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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.

journal_name

Cartilage

journal_title

Cartilage

authors

Vanlauwe J,Huylebroek J,Van Der Bauwhede J,Saris D,Veeckman G,Bobic V,Victor J,Almqvist KF,Verdonk P,Fortems Y,Van Lommel N,Haazen L

doi

10.1177/1947603511430325

subject

Has Abstract

pub_date

2012-04-01 00:00:00

pages

173-80

issue

eissn

1947-6035

issn

1947-6043

pii

10.1177_1947603511430325

journal_volume

pub_type

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Clinical Outcomes of Characterized Chondrocyte Implantation.