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

NCT ID: NCT02345564

Last Updated: 2015-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteochondral Lesion of Talus Degenerative Lesion of Articular Cartilage of Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

osteochondral lesions in knee/ankle

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

Group Type OTHER

implantation of MaioRegen fleece into osteochondral lesion

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

implantation of MaioRegen fleece into osteochondral lesion

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MaioRegen Fin-Ceramica Faenza S.p.A.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* multiple osteochondral lesions
* pre-existing injuries/arthropathies
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Barmherzige BrĂ¼der Eisenstadt

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard Kellner, MD

Role: PRINCIPAL_INVESTIGATOR

Barmherzige Brueder Eisenstadt

Harald Boszotta, MD

Role: STUDY_CHAIR

Barmherzige Brueder Eisenstadt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BBEMaRe 001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.