Clinical trial NCT01110070: ChonDux for Filling Full Thickness Cartilage Defects in the Femoral Condyle of the Knee
Official title: Pivotal Study in Europe for CE Mark
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cartilage Defect
Keywords: articular
cartilage
microfracture
knee pain
cartilage repair
Subjects with an articular cartilage defect in the knee.
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2010-04-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Defect fill at 6 months determined by magnetic resonance imaging (MRI)
timeFrame: 6 months
Secondary outcomes:
measure: Pain score (VAS)
timeFrame: 6 months
measure: Knee function as assessed by the IKDC questionnaire
timeFrame: 6 months
measure: SF-36 Health Survey
timeFrame: 6 months
Other outcomes:
Locations:
city: Imst
country: Austria
facility: Medalp
city: Linz
country: Austria
facility: Ortho.Abteilung, AKH Linz
city: Altentreptow
country: Germany
facility: Krakenhaus Altentreptow
city: Freiberg
country: Germany
facility: Orthopedic and Pain Center Freiberg
city: Mannheim
country: Germany
facility: University Mannheim
city: Baarn
country: Netherlands
facility: Meander Medical Center
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen
Study officials:
References:
citation: 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.