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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02345564
Enrollment
15
Registered
2015-01-26
Start date
2012-03-31
Completion date
2015-12-31
Last updated
2015-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEimplantation of MaioRegen fleece into osteochondral lesion

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

Sponsors

Barmherzige Brüder Eisenstadt
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* multiple osteochondral lesions * pre-existing injuries/arthropathies

Design outcomes

Primary

MeasureTime frameDescription
MRI imaging - gap between cartilage-implant surface in mm18 months post surgeryingrowth of fleece into the cartilage

Secondary

MeasureTime frameDescription
clinical outcome measurementpre-surgeryLysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026