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

This study has been terminated.
(Enrollment suspended; follow up continue)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01110070
First received: April 22, 2010
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Cartilage Defect
Device: ChonDux

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pivotal Study in Europe for CE Mark

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Defect fill at 6 months determined by magnetic resonance imaging (MRI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain score (VAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Knee function as assessed by the IKDC questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • SF-36 Health Survey [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: July 2010
Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ChonDux plus microfracture Device: ChonDux
Comparison of ChonDux plus microfracture to microfracture only
Active Comparator: Microfracture Device: ChonDux
Comparison of ChonDux plus microfracture to microfracture only
Device: ChonDux
single use device

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110070

Locations
Austria
Medalp
Imst, Austria
Ortho.Abteilung, AKH Linz
Linz, Austria
Germany
Krakenhaus Altentreptow
Altentreptow, Germany
Orthopedic and Pain Center Freiberg
Freiberg, Germany
University Mannheim
Mannheim, Germany
Netherlands
Meander Medical Center
Baarn, Netherlands
Tergooiziekenhuizen
Hilversum, Netherlands
Sponsors and Collaborators
Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01110070     History of Changes
Other Study ID Numbers: CCS-08
Study First Received: April 22, 2010
Last Updated: July 17, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Biomet, Inc.:
articular
cartilage
microfracture
knee pain
cartilage repair
Subjects with an articular cartilage defect in the knee.

ClinicalTrials.gov processed this record on August 21, 2014