Study Stopped
Enrollment suspended; follow up continue
ChonDux for Filling Full Thickness Cartilage Defects in the Femoral Condyle of the Knee
Pivotal Study in Europe for CE Mark
1 other identifier
interventional
21
3 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2010
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2010
CompletedFirst Posted
Study publicly available on registry
April 26, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJuly 7, 2017
July 1, 2017
5 months
April 22, 2010
July 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Defect fill at 6 months determined by magnetic resonance imaging (MRI)
6 months
Secondary Outcomes (3)
Pain score (VAS)
6 months
Knee function as assessed by the IKDC questionnaire
6 months
SF-36 Health Survey
6 months
Study Arms (2)
ChonDux plus microfracture
EXPERIMENTALMicrofracture
ACTIVE COMPARATORInterventions
Comparison of ChonDux plus microfracture to microfracture only
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (7)
Medalp
Imst, Austria
Ortho.Abteilung, AKH Linz
Linz, Austria
Krakenhaus Altentreptow
Altentreptow, Germany
Orthopedic and Pain Center Freiberg
Freiberg, Germany
University Mannheim
Mannheim, Germany
Meander Medical Center
Baarn, Netherlands
Tergooiziekenhuizen
Hilversum, Netherlands
Related Publications (1)
Wolf MT, Zhang H, Sharma B, Marcus NA, Pietzner U, Fickert S, Lueth A, Albers GHR, Elisseeff JH. Two-Year Follow-Up and Remodeling Kinetics of ChonDux Hydrogel for Full-Thickness Cartilage Defect Repair in the Knee. Cartilage. 2020 Oct;11(4):447-457. doi: 10.1177/1947603518800547. Epub 2018 Oct 3.
PMID: 30280586DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2010
First Posted
April 26, 2010
Study Start
July 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2012
Last Updated
July 7, 2017
Record last verified: 2017-07