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

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ClinicalTrials.gov Identifier: NCT03371121
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Brief 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

Condition or disease Intervention/treatment Phase
Talar Osteochondral Defect of Ankle Pain Arthroscopy Other: AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 103 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Valutazione Dell'Epidemiologia e Dei Risultati Radiografici e Clinici Nel Trattamento Artroscopico Delle Lesioni Osteocondrali Dell'Astragalo Con Tecnica AMIC
Actual Study Start Date : April 26, 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : December 2028

Arm Intervention/treatment
Chondro-gide - Geistlich
Arthroscopic use of chondro-gide to treat symptomatic osteochondral talar lesion
Other: AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)
to fill arthroscopically osteochondral talar lesion




Primary Outcome Measures :
  1. Radiologic reduction of the lesion [ Time Frame: 5 years ]
    A reduction of at least 30% of the lesion is to be expected



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT03371121


Contacts
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Contact: Federico G Usuelli, MD 00393357351838 fusuelli@gmail.com

Locations
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Italy
Federico Usuelli Recruiting
Milan, Italy, 20161
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
Investigators
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Principal Investigator: Federico G Usuelli, MD IRCCS Istituto Ortopedico Galeazzi
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Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03371121    
Other Study ID Numbers: AMIC
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No