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

Wyeth

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Fractures

Treatments: Drug: rhBMP-2/CPM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00387686

3100N7-210

Details and patient eligibility

About

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.

Enrollment: 367 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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367 participants in 4 patient groups

A

Experimental group

Description:

1.0 mg/mL rhBMP-2/CPM + surgical fixation

Treatment:

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM

B

Experimental group

Description:

2.0 mg/mL rhBMP-2/CPM + surgical fixation

Treatment:

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM

C

Active Comparator group

Description:

Buffer/CPM + surgical fixation Intervention

Treatment:

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM

D

Other group

Description:

Standard of Care: Surgical fixation intervention

Treatment:

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM