A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures

Phase 3TerminatedNCT00387686

Wyeth is now a wholly owned subsidiary of Pfizer367 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

367

Conditions

Fractures

Interventions

rhBMP-2/CPMDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (68)

Outcomes

Primary Outcomes

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.

Time frame: efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fra

Secondary Outcomes

Demonstrate safety of rhBMP-2/CPM administration; demonstrate earlier return to function; assess feasibility of rhBMP-2CPM administration. Subject enrollment 12 months

Time frame: 12 months

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Aurora, Colorado, United States

Pfizer Investigational Site

Denver, Colorado, United States

Pfizer Investigational Site

New Haven, Connecticut, United States

Pfizer Investigational Site

Pinellas Park, Florida, United States

Pfizer Investigational Site

Fort Wayne, Indiana, United States

Pfizer Investigational Site

Indianapolis, Indiana, United States

Pfizer Investigational Site

Baltimore, Maryland, United States

Pfizer Investigational Site

Kalamazoo, Michigan, United States

...and 58 more locations