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

Zimmer Biomet21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cartilage Defect

Interventions

ChonDuxDEVICE

Comparison of ChonDux plus microfracture to microfracture only

ChonDuxDEVICE

single use device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (7)

Medalp

Imst, Austria

Ortho.Abteilung, AKH Linz

Linz, Austria

Krakenhaus Altentreptow

Altentreptow, Germany

Orthopedic and Pain Center Freiberg

Freiberg, Germany

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Pain score (VAS)

Time frame: 6 months

Knee function as assessed by the IKDC questionnaire

Time frame: 6 months

SF-36 Health Survey

Time frame: 6 months

Data from ClinicalTrials.gov

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