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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Autologous Concentrated Plasma | Autologous 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.