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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cartilage Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ChonDux plus microfracture

Group Type EXPERIMENTAL

ChonDux

Intervention Type DEVICE

Comparison of ChonDux plus microfracture to microfracture only

Microfracture

Group Type ACTIVE_COMPARATOR

ChonDux

Intervention Type DEVICE

Comparison of ChonDux plus microfracture to microfracture only

ChonDux

Intervention Type DEVICE

single use device

Interventions

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ChonDux

Comparison of ChonDux plus microfracture to microfracture only

Intervention Type DEVICE

ChonDux

single use device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No