ACP for Local Application in Ankle Arthrodesis

NCT01131455 | Terminated Results

• 1 other identifier: ARTH-0071
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ankle Arthritis

Outcome Measures

Primary Outcomes (1)

• CT Scan for Fusion Analysis

  There will be no outcome analysis for the CT scan performed on the 10 patients due to the death of the primary investigator.

  8 weeks post op.

Study Arms (3)

Fusion+ACP+Autograft

ACTIVE COMPARATOR

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

Fusion + ACP +DBM

ACTIVE COMPARATOR

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

Standard-Fusion +Autograft only

NO INTERVENTION

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.

Interventions

Autologous Concentrated Plasma BIOLOGICAL

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.

Also known as: ACP

Fusion + ACP +DBM; Fusion+ACP+Autograft

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients whom present the need for the elective surgery

You may not qualify if:

• None

Sponsors & Collaborators

• Columbia Orthopaedic Group, LLP: lead

Study Sites (1)

Columbia Orthopedic Group

Columbia, Missouri, 65201, United States

Location

Results Point of Contact

• Title: Vicki L Jones, Research Coordinator
• Organization: ColumbiaOG

v.jones@columbiaorthogroup.com

573-443-2402

Study Officials

• Paul Shurnas

  Columbia Orthopaedic Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sr. Research Coordinator

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 27, 2010
• Study Start: October 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 13, 2014
• Results First Posted: November 13, 2014

Record last verified: 2014-11

Locations

US (1)