Completed

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.

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What is being tested

HYTOP®

Device
Who is being recruted

From 18 to 50 Years
+32 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2014
See protocol details

Summary

Principal SponsorTRB Chemedica AG
Last updated: November 21, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2014

Actual date on which the first participant was enrolled.

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.

NCT01791062
Principal SponsorTRB Chemedica AG
Last updated: November 21, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

12 inclusion criteria required to participate
Cartilage defect classified as Outerbridge grade 3 or 4
Chondral lesions not exceeding through the subchondral bone (intact subchondral bone)
Clinical symptoms in the target joint (pain on walking 100 m of more than 4 on an 11-point numerical scale or swelling or locking or 'giving way')
Corresponding joint area classified with maximum Outerbridge grade 2
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20 exclusion criteria prevent from participating
Cartilage lesion is not intact shouldered, has bipolar or corresponding involvement or bipolar 'kissing' lesions
Forbidden concomitant treatment affecting the evaluation of study parameters (e.g. oral intake of chondroitin sulfate, glucosamine, piascledine, other i.a. treatments like depot corticosteroids or arthroscopic procedures)
Infection at study relevant site
Inflammatory joint diseases (e.g. rheumatoid arthritis, Bechterew disease, chondromatosis)
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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

Osnabrück, GermanyOpen Klinikum Osnabrück GmbH Finkenhügel, Klinik für Orthopädie, Unfall- und Handchirurgie in Google Maps
CompletedOne Study Center