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: January 28, 2014
Last verified: January 2014
  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 ]

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients whom present the need for the elective surgery

Exclusion Criteria:

  • None
  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

No publications provided

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
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014