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

2014-07-23 21:35:11 | BioPortfolio

Summary

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 Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Fractures

Intervention

rhBMP-2/CPM

Location

Little Rock
Arkansas
United States
72205

Status

Completed

Source

Wyeth

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:35:11-0400

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Medical and Biotech [MESH] Definitions

Fractures of the short, constricted portion of the thigh bone between the femur head and the trochanters. It excludes intertrochanteric fractures which are HIP FRACTURES.

Fractures of the FEMUR HEAD; the FEMUR NECK; (FEMORAL NECK FRACTURES); the trochanters; or the inter- or subtrochanteric region. Excludes fractures of the acetabulum and fractures of the femoral shaft below the subtrochanteric region (FEMORAL FRACTURES).

Fractures of the skull which may result from penetrating or nonpenetrating head injuries or rarely BONE DISEASES (see also FRACTURES, SPONTANEOUS). Skull fractures may be classified by location (e.g., SKULL FRACTURE, BASILAR), radiographic appearance (e.g., linear), or based upon cranial integrity (e.g., SKULL FRACTURE, DEPRESSED).

Crumbling or smashing of cancellous BONE by forces acting parallel to the long axis of bone. It is applied particularly to vertebral body fractures (SPINAL FRACTURES). (Blauvelt and Nelson, A Manual of Orthopedic Terminology, 1994, p4)

Fractures due to the strain caused by repetitive exercise. They are thought to arise from a combination of MUSCLE FATIGUE and bone failure, and occur in situations where BONE REMODELING predominates over repair. The most common sites of stress fractures are the METATARSUS; FIBULA; TIBIA; and FEMORAL NECK.

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