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

Cartilage Defect Clinical Trial

Official title:

Pivotal Study in Europe for CE Mark

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01110070
• Other study ID #: CCS-08
• Status: Terminated
• Phase: N/A
• First received: April 22, 2010
• Last updated: July 6, 2017
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cartilage Defect

Intervention

Device:
• ChonDux
Comparison of ChonDux plus microfracture to microfracture only
• ChonDux
single use device

Locations

Country	Name	City	State
Austria	Medalp	Imst
Austria	Ortho.Abteilung, AKH Linz	Linz
Germany	Krakenhaus Altentreptow	Altentreptow
Germany	Orthopedic and Pain Center Freiberg	Freiberg
Germany	University Mannheim	Mannheim
Netherlands	Meander Medical Center	Baarn
Netherlands	Tergooiziekenhuizen	Hilversum

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defect fill at 6 months determined by magnetic resonance imaging (MRI)		6 months
Secondary	Pain score (VAS)		6 months
Secondary	Knee function as assessed by the IKDC questionnaire		6 months
Secondary	SF-36 Health Survey		6 months