TY - JOUR
T1 - Articular cartilage engineering with Hyalograft® C
T2 - 3-Year clinical results
AU - Marcacci, Maurilio
AU - Berruto, Massimo
AU - Brocchetta, Domenico
AU - Delcogliano, Antonio
AU - Ghinelli, Diego
AU - Gobbi, Alberto
AU - Kon, Elizaveta
AU - Pederzini, Luigi
AU - Rosa, Donato
AU - Sacchetti, Gian Luigi
AU - Stefani, Giacomo
AU - Zanasi, Stefano
PY - 2005/6
Y1 - 2005/6
N2 - The use of tissue engineering for cartilage repair has emerged as a potential therapeutic option and has led to the development of Hyalograft® C, a tissue-engineered graft composed of autologous chondrocytes grown on a scaffold entirely made of HYAFF® 11, an esterified derivative of hyaluronic acid. Here we present the results of an ongoing multicenter clinical study conducted with the primary objective to investigate the subjective symptomatic, functional and health-related quality of life outcomes of patients treated with Hyalograft® C. Clinical results on the cohort of 141 patients with followup assessments ranging from 2 to 5 years (average followup time: 38 months), are reported. At followup 91.5% of patients improved according to the International Knee Documentation Committee subjective evaluation; 76% and 88% of patients had no pain and mobility problems respectively assessed by the EuroQol-EQ5D measure. Furthermore, 95.7% of the patients had their treated knee normal or nearly normal as assessed by the surgeon; cartilage repair was graded arthroscopically as normal or nearly normal in 96.4% of the scored knees; the majority of the second-look biopsies of the grafted site histologically were assessed as hyalinelike. Importantly, a very limited complication rate was recorded in this study. The positive clinical results obtained indicate that Hyalograft® C is a safe and effective therapeutic option for the treatment of articular cartilage lesions. Level of Evidence: Therapeutic study, Level HI-2 (retrospective cohort study).
AB - The use of tissue engineering for cartilage repair has emerged as a potential therapeutic option and has led to the development of Hyalograft® C, a tissue-engineered graft composed of autologous chondrocytes grown on a scaffold entirely made of HYAFF® 11, an esterified derivative of hyaluronic acid. Here we present the results of an ongoing multicenter clinical study conducted with the primary objective to investigate the subjective symptomatic, functional and health-related quality of life outcomes of patients treated with Hyalograft® C. Clinical results on the cohort of 141 patients with followup assessments ranging from 2 to 5 years (average followup time: 38 months), are reported. At followup 91.5% of patients improved according to the International Knee Documentation Committee subjective evaluation; 76% and 88% of patients had no pain and mobility problems respectively assessed by the EuroQol-EQ5D measure. Furthermore, 95.7% of the patients had their treated knee normal or nearly normal as assessed by the surgeon; cartilage repair was graded arthroscopically as normal or nearly normal in 96.4% of the scored knees; the majority of the second-look biopsies of the grafted site histologically were assessed as hyalinelike. Importantly, a very limited complication rate was recorded in this study. The positive clinical results obtained indicate that Hyalograft® C is a safe and effective therapeutic option for the treatment of articular cartilage lesions. Level of Evidence: Therapeutic study, Level HI-2 (retrospective cohort study).
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U2 - 10.1097/01.blo.0000165737.87628.5b
DO - 10.1097/01.blo.0000165737.87628.5b
M3 - Article
C2 - 15930926
AN - SCOPUS:20444396510
SN - 0009-921X
SP - 96
EP - 105
JO - Clinical Orthopaedics and Related Research
JF - Clinical Orthopaedics and Related Research
IS - 435
ER -