NCT03371121

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Apr 2016Dec 2028

Study Start

First participant enrolled

April 26, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
9.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

2.8 years

First QC Date

December 7, 2017

Last Update Submit

December 7, 2017

Conditions

Talar Osteochondral Defect of AnklePainArthroscopy

Outcome Measures

Primary Outcomes (1)

  • Radiologic reduction of the lesion

    A reduction of at least 30% of the lesion is to be expected

    5 years

Study Arms (1)

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

AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)OTHER

to fill arthroscopically osteochondral talar lesion

Chondro-gide - Geistlich

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years
  • males and females
  • patients underwent arthroscopic cartilage reconstruction surgery with AMIC technique for osteochondral lesions of the talus

You may not qualify if:

  • age \<18 years at the time of surgery
  • patients with previous surgery on the affected ankle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico Usuelli

Milan, 20161, Italy

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Federico G Usuelli, MD

    IRCCS Istituto Ortopedico Galeazzi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico G Usuelli, MD

CONTACT

00393357351838fusuelli@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 13, 2017

Study Start

April 26, 2016

Primary Completion

February 1, 2019

Study Completion (Estimated)

December 1, 2028

Last Updated

December 13, 2017

Record last verified: 2017-12

Locations

IT(1)