OSTEOARTHRITIS CARTILAGE - Crespine Gel

156 Listrat et al.: Hyaluronan in osteoarthritis of the kneeTable IBaseline characteristics of the 39 patients suffering from knee osteoarthritis enrolledin the studyCharacteristicsDemographic dataAge (years) (mean, s.o.)Sex (F/M)Body mass index (kg/m'z) (mean, s.o.)OA characteristicsDisease duration (years)(man, s.o., range)Synovial fluid effusion (yes/no)Number of joints effected by OA(mean, s.n., range)Concomitant NSAiD therapyduring the previous 6 months(number of patients)*Statisticalsignifi cance determined by thefor the quantitative variables and by thevariables. NS = not significant.Treatment groupHyaluronanN= 2060+711/927.5 + 3.84(0-26)rol202.6 + 7-7(1-6)11ControlN= 19 P-value*64+8r5l426.6 + 3.6(0-15)10/192.6 + t.2(1-5)1lNSNSNSNSNSNSNSnonparametric Mann-Whitney U testChi-square test for the qualitativeStatistical analysisStatistical analyses were performed to compareby treatment group the baseline characteristics ofpatients and the changes which occurred in theclinical, radiologicai and arthroscopical variablesduring the study. For the continuous efficacyparameters, the anaiysis of covariance (ANCOVA)using the conesponding baseline (week 0) assessmentas the covariate was performed. Categoricalvariables were analyzed by chi-square test. Allstatistical tests for the efficacy variables wereperformed two-sided with a level of significancea = 0.05.Arthroscopic parameters have been chosen asthe a priori primary efficacy variables. However, atthe time the protocoi was designed, no particularscale had been chosen. In this manuscript, wereport the statistical analyses concerning the threearthroscopic parameters, i.e., the overall assessmentof chondropathy using a 100 mm length VAS,the SFA scoring system, the SFA grading system.Some additional analyses were performed on theeffect of concomitant therapy. NSAID treatmentcould potentially interact with progression of thestructural disease [35] and NSAID intake mightdepend on the efficacy of the study treatment (i.e.,the higher the treatment effect, the lower theexpected NSAID intake). Due to the lack ofindependence between the effect of the trearmenrand the need for concomitant treatments, onlyexploratory analyses were carried out. The aims ofthese analyses were to study the main effect ofNSAID intake on outcome and the effect of theinteraction between this variable and trcatment onoutcome.Table IISymptomatic seuerity of knee osteoarthritis by treatment groups in the 36 patients who completed. the I year stud.yEntry visit Final visit Difference from baselineClinical variablesPain(VAS, mm)Functional impairementLequesneLs indexQuality of lifeAIMS,(roral of t2 irems)*ANCOVAanalysis.HyaluronanN= 1949.2 + 20.18.9 + 4-12.6 + 1.3ControlN= 17HyaluronanN= 1952.1 + 16.8 32.4 + 25.59.4 + 3.5 7.2 + 4.8ControlN=77HyaluronanN= 19ControlN= 17 P-va]ue*46.8 + 27.7 -16.8 + 23.9 -5.2 + 36.6 0.13*8.1 + 4.1 -1.7 + 2.g -1.4 + 5.9 0.66*2.2 + 0.7 2.2 + r.3 2.4 + 7.1 -0.42 + 0.67 +0.18+ 0.88 0.047*