NCT02345564

Brief Summary

Osteochondral lesions in knee and ankle are injuries commonly seen in young patients. MaioRegen fleece is a cartilage substitute which can be used in circumscribed defects. This prospective study follows patients treated with MaioRegen implants from pre-surgery until 24 months post-surgery.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

3.8 years

First QC Date

September 11, 2014

Last Update Submit

July 21, 2015

Conditions

Osteochondral Lesion of TalusDegenerative Lesion of Articular Cartilage of Knee

Outcome Measures

Primary Outcomes (1)

  • MRI imaging - gap between cartilage-implant surface in mm

    ingrowth of fleece into the cartilage

    18 months post surgery

Secondary Outcomes (5)

  • clinical outcome measurement

    pre-surgery

  • clinical outcome measurement

    6 months post-surgery

  • clinical outcome measurement

    12 months post-surgery

  • clinical outcome measurement

    18 months post-surgery

  • clinical outcome measurement

    24 months post-surgery

Study Arms (1)

osteochondral lesions in knee/ankle

OTHER

patients with traumatic and atraumatic osteochondral lesions in knee/ankle, implantation of MaioRegen fleece into osteochondral lesion

Device: implantation of MaioRegen fleece into osteochondral lesion

Interventions

implantation of MaioRegen fleece into osteochondral lesionDEVICE

arthroscopic localization of lesion, arthroscopic guided mini-arthrotomy and implantation of defect sized MaioRegen fleece

Also known as: MaioRegen Fin-Ceramica Faenza S.p.A.
osteochondral lesions in knee/ankle

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • single osteochondral lesion in knee/ankle (2-4 sq cm)

You may not qualify if:

  • multiple osteochondral lesions
  • pre-existing injuries/arthropathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Richard Kellner, MD

    Barmherzige Brueder Eisenstadt

    PRINCIPAL INVESTIGATOR

  • Harald Boszotta, MD

    Barmherzige Brueder Eisenstadt

    STUDY CHAIR

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

September 11, 2014

First Posted

January 26, 2015

Study Start

March 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 22, 2015

Record last verified: 2015-07