Clinical and Radiographic Outcomes After AMIC Treatment f... | NCT03371121

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

NCT03371121

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status

Recruiting

Last Update Posted

Dec 13, 2017Actual

Enrollment

103Estimated

Phase

Not Applicable

Conditions

Talar Osteochondral Defect of Ankle
Pain
Arthroscopy

Interventions

AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 26, 2016Actual

Primary Completion Date

Feb 2019Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Dec 7, 2017

First Submission Date that Met QC Criteria

Dec 7, 2017

First Posted Date

Dec 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2017

Last Update Posted Date

Dec 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

103Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chondro-gide - Geistlich	Other	Arthroscopic use of chondro-gide to treat symptomatic osteochondral talar lesion	Other: AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)	Other	to fill arthroscopically osteochondral talar lesion	Chondro-gide - Geistlich

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiologic reduction of the lesion	A reduction of at least 30% of the lesion is to be expected	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Federico G Usuelli, MD	Contact	00393357351838		fusuelli@gmail.com

Overall Officials

Name	Affiliation	Role
Federico G Usuelli, MD	IRCCS Istituto Ortopedico Galeazzi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federico Usuelli	Recruiting	Milan		20161	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms