Study Evaluating InductOs in Diaphyseal Tibia Fractures

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00161616
First received: September 7, 2005
Last updated: July 31, 2009
Last verified: July 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161616

  Hide Study Locations
Locations
Belgium
Gent, Belgium, 9000
Finland
Turku, Finland, 20520
France
Creteil, France, 94010
Toulouse, France, 31400
Germany
Berlin, Germany, 13353
Mainz, Germany, 55131
Muenster, Germany, 48149
Italy
Pavia, Italy, 27100
Roma, Italy, 00168
Netherlands
Rotterdam, Netherlands, 3015 GD
Norway
Bergen, Norway, 5021
Oslo, Norway, 0407
Poland
Bialystok, Poland, 15276
Lublin, Poland, 20954
Sosnowiec, Poland, 41200
Szczecin, Poland, 71252
Romania
Bucuresti, Romania, 21659
Bucuresti, Romania, 14461
Bucuresti, Romania, 50098
South Africa
Bloemfontein, South Africa, 9300
Cape Town, South Africa, 7505
Cape Town, South Africa, 7925
Centurion, South Africa, 0157
Durban, South Africa
Spain
Alcala, Spain, 28805
United Kingdom
Bristol, United Kingdom, BS2 8HW
Norwich, United Kingdom, NR4 7 UY
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

No publications provided

Responsible Party: Wyeth (Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00161616     History of Changes
Other Study ID Numbers: 3100N8-400
Study First Received: September 7, 2005
Results First Received: July 31, 2009
Last Updated: July 31, 2009
Health Authority: European Union: European Medicines Agency

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

ClinicalTrials.gov processed this record on September 18, 2014