Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2009-10-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Columbia Orthopaedic Group, LLP
OTHER
Responsible Party
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Vicki L Jones
Sr. Research Coordinator
Principal Investigators
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Paul Shurnas
Role: PRINCIPAL_INVESTIGATOR
Columbia Orthopaedic Group
Locations
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Columbia Orthopedic Group
Columbia, Missouri, United States
Countries
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Other Identifiers
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ARTH-0071
Identifier Type: -
Identifier Source: org_study_id