Fractures Clinical Trial
Official title:
A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study Of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) In Closed Diaphyseal Tibial Fracture
The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered at the fracture site via percutaneous injection, in combination with standard of care, accelerates fracture union and return to normal function in subjects who have a closed diaphyseal tibial fracture when compared to standard of care alone.
Status | Terminated |
Enrollment | 367 |
Est. completion date | March 2010 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Skeletally mature, male and female subjects who are at least 18 years old. - Closed diaphyseal tibial fracture. - Closed reduction and definitive internal fixation by means of a reamed, locked intramedullary nail within 72 hours after injury. Exclusion Criteria: - Concurrent fractures of the ipsilateral or contralateral lower extremity other than the ipsilateral fibula, that would impede performance on the functional assessment of weight bearing. - Planned procedure(s) to stimulate fracture healing after intramedullary nailing. - Neurovascular impairment of the fractured limb, deep vein thrombosis, or (impending) compartment syndrome. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Pfizer Investigational Site | Buenos Aires | |
Australia | Pfizer Investigational Site | Adelaide | South Australia |
Australia | Pfizer Investigational Site | Herston | Queensland |
Australia | Pfizer Investigational Site | Liverpool | New South Wales |
Australia | Pfizer Investigational Site | New Lambton | New South Wales |
Brazil | Pfizer Investigational Site | Cerequeira Cesar | Sao Paolo |
Brazil | Pfizer Investigational Site | Vila Clemetino | Sao Paulo |
Canada | Pfizer Investigational Site | Ajax | Ontario |
Canada | Pfizer Investigational Site | Montreal | Quebec |
Canada | Pfizer Investigational Site | Oshawa | Ontario |
Canada | Pfizer Investigational Site | Scarborough | Ontario |
Canada | Pfizer Investigational Site | Sherbrooke | Quebec |
Canada | Pfizer Investigational Site | Windsor | Ontario |
Canada | Pfizer Investigational Site | Windsor | Ontario |
Finland | Pfizer Investigational Site | Oulu | |
Finland | Pfizer Investigational Site | Turku | |
France | Pfizer Investigational Site | Angers | |
France | Pfizer Investigational Site | Créteil | |
France | Pfizer Investigational Site | Marseille | |
France | Pfizer Investigational Site | Toulouse | |
Germany | Pfizer Investigational Site | Berlin | |
Germany | Pfizer Investigational Site | Mainz | |
Germany | Pfizer Investigational Site | Muenster | |
India | Pfizer Investigational Site | Ahmedabad | Gujarat |
India | Pfizer Investigational Site | Hyderabad | Andhra Pradesh |
India | Pfizer Investigational Site | Mangalore | Karnataka |
India | Pfizer Investigational Site | Nagpur | Maharashtra |
India | Pfizer Investigational Site | Pune | Maharashtra |
Latvia | Pfizer Investigational Site | Riga | |
Latvia | Pfizer Investigational Site | Riga | |
Mexico | Pfizer Investigational Site | Chihuahua | |
Mexico | Pfizer Investigational Site | Col. el Retiro | Guadalajara, Jal. |
Mexico | Pfizer Investigational Site | Col. Los Morales | Del Miguel, Hidalgo |
Mexico | Pfizer Investigational Site | Guadalajara, Jal | |
Mexico | Pfizer Investigational Site | Mexico City | Mexico D.F. |
Poland | Pfizer Investigational Site | Bielsk Podlaski | |
Poland | Pfizer Investigational Site | Krakow | |
Romania | Pfizer Investigational Site | Bucharest | |
Romania | Pfizer Investigational Site | Bucuresti | |
Romania | Pfizer Investigational Site | Bucuresti | |
Romania | Pfizer Investigational Site | Bucuresti | |
Romania | Pfizer Investigational Site | Cluj-Napoca | Cluj |
Romania | Pfizer Investigational Site | Iasi | |
Serbia | Pfizer Investigational Site | Belgrade | |
Serbia | Pfizer Investigational Site | Nis | |
Slovenia | Pfizer Investigational Site | Ljubljana | |
Spain | Pfizer Investigational Site | Alcala | |
Spain | Pfizer Investigational Site | Alcala de Henares | Madrid |
Spain | Pfizer Investigational Site | Madrid | |
Sweden | Pfizer Investigational Site | Uppsala | |
United Kingdom | Pfizer Investigational Site | Coventry | |
United Kingdom | Pfizer Investigational Site | Norwich | |
United States | Pfizer Investigational Site | Aurora | Colorado |
United States | Pfizer Investigational Site | Baltimore | Maryland |
United States | Pfizer Investigational Site | Birmingham | Alabama |
United States | Pfizer Investigational Site | Birmingham | Alabama |
United States | Pfizer Investigational Site | Brooklyn | New York |
United States | Pfizer Investigational Site | Charlotte | North Carolina |
United States | Pfizer Investigational Site | Denver | Colorado |
United States | Pfizer Investigational Site | Elmhurst | New York |
United States | Pfizer Investigational Site | Fort Wayne | Indiana |
United States | Pfizer Investigational Site | Indianapolis | Indiana |
United States | Pfizer Investigational Site | Kalamazoo | Michigan |
United States | Pfizer Investigational Site | Lebanon | New Hampshire |
United States | Pfizer Investigational Site | Memphis | Tennessee |
United States | Pfizer Investigational Site | New Brunswick | New Jersey |
United States | Pfizer Investigational Site | New Haven | Connecticut |
United States | Pfizer Investigational Site | Pinellas Park | Florida |
United States | Pfizer Investigational Site | Portage | Michigan |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
United States, Argentina, Australia, Brazil, Canada, Finland, France, Germany, India, Latvia, Mexico, Poland, Romania, Serbia, Slovenia, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered in combination with the SOC accelerates fracture union and return to normal function as indicated on radiographs and functional evaluations. | efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fra | No | |
Secondary | Demonstrate safety of rhBMP-2/CPM administration; demonstrate earlier return to function; assess feasibility of rhBMP-2CPM administration. Subject enrollment 12 months | 12 months | Yes |
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