ACP for Local Application in Ankle Arthrodesis

Ankle Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01131455
• Other study ID #: ARTH-0071
• 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

• Ankle Arthritis

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