ACP for Local Application in Ankle Arthrodesis

Not Applicable

Terminated

• Conditions: Ankle Arthritis
• Interventions: Biological: Autologous Concentrated Plasma

• 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

Arm && Interventions

Group	Intervention	Description
Fusion+ACP+Autograft	Autologous Concentrated Plasma	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.
Fusion + ACP +DBM	Autologous Concentrated Plasma	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.

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