| OBJECTIVE:To compare the short-term and medium-term clinical effects between core decompression of femoral head combined with beta-tricalcium phosphate bioceramic rod and core decompression of femoral head combined with allogeneic bone in the treatment of early non-traumatic femoral head necrosisMETHODS:A retrospective analysis was made of 34 patients(39 hips)who were diagnosed as non-traumatic femoral head necrosis and underwent core decompression in the Affiliated Hospital of Yangzhou University from December 2014 to December 2016.According to the different implanted biomaterials after core decompression of femoral head,the patients were divided into observation group and control group.14 cases(16 hips)of the observation group were made of beta-tricalcium phosphate bioceramic rods,while 20 cases(23 hips)of the control group were made of allogenic bone.Collect basic data of patients,including gender,age,height and body mass index,course of disease,location of disease,ARCO stage and preoperative Harris score;Perioperative data included operation time,bleeding volume,number of C-arm X-ray machine perspective,hospitalization days and costs;Operative complications,including incision infection,immune rejection,subtrochanteric fracture of femur,deep venous thrombosis of lower extremity,etc;At 6 months,12 months and 24 months after operation,according to Harris score criteria(pain,function,range of motion and deformity)to evaluate the excellent and good rate(full score 100,excellent score 90-100,good score 80-89,70-79,poor score<70).Bilateral hip X-ray(positive and lateral)and hip MRI were taken at all follow-up time points to evaluate the overall shape of femoral head,necrosis extent of femoral head and absorption of implanted biomaterials.The survival rate of femoral head was assessed by end-point events.End-point event criteria:(1)Hip arthroplasty was performed after operation because of the gradual aggravation of hip pain and serious impact on daily life.(2)Postoperative recovery was unsatisfactory,walking was difficult,Harris score was less than 70,and hip arthroplasty was not performed.(3)Although the patient can tolerant various discomfort symptoms of the hip,however X-ray or MRI examination of the hip showed that the degree of femoral head necrosis had reached ARCO IV stage.SPSS 24.0 software was used for statistical analysis.The measurement data were expressed as mean±standard deviation(x±s),and the mean comparison between the two groups was performed by t-test;the counting data were expressed as percentage(%)and analyzed by X2test or corrected X2 test;the mean comparison among multiple groups was performed by variance analysis,and the mean comparison between any two groups of multiple samples was performed by SNK-q test;and the Kaplan-Meier survival curve was performed according to the end-point event criterion.All the values were reserved to the second decimal point.P<0.05 indicates that the difference has statistical significance,P<0.01 indicates that the difference has obvious statistical significance.RESULTS:1 Comparison of preoperative general data between the two groupsThe patients in the two groups were compared in terms of gender,age,body mass index,duration of disease,diseased area,ARCO stage,and preoperative Harris score.The difference was not statistically significant(P>0.05).2 Comparison of perioperative indicators between the two groupsThere were no significant differences in the operation time,bleeding volume,number of C-arm X-ray machine perspective,hospitalization days between the two groups(P>0.05).However,the hospitalization costs in observation group((23.14±4.91)thousand yuan)was significantly higher than that in control group((18.53±2.93)thousand yuan),(P>0.05),the difference was statistically significant(P<0.05).3 Comparison of Harris score at different time points in observation group3.1 The pain scores were compared at different time points(preoperative,6 months after operation,12 months after operation and 24 months after operation).The difference was statistically significant(Fpain=23.50,P<0.01).The scores of 6 months after operation(31.50±3.10),12 months after operation(36.64±2.50)and 24 months after operation(36.50±5.43)were significantly higher than those before operation(26.57±3.06).The difference was statistically significant(P<0.05).In addition,the pain score of 12 months after operation and 24 months after operation were significantly higher than that of 6 months after operation,and the difference was statistically significant(P<0.05).There was no significant difference in pain score between 12 months after operation and 24 months after operation(P>0.05).3.2 Functional score and joint activity score were compared at different time points(preoperative,6 months after operation,12 months after operation,24 months after operation),and the difference was statistically significant(Ffunctional=32.88,Fjoint activity =12.74,P<0.01).The scores of functional scores in 6 months after operation(39.36±2.4),12 months after operation(41.71±2.26)and 24 months after operation(40.35±3.77)were significantly higher than those before operation(31.64±3.08),the difference was statistically significant(P<0.05).The score of joint activity in 6 months after operation(4.64±0.50),12 months after operation(4.86±0.36)and 24 months after operation(4.64±0.74)were significantly higher than that before operation(3.50±0.85),the difference was statistically significant(P<0.05).There was no significant difference in functional score and joint activity score in 6 months after operation,12 months after operation and 24 months after operation(P>0.05)3.3 The limb deformity scores were compared at different time points(preoperative,6 months after operation,12 months after operation,24 months after operation).The results were similar,and there was no significant difference(P>0.05)4 Comparison of Harris score in control group at different time points4.1 The pain scores were compared at different time points(preoperative,6 months after operation,12 months after operation and 24 months after operation).The difference was statistically significant(Fpain=17.67,P<0.01).The pain scores at 6 months after operation(31.90±3.02),12 months after operation(35.50±2.46)and 24 months after operation(31.45±5.26)after operation were significantly higher than those before operation(26.85±3.74).The difference was statistically significant(P<0.05).The pain score of 12 months after operation was significantly higher than that of 6 months and 24 months after operation,and the difference was statistically significant(P<0.05).There was no significant difference in pain score between 6 months after operation and 24 months after operation(P>0.05).4.2 Functional scores were compared at different time points(preoperative,6 months after operation,12 months after operation,24 months after operation).The difference was statistically significant(Ffunctional=41.25,P<0.01).Functional score increased significantly in 6 months after operation(39.15±2.36),12 months after operation(40.65±3.08)and 24 months after operation(38.35±3.39)compared with that before operation(31.10±2.90).The difference was statistically significant(P<0.05).In addition,the functional scores at 12 months after operation were significantly higher than those at 6 months and 24 months after operation(P<0.05).There was no significant difference in functional score between 6 months after operation and 24 months after operation(P>0.05).4.3 Joint activity scores were compared at different time points(preoperative,6 months after operation,12 months after operation,24 months after operation).The difference was statistically significant(Fjoint activity=10.58,P<0.01).The score of joint activity in 6 months after operation(4.55±0.51),12 months after operation(4.75±0.44)and 24 months after operation(4.45±0.82)were significantly higher than that before operation(3.55±0.98).The difference was statistically significant(P<0.05).There was no significant difference in joint activity score between 6 months after operation,12 months after operation and 24 months after operation(P>0.05).4.4 The limb deformity scores were compared at different time points(preoperative,6 months after operation,12 months after operation,24 months after operation).The results were similar,and there was no significant difference(P>0.05).5 Comparison of Harris score and excellent and good rate between two groups at different time points after operation5.1 At 24 months after operation,the pain and function scores in the observation group[(36.50±5.43)and(40.35±3.77)were significantly higher than those in the control group[(31.45±5.26)and(38.35±3.39)].The difference was statistically significant(P<0.05).There was no significant difference in joint activity and limb score between the two groups(P>0.05).There was no significant difference in pain,function,range of motion of joints and scores of limb deformities between the two groups at 6 months and 12 months after operation(P>0.05).5.2 At 24 months after operation,the total Harris score and the excellent and good rate of Harris score in the observation group[(85.00±10.40)and(93.75)%]were significantly higher than those in the control group[(77.7±9.65)and(52.17)%].The difference was statistically significant(P<0.05).The Harris score and the excellent and good rate of the two groups at 6 months and 12 months after operation were similar,there was no significant difference between the two groups(P<0.05).6 Comparison of survival rates between the two groupsAt the end of the last follow-up,there were 3 cases(3 hips)in the observation group and 7 cases(7 hips)in the control group.Kaplan-Meier survival analysis was used to analyze the survival rate of femoral head in the two groups.The results showed that the survival rate of the observation group(78.60%)was significantly higher than that of the control group(65.00%).The difference was statistically significant(P<0.05).CONCLUSION:The short-term efficacy of beta-tricalcium phosphate bioceramic rod or allogenic bone combined with core decompression of femoral head in the treatment of early non-traumatic femoral head necrosis is similar,while the mid-term follow-up results show that beta-tricalcium phosphate bioceramic rod is superior to allogenic bone.As a new bone repair material,the long-term efficacy of beta-tricalcium phosphate bioceramic rod in the treatment of non-traumatic femoral head necrosis remains to be further observed. |
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