Clinical Trials Directory

Trials / Terminated

TerminatedNCT01131455

ACP for Local Application in Ankle Arthrodesis

Autologous Concentrated Platelet-rich Plasma (Arthrex ACP®) for Local Application in Ankle Arthrodesis: A Prospective Outcome Analysis.

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Columbia Orthopaedic Group, LLP · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

To compare the outcomes of patients who undergo three different types of surgeries for ankle fusion and reconstruction.

Detailed description

It is understood that an elevated concentration of platelets in the mix of the arthrodesis construct applied intra-operatively to the bony surface, has osteo-generating and enhanced wound healing properties. With that knowledge there is a clinical need and enthusiasm for the application of concentrated platelets, which release a large quantity of growth factors to encourage recovery in non healing injuries or surgical sites. This study represents an effort to more clearly define the true clinical outcomes with or without biologic enhancement, and fulfills a need for fortifying evidence concerning the efficacy of ACP in live human bone healing-- based on radiographic and CT scans.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAutologous Concentrated PlasmaAutologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use.

Timeline

Start date
2009-10-01
Primary completion
2010-07-01
Completion
2010-07-01
First posted
2010-05-27
Last updated
2014-11-13
Results posted
2014-11-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01131455. Inclusion in this directory is not an endorsement.