The use of tissue engineering for cartilage repair hasemerged as a potential therapeutic option and has led to thedevelopment of Hyalograft C, a tissue-engineered graftcomposed of autologous chondrocytes grown on a scaffoldentirely made of HYAFF 11, an esterified derivative of hyaluronicacid. Here we present the results of an ongoingmulticenter clinical study conducted with the primary objectiveto investigate the subjective symptomatic, functional andhealth-related quality of life outcomes of patients treatedwith Hyalograft C. Clinical results on the cohort of 141patients with followup assessments ranging from 2 to 5 years(average followup time: 38 months), are reported. At followup91.5% of patients improved according to the InternationalKnee Documentation Committee subjective evaluation;76% and 88% of patients had no pain and mobilityproblems respectively assessed by the EuroQol-EQ5D measure.Furthermore, 95.7% of the patients had their treatedknee normal or nearly normal as assessed by the surgeon;cartilage repair was graded arthroscopically as normal ornearly normal in 96.4% of the scored knees; the majority ofthe second-look biopsies of the grafted site histologicallywere assessed as hyalinelike. Importantly, a very limitedcomplication rate was recorded in this study. The positiveclinical results obtained indicate that Hyalograft C is a safeand effective therapeutic option for the treatment of articularcartilage lesions.
Articular Cartilage Engineering with Hyalograft® C. 3 Years Clinical Results
KON, ELIZAVETA;Marcacci, Maurilio
2005-01-01
Abstract
The use of tissue engineering for cartilage repair hasemerged as a potential therapeutic option and has led to thedevelopment of Hyalograft C, a tissue-engineered graftcomposed of autologous chondrocytes grown on a scaffoldentirely made of HYAFF 11, an esterified derivative of hyaluronicacid. Here we present the results of an ongoingmulticenter clinical study conducted with the primary objectiveto investigate the subjective symptomatic, functional andhealth-related quality of life outcomes of patients treatedwith Hyalograft C. Clinical results on the cohort of 141patients with followup assessments ranging from 2 to 5 years(average followup time: 38 months), are reported. At followup91.5% of patients improved according to the InternationalKnee Documentation Committee subjective evaluation;76% and 88% of patients had no pain and mobilityproblems respectively assessed by the EuroQol-EQ5D measure.Furthermore, 95.7% of the patients had their treatedknee normal or nearly normal as assessed by the surgeon;cartilage repair was graded arthroscopically as normal ornearly normal in 96.4% of the scored knees; the majority ofthe second-look biopsies of the grafted site histologicallywere assessed as hyalinelike. Importantly, a very limitedcomplication rate was recorded in this study. The positiveclinical results obtained indicate that Hyalograft C is a safeand effective therapeutic option for the treatment of articularcartilage lesions.File | Dimensione | Formato | |
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