title: Clinical Outcomes of Characterized Chondrocyte Implantation.
abstract: OBJECTIVE
  To assess the clinical outcome of patients treated with autologous chondrocyte implantation using ChondroCelect in daily practice.
  
  
  METHODS
  The study is a cross-sectional analysis of an open-label, noninterventional cohort. The setting was a compassionate use program, involving 43 orthopaedic centers in 7 European countries. The participants were patients treated with ChondroCelect between October 13, 2004 and July 2, 2008. The measurements used were Clinical Global Impression-Improvement and -Efficacy and solicited adverse event reports.
  
  
  RESULTS
  Safety data were collected from 334 patients (90.3%), and effectiveness data were from 282 (76.2%) of the 370 patients treated. Mean age at baseline was 33.6 years (range, 12-57 years), 57% were male, and mean body mass index was 25 kg/m(2). Mean follow-up was 2.2 years (range, 0.4-4.1 years). A femoral condyle lesion was reported in 66% (288/379) and a patellar lesion in 19% (84/379). Mean lesion size was 3.5 cm(2); a collagen membrane was used in 92.4% (328/355). A therapeutic effect was reported in 89% (234/264) of patients overall and in 87% (40/46) of patellar lesion patients. Rates of much or very much improved patients were similar in patients with short- (<18 months: 71% [115/163]) and long-term follow-up (>18 months: 68% [70/103]) (P = 0.68) and were independent of lesion size (>4 cm(2): 75.5% [37/49]; ≤4 cm(2): 67.7% [111/164]) (P = 0.38). Adverse events were similar to those reported in the randomized trial with the same product, with more arthrofibrosis, more reduced joint mobility, and more crepitations reported in patellar lesions. Overall, less cartilage hypertrophy was noted, probably due to the use of a biological membrane cover.
  
  
  CONCLUSIONS
  Implantation of ChondroCelect appeared to result in a positive benefit/risk ratio when used in an unselected heterogenous population, irrespective of the follow-up period, lesion size, and type of lesion treated.
authors.affiliation: University Hospitals Leuven, Pellenberg, Belgium.
authors.forename: Johan
authors.initials: J
authors.lastname: Vanlauwe
authors.affiliation: Hôpital Parc Léopold, Groupe Chirec, Brussels, Belgium.
authors.forename: José
authors.initials: J
authors.lastname: Huylebroek
authors.affiliation: Community Hospital AZ Groeninge, Kortrijk, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Van Der Bauwhede
authors.affiliation: University Medical Centre UMC Utrecht, Utrecht, the Netherlands.
authors.forename: Daniël
authors.initials: D
authors.lastname: Saris
authors.affiliation: Community Hospital AZ Jan Palfijn, Ghent, Belgium.
authors.forename: Geert
authors.initials: G
authors.lastname: Veeckman
authors.affiliation: The Grosvenor Hospital Chester, Chester, United Kingdom.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Bobic
authors.affiliation: University Hospitals Gent, Ghent, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Victor
authors.affiliation: University Hospitals Gent, Ghent, Belgium.
authors.forename: Karl Fredrik
authors.initials: KF
authors.lastname: Almqvist
authors.affiliation: "Stedelijk Ziekenhuis" Community Hospital, Roeselare, Belgium.
authors.forename: Peter
authors.initials: P
authors.lastname: Verdonk
authors.affiliation: Community Hospital AZ St Augustinus, Wilrijk, Belgium.
authors.forename: Yves
authors.initials: Y
authors.lastname: Fortems
authors.affiliation: Tigenix NV, Leuven, Belgium.
authors.forename: Nel
authors.initials: N
authors.lastname: Van Lommel
authors.affiliation: Envision bvba, Leuven, Belgium.
authors.forename: Ludo
authors.initials: L
authors.lastname: Haazen
keywords: ACI; ChondroCelect; autologous; chondrocyte implantation; clinical; patella