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

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.

Study Overview

• Status: Unknown
• Conditions: Degenerative Lesion of Articular Cartilage of Knee; Osteochondral Lesion of Talus
• Intervention / Treatment: Device: implantation of MaioRegen fleece into osteochondral lesion

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• multiple osteochondral lesions
• pre-existing injuries/arthropathies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: osteochondral lesions in knee/ankle; 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; arthroscopic localization of lesion, arthroscopic guided mini-arthrotomy and implantation of defect sized MaioRegen fleece; Other Names: MaioRegen Fin-Ceramica Faenza S.p.A.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI imaging - gap between cartilage-implant surface in mm	ingrowth of fleece into the cartilage	18 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical outcome measurement	Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index	pre-surgery
clinical outcome measurement	Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index	6 months post-surgery
clinical outcome measurement	Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index	12 months post-surgery
clinical outcome measurement	Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index	18 months post-surgery
clinical outcome measurement	Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index	24 months post-surgery

Collaborators and Investigators

• Sponsor: Barmherzige Brüder Eisenstadt
• Investigators: Principal Investigator: Richard Kellner, MD, Barmherzige Brueder Eisenstadt; Study Chair: Harald Boszotta, MD, Barmherzige Brueder Eisenstadt

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: September 11, 2014
• First Submitted That Met QC Criteria: January 19, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Estimate): July 22, 2015
• Last Update Submitted That Met QC Criteria: July 21, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: BBEMaRe 001