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NCT03371121 Clinical Trial

Clinical and Radiographic Outcomes After AMIC Treatment for Talus Osteochondral Lesion Trattamento Artroscopico Delle Lesioni Osteocondrali Dell'Astragalo Con Tecnica AMIC

Pain Clinical Trial

Official title:
Valutazione Dell'Epidemiologia e Dei Risultati Radiografici e Clinici Nel Trattamento Artroscopico Delle Lesioni Osteocondrali Dell'Astragalo Con Tecnica AMIC

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03371121
Other study ID # AMIC
Secondary ID
Status Recruiting
Phase N/A
First received December 7, 2017
Last updated December 7, 2017
Start date April 26, 2016
Est. completion date December 2028

Study information
Verified date December 2017
Source Istituto Ortopedico Galeazzi
Contact Federico G Usuelli, MD
Phone 00393357351838
Email fusuelli@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim of the study is to evaluate clinical and radiographic outcomes in patients undergone all-arthroscopic autologous matrix induced chondrogenesis for symptomatic osteochondral talar lesions

Recruitment information / eligibility
Status Recruiting
Enrollment 103
Est. completion date December 2028
Est. primary completion date February 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Age over 18 years

- males and females

- patients underwent arthroscopic cartilage reconstruction surgery with AMIC technique for osteochondral lesions of the talus

Exclusion Criteria:

- age <18 years at the time of surgery

- patients with previous surgery on the affected ankle

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)
to fill arthroscopically osteochondral talar lesion

Locations
Country Name City State
Italy Federico Usuelli Milan

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Radiologic reduction of the lesion A reduction of at least 30% of the lesion is to be expected 5 years
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