@wyeth.com
Principal Investigator: Trial Manager For Spain, infomed@wyeth.com
Study Chair: Trial Manager For UK/Great Britian, ukmedinfo@wyeth.com
Principal Investigator: Trial Manager For Belgium, trials-BEL@wyeth.com
Principal Investigator: Trial Manager For France, infomedfrance@wyeth.com
Principal Investigator: Trial Manager For Romania, WVPIMED@wyeth.com
Principal Investigator: Trial Manager For Netherlands, trials-NL@wyeth.com
  More Information

Responsible Party: Wyeth (Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00161616     History of Changes
Other Study ID Numbers: 3100N8-400
First Submitted: September 7, 2005
First Posted: September 12, 2005
Results First Submitted: July 31, 2009
Results First Posted: September 7, 2009
Last Update Posted: September 7, 2009
Last Verified: July 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Open Diaphyseal Tibia Fractures

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries