Clinical and Radiological Results of Osteochondral Repair Using MaioRegen in Knee and Ankle Surgery

Not Applicable

• Conditions: Osteochondral Lesion of Talus; Degenerative Lesion of Articular Cartilage of Knee
• Interventions: Device: implantation of MaioRegen fleece into osteochondral lesion

• Registration Number: NCT02345564
• Lead Sponsor: Barmherzige Brüder Eisenstadt

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2015-01-19
• Study First Posted: 2015-01-26
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-21
• Last Update Posted: 2015-07-22
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

• multiple osteochondral lesions
• pre-existing injuries/arthropathies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
MRI imaging - gap between cartilage-implant surface in mm	18 months post surgery	ingrowth of fleece into the cartilage

Secondary Outcome Measures

Name	Time	Method
clinical outcome measurement	24 months post-surgery	Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot\&Ankle Disability Index