ACP for Local Application in Ankle Arthrodesis

Not Applicable

Terminated

• Conditions: Ankle Arthritis

• Registration Number: NCT01131455
• Lead Sponsor: Columbia Orthopaedic Group, LLP

Brief 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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-27
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2014-07-29
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-12
• Last Update Submitted: 2014-11-12
• Results First Posted: 2014-11-13
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• patients whom present the need for the elective surgery

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CT Scan for Fusion Analysis	8 weeks post op.	There will be no outcome analysis for the CT scan performed on the 10 patients due to the death of the primary investigator.

Trial Locations

Locations (1)

Columbia Orthopedic Group; 🇺🇸 Columbia, Missouri, United States