ACP for Local Application in Ankle Arthrodesis
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ClinicalTrials.gov Identifier: NCT01131455 |
Recruitment Status
:
Terminated
(Study was terminated due to the untimely death of the investigator)
First Posted
: May 27, 2010
Results First Posted
: November 13, 2014
Last Update Posted
: November 13, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ankle Arthritis | Biological: Autologous Concentrated Plasma | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Autologous Concentrated Platelet-rich Plasma (Arthrex ACP®) for Local Application in Ankle Arthrodesis: A Prospective Outcome Analysis. |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | July 2010 |
Arm | Intervention/treatment |
---|---|
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.
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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
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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
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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.
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- CT Scan for Fusion Analysis [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients whom present the need for the elective surgery
Exclusion Criteria:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131455
United States, Missouri | |
Columbia Orthopedic Group | |
Columbia, Missouri, United States, 65201 |
Principal Investigator: | Paul Shurnas | Columbia Orthopaedic Group |
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 |
First Posted: | May 27, 2010 Key Record Dates |
Results First Posted: | November 13, 2014 |
Last Update Posted: | November 13, 2014 |
Last Verified: | November 2014 |