Study Evaluating InductOs in Diaphyseal Tibia Fractures
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161616
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Hide Study LocationsLocations
| 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 May 22, 2013