ChonDux for Filling Full Thickness Cartilage Defects in the Femoral Condyle of the Knee

Pivotal Study in Europe for CE Mark

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01110070

Enrollment

Registered

2010-04-26

Start date

2010-07-31

Completion date

2012-12-31

Last updated

2017-07-07

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

Conditions

Cartilage Defect

Keywords

articular, cartilage, microfracture, knee pain, cartilage repair, Subjects with an articular cartilage defect in the knee.

Brief summary

The use of ChonDux Cartilage Repair system for the treatment of single cartilage lesions in the femoral condyle of the knee. The primary outcome measure is degree of lesion fill at 6 months. Filling of the femoral chondral defect of the knee using ChonDux™ Cartilage System may give symptomatic relief of pain and help to restore knee function. Included in this study is pain relief using Visual Analog Scale (VAS), knee function using the International Knee Documentation Committee (IKDC) questionnaire and quality of life using the Short Form-36 (SF-36) survey.

Detailed description

Current treatment approaches for articular cartilage defects have been disappointing and clinical results have been variable. However, when using crosslinked hydrogel technologies, in vitro findings have shown chondrocyte growth and extra-cellular matrix (ECM) production supportive of cartilage production.

Interventions

DEVICEChonDux

Comparison of ChonDux plus microfracture to microfracture only

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* A standing radiograph of the knee showing a Kellgren score of 0-2 * Body mass index ≤33 * An Outerbridge score of III or IV without need for bone graft * A meniscus with no more than partial resection in the affected knee

Exclusion criteria

* Passive motion deficit of the knee (\>5º of extension, \>15º of flexion) * Moderate or severe osteoarthritis * Diabetes mellitus (IDDM Type 1) * Patellofemoral instability * Malalignment with \> 5° valgus or varus compared to contralateral knee * Active osteomyelitis

Design outcomes

Primary

Measure	Time frame
Defect fill at 6 months determined by magnetic resonance imaging (MRI)	6 months

Secondary

Measure	Time frame
Pain score (VAS)	6 months
Knee function as assessed by the IKDC questionnaire	6 months
SF-36 Health Survey	6 months

Countries

Austria, Germany, Netherlands

Outcome results

None listed

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