Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
Summary
To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study [RUS]); and 4) rate of fracture displacement. The primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the SOC control group.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Radius Fractures
Intervention
rhBMP-2/CPM
Location
Kuopio
Finland
70211
Status
Completed
Source
Wyeth
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00161629
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Femoral Neck Fractures
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.
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).
Skull 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).
Astigmatism
Unequal curvature of the refractive surfaces of the eye. Thus a point source of light cannot be brought to a point focus on the retina but is spread over a more or less diffuse area. This results from the radius of curvature in one plane being longer or shorter than the radius at right angles to it. (Dorland, 27th ed)
Clinical Trials
A Study of rhBMP-2/CPM in Closed Fractures of the Humerus
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...
Feasibility and Safety Study of rhBMP-2/CPM for Fractures of the Proximal Femur
The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.
Metaphyseal Distal Radius Fractures
The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniqu...
The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with distal radius fractures treated with open red...
The purpose of this study is to compare to ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.
PubMed Articles
Objective: To report the successful use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the treatment of an antebrachial non-union, secondary to gunshot fracture, stabilized with circul...
BACKGROUND: The functional outcome of surgically treated dislocated fractures of the distal radius is limited and does not correlate with radiographic results. Additional carpal lesions are assumed to...
Malunion of the distal radius.
Fractures of the distal radius are extremely common injuries, which are steadily becoming a public health issue. One of the most common complications following distal radius fractures is still malunio...
Arthroscopy-assisted management of wrist fractures.
Distal radius fractures are the most common fractures in humans and early surgical intervention with modern plating systems is becoming increasingly more established to avoid secondary dislocation. Ev...
Treatment of unstable distal radius fractures with the volar locking plate.
Abstract Background. Open reduction and internal fixation using an interlocking plate system has gained popularity for the treatment of dorsally displaced distal radius fractures. Purpose. To evaluate...
