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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01131455
Other study ID # ARTH-0071
Secondary ID
Status Terminated
Phase N/A
First received May 26, 2010
Last updated November 12, 2014
Start date October 2009
Est. completion date July 2010

Study information

Verified date November 2014
Source Columbia Orthopaedic Group, LLP
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- patients whom present the need for the elective surgery

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Columbia Orthopedic Group Columbia Missouri

Sponsors (1)

Lead Sponsor Collaborator
Columbia Orthopaedic Group, LLP

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary CT Scan for Fusion Analysis There will be no outcome analysis for the CT scan performed on the 10 patients due to the death of the primary investigator. 8 weeks post op. No
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