MedTrace Logo

Safety and Efficacy Study of HYTOP® in the Treatment of Focal Chondral Defects.

NCT01791062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2016-11-21

No results posted yet for this study

Summary

The two-layer bioresorbable HYTOP® matrix consists of an upper layer of highly purified porcine splint-skin which contains natural pores, and a lower layer of highly purified collagen fleece containing hyaluronan (HA).

In this study, the medical device will be used and evaluated in a one-step procedure combining microfracturing with surgical implantation of HYTOP®. HYTOP® will support haemostasis in the articular cartilage defect, act as a support for cell growth and as a three-dimensional scaffold for cell differentiation. HYTOP® will protect the underlying tissue after cartilage debridement and/or microfracturing of the subchondral bone.

The primary working hypothesis is that HYTOP® is safe and suitable as a cell-free matrix to support haemostasis, as a cover for the cartilage lesion and eventually to enhance cartilage regeneration in a one-step surgical procedure.

Conditions

  • Focal Chondral Defect in Femoro-tibial Compartment of the Knee Joint

Interventions

DEVICE

HYTOP®

HYTOP® will be implanted once during surgery.

Sponsors & Collaborators

  • TRB Chemedica AG

    lead INDUSTRY

Principal Investigators

  • Martin Engelhardt, Dr. · Klinikum Osnabrück GmbH Finkenhügel, Klinik für Orthopädie, Unfall- und Handchirurgie, Osnabrück (Germany)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01791062 on ClinicalTrials.gov