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

Osteochondral Lesion of Talus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02345564
• Other study ID #: BBEMaRe 001
• Status: Active, not recruiting
• Phase: N/A
• First received: September 11, 2014
• Last updated: July 21, 2015
• Start date: March 2012
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: Barmherzige Brüder Eisenstadt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• multiple osteochondral lesions

• pre-existing injuries/arthropathies

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Lesion of Articular Cartilage of Knee
• Osteochondral Lesion of Talus

Intervention

Device:
• implantation of MaioRegen fleece into osteochondral lesion
arthroscopic localization of lesion, arthroscopic guided mini-arthrotomy and implantation of defect sized MaioRegen fleece

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Barmherzige Brüder Eisenstadt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI imaging - gap between cartilage-implant surface in mm	ingrowth of fleece into the cartilage	18 months post surgery	No
Secondary	clinical outcome measurement	Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index	pre-surgery	No
Secondary	clinical outcome measurement	Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index	6 months post-surgery	No
Secondary	clinical outcome measurement	Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index	12 months post-surgery	No
Secondary	clinical outcome measurement	Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index	18 months post-surgery	No
Secondary	clinical outcome measurement	Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index	24 months post-surgery	No