ACP for Local Application in Ankle Arthrodesis

This study has been terminated.

(Study was terminated due to the untimely death of the investigator)

Sponsor:

Information provided by (Responsible Party):

Vicki L Jones, Columbia Orthopaedic Group, LLP

ClinicalTrials.gov Identifier:

NCT01131455

First received: May 26, 2010

Last updated: November 12, 2014

Last verified: November 2014

History of Changes

Purpose

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

Condition	Intervention
Ankle Arthritis	Biological: Autologous Concentrated Plasma


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Autologous Concentrated Platelet-rich Plasma (Arthrex ACP®) for Local Application in Ankle Arthrodesis: A Prospective Outcome Analysis.

Further study details as provided by Columbia Orthopaedic Group, LLP:

Primary Outcome Measures:

CT Scan for Fusion Analysis [ Time Frame: 8 weeks post op. ] [ Designated as safety issue: No ]
There will be no outcome analysis for the CT scan performed on the 10 patients due to the death of the primary investigator.


Enrollment:	10
Study Start Date:	October 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Fusion+ACP+Autograft Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.	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. Other Name: ACP
Active Comparator: Fusion + ACP +DBM Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.	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. Other Name: ACP
No Intervention: Standard-Fusion +Autograft only Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.

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.

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients whom present the need for the elective surgery

Exclusion Criteria:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131455

Locations


United States, Missouri
Columbia Orthopedic Group
Columbia, Missouri, United States, 65201

Sponsors and Collaborators

Columbia Orthopaedic Group, LLP

Investigators


Principal Investigator:	Paul Shurnas	Columbia Orthopaedic Group

More Information


Responsible Party:	Vicki L Jones, Sr. Research Coordinator, Columbia Orthopaedic Group, LLP
ClinicalTrials.gov Identifier:	NCT01131455 History of Changes
Other Study ID Numbers:	ARTH-0071
Study First Received:	May 26, 2010
Results First Received:	July 29, 2014
Last Updated:	November 12, 2014
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 28, 2016

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