Matthew T Wolf1,2,3, Hong Zhang1,4, Blanka Sharma5, Norman A Marcus6, Uwe Pietzner7, Stefan Fickert8,9, Achim Lueth10, G H Robert Albers11,12, Jennifer H Elisseeff1,2,3. 1. Translational Tissue Engineering Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 2. Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 3. Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University, Baltimore, MD, USA. 4. Department of Chemical and Biomolecular Engineering, Johns Hopkins University, Baltimore, MD, USA. 5. J. Crayton Pruitt Family Department of Biomedical Engineering, University of Florida, Gainesville, FL, USA. 6. Virginia Cartilage Institute, Springfield, VA, USA. 7. Department of Arthroscopic Surgery and Sport Traumatology, Clinic for Orthopedics and Trauma Surgery, Dietrich-Bonhoeffer-Klinikum Neubrandenburg, Altentreptow, Germany. 8. Sporthopaedicum Straubing Berlin Regensburg, Straubing, Germany. 9. University Medical Centre Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany. 10. Praxisclinic Zaehringen, Department of Orthopedics, Freiburg, Germany. 11. AVE Orthopedic Clinics, Huizen, Netherlands. 12. Abteilung Orthopaedie/Unfallchirurgie, Diakonissenkrankenhaus, Schladming, Austria.
Abstract
OBJECTIVE: To determine performance and repair kinetics of the ChonDux hydrogel scaffold for treating focal articular cartilage defects in the knee over 24 months. DESIGN: This assessor-blinded trial evaluates ChonDux hydrogel scaffold implantation in combination with microfracture in 18 patients across 6 sites. Male and female patients 18 to 65 years of age with full-thickness femoral condyle defects 2 to 4 cm2 in area were enrolled. Eligible patients received ChonDux treatment followed by rehabilitation. Defect volume fill was evaluated after 3, 6 (primary outcome), 12, 18, and 24 months by assessor blinded magnetic resonance imaging (MRI) analysis. Secondary outcomes were T2-weighted MRI relaxation time and patient surveys via visual analogue scale (VAS) pain and International Knee Documentation Committee (IKDC) knee function scoring. RESULTS: ChonDux maintained durable tissue restoration over 24 months with final defect percent fill of 94.2% ± 16.3% and no significant loss of fill volume at any time points. Tissues treated with ChonDux maintained T2 relaxation times similar to uninjured cartilage between 12 and 24 months. VAS pain scoring decreased between 1 and 6 weeks, and IKDC knee function scores improved by approximately 30.1 with ChonDux over 24 months. CONCLUSION: ChonDux treatment is a safe adjunct to microfracture therapy and promotes stable restoration of full thickness articular cartilage defects for at least 24 months.
OBJECTIVE: To determine performance and repair kinetics of the ChonDux hydrogel scaffold for treating focal articular cartilage defects in the knee over 24 months. DESIGN: This assessor-blinded trial evaluates ChonDux hydrogel scaffold implantation in combination with microfracture in 18 patients across 6 sites. Male and female patients 18 to 65 years of age with full-thickness femoral condyle defects 2 to 4 cm2 in area were enrolled. Eligible patients received ChonDux treatment followed by rehabilitation. Defect volume fill was evaluated after 3, 6 (primary outcome), 12, 18, and 24 months by assessor blinded magnetic resonance imaging (MRI) analysis. Secondary outcomes were T2-weighted MRI relaxation time and patient surveys via visual analogue scale (VAS) pain and International Knee Documentation Committee (IKDC) knee function scoring. RESULTS: ChonDux maintained durable tissue restoration over 24 months with final defect percent fill of 94.2% ± 16.3% and no significant loss of fill volume at any time points. Tissues treated with ChonDux maintained T2 relaxation times similar to uninjured cartilage between 12 and 24 months. VAS pain scoring decreased between 1 and 6 weeks, and IKDC knee function scores improved by approximately 30.1 with ChonDux over 24 months. CONCLUSION: ChonDux treatment is a safe adjunct to microfracture therapy and promotes stable restoration of full thickness articular cartilage defects for at least 24 months.
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