A Study of rhBMP-2/CPM in Closed Fractures of the Humerus

Wyeth is now a wholly owned subsidiary of Pfizer139 enrolled

Overview

The primary objective of this study is to assess whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

139

Conditions

Fractures

Interventions

rhBMP-2/CPMDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Skeletally mature subjects age 18 years or older. * Subjects with either a closed proximal humeral fracture or a diaphyseal humeral fracture. * Treatment plan that includes only conservative (nonoperative) therapy within 48 hours following injury. Exclusion Criteria: * Shoulder dislocation at the time of injury. * Planned procedure(s) at that would stimulate fracture union at the time of application of the initial immobilization device. * Fractures located in the distal third of humerus.

Locations (37)

Unnamed facility

Outcomes

Primary Outcomes

The primary efficacy variable in this study is radiographic union.

Time frame: Fracture union is assessed at 4, 6, 8, 10, 12, 16, 26 and 52 week visits. The goal of acceleration of fracture union will be met if median time to radiographic fracture union is decreased by 4 weeks in an active treatment arm compared to SOC alone.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.