Articular cartilage engineering with Hyalograft C: 3-year clinical results.
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 hyaline-like. 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.


METHODS
Therapeutic study, Level III-2 (retrospective cohort study). See the Guidelines for Authors for a complete description of levels of evidence.
Marcacci
Maurilio
M
Istituti Ortopedici Rizzoli, Laboratorio di Biomeccanica, Via Di Barbiano 1/10, 40136 Bologna, Italy.
Berruto
Massimo
M
Brocchetta
Domenico
D
Delcogliano
Antonio
A
Ghinelli
Diego
D
Gobbi
Alberto
A
Kon
Elisaveta
E
Pederzini
Luigi
L
Rosa
Donato
D
Sacchetti
Gian Luigi
GL
Stefani
Giacomo
G
Zanasi
Stefano
S
D000328:Adult; D001672:Biocompatible Materials; D002358:Cartilage, Articular / Q000601:surgery*; D019902:Chondrocytes / Q000637:transplantation*; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000031:analogs & derivatives* / Q000494:pharmacology*; D007718:Knee Injuries / Q000601:surgery*; D008297:Male; D008592:Menisci, Tibial / Q000601:surgery*; D011788:Quality of Life; D016059:Range of Motion, Articular; D012189:Retrospective Studies; D018709:Statistics, Nonparametric; D000070600:Tibial Meniscus Injuries; D023822:Tissue Engineering / Q000379:methods*; D016896:Treatment Outcome
D001672:Biocompatible Materials; C086358:hyaluronic acid benzyl ester; D006820:Hyaluronic Acid