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Safety and Efficacy Study of HYTOP® in the Treatment of Focal Chondral Defects. | Clinical Trials | Clareo Health

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

Safety and Efficacy of a Novel, Cell-free Cartilage Repair Construct in the Treatment of Focal Chondral Defects Involving the Femoro-tibial Compartment of the Knee Joint.

NCT01791062•TRB Chemedica AG

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female patients between 18 and 50 years of age.
•Good general health condition.
•Signed written informed consent.
•General anaesthesia is justifiable for the patient from the medical point of view.
•Focal chondral defects involving the femorotibial compartment of the knee joint localised in only one compartment and not larger than the size of one HYTOP® patch.
•Isolated one-sided chondral lesion.
•Cartilage defect classified as Outerbridge grade 3 or 4.
•Chondral lesions not exceeding through the subchondral bone (intact subchondral bone).
•Nearly intact chondral structure surrounding the defect, specifically Outerbridge grade 2 or less.
•Corresponding joint area classified with maximum Outerbridge grade 2.
+2 more criteria

Exclusion Criteria

•Treatment with any investigational product within 4 weeks prior to study entry.
•Patients with known hypersensitivity to the constituents of the product or any component or procedure used in the study.
•Patients with previous treatment of the study relevant defect site.
•Cartilage lesion is not intact shouldered, has bipolar or corresponding involvement or bipolar 'kissing' lesions.
•Necessity of cartilage repair treatment at bilateral joints.
•Patients with meniscus lesions, total or partial (more than 1/3 of total volume) resected meniscus, limited joint mobility, varus/valgus joint malalignment of more than 5 degrees or insufficient ligament support.
•Inflammatory joint diseases (e.g. rheumatoid arthritis, Bechterew disease, chondromatosis).
•Infection at study relevant site.
•Osteoarthritis, arthrofibrosis or haematopoetic related diseases.
•Study relevant metabolic disease, adipositas (BMI equal to or greater 30 kilogram per square meter).
+10 more criteria

Locations (1)

Klinikum Osnabrück GmbH Finkenhügel, Klinik für Orthopädie, Unfall- und Handchirurgie

Osnabrück, Lower Saxony, Germany

Key Dates

Start Date

February 1, 2014

Primary Completion Date

October 1, 2016

Completion Date

October 1, 2016

Last Updated

November 21, 2016

Enrollment

ACTUAL participants

Conditions

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

Interventions

HYTOP®

DEVICE