| ObjectiveTo evaluate the preliminary clinical efficacy of 3D printed cervical porous metal mesh cage for the treatment of cervical degenerative diseases.MethodsThe clinical data of this study was derived from the clinical trial of 3D printed cervical porous metal mesh cage which was conducted by the First Affiliated Hospital of University of South China.The program name is A multi-center,randomized,single-blind,positive parallel control clinical trial for the effectiveness and safety evaluation of 3D printed cervical porous metal mesh cages for the treatment of cervical degeneration.The clinical trial was designed using a multicenter,randomized,single-blind,positive parallel control,non-inferior trial.The five centersinclude the First Affiliated Hospital of South China,the First Affiliated Hospital of Zhengzhou University,Taihe Hospital of Shiyan City,Chenzhou NO.1 People's Hospital,and PUAI Hospital of Wuhan City.There was 108 cases with 54 cases in the experimental group and t control group.The subjects were randomly assigned to the experimental group and the control group according to 1:1.The experimental group used the 3D printed cervical porous metal mesh cage produced by Hunan Huaxiang Incremental Manufacturing Co.Ltd;the control product used was traditional cervical titanium mesh cage produced by Changzhou Kanghui Medical Devices Co.Ltd.(Registration No.: National Machinery Note 20173460990).The clinical trial follows the Helsinki Declaration and relevant regulations related to clinical trial research in China.The clinical trial was approved by ethics committee before start the trail.and the 3D printed cervical vertebrae porous metal mesh cage used in this study also has passed the medical device quality inspection by the State Food and Drug Administration of China.As March 14,2019,there was 18 cases(12 males and 6 females)in our department had 6 months follow up with an average age of 56 years(range,44-69 years).9 patients(6 males and 3 females)in the experimental group with an average age of 55 years(44-69 years),and 9 patients(6 males and 3 females)in the control group with an average age of 58 years(45-64).Postoperative follow up included cervical X-ray and cervical three-dimensional CT.Postoperative interbody height,C2-7 Cobb angle,fusion segment Cobb angle,JOA score,neck pain VAS score of preoperative,postoperative,3 months postoperative and 6 months postoperative and fusion rate of 6 months postoperative were analysed to do a preliminary clinical study of the 3D printed cervical vertebrae porous mesh cage.ResultsAs of March 14,2019,the medical device clinical trial of 3D printed cervical porous metal mesh cage with 108 patients has been completed,include 48 cases in the First Affiliated Hospital of South China,18 cases in the First Affiliated Hospital of Zhengzhou University,26 cases in Taihe Hospital of Shiyan City,10 cases in the Chenzhou NO.1 People's Hospital,and 6 cases in PUAI Hospital of Wuhan City.As March 14,2019,there was 18 cases had 6 months follow up in our department with an 9 in the experimental group and 9 in the control group.There were no significant differences in age and gender between the two groups(P>0.05).At 6 months after surgery,no patients in the experimental group had subsidence(0%),and 4 patients in the control group had subsidence(44%).There was a statistically significant difference at cage subsidence between the two groups(P<0.05).At 6 months postoperative,9 cases(100%)of bone graft fusion criteria were obtained in experimental group,and 5 cases(56%)of bone graft fusion criteria were obtained in the control group.The fusion rate of bone grafting has statistically diffrernce(P<0.05).The C2-7 Cobb angle of the experimental group at preoperative,postoperative,3 months postoperative and 6 months postoperative was 15.76±11.00°,11.92±13.87°,18.27±13.04°,and 22.36±13.36°;The C2-7 Cobb angle of control group at preoperative,postoperative,3 months postoperative and 6 months postoperative was 13.60±19.09°,15.43±16.15°,22.04±17.74° and 17.00±16.71°.There was no significant difference at C2-7 Cobb angel between the two groups in the same follow-up period(P>0.05).The fusion segment Cobb angle of experimental group at preoperative,postoperative,3 months postoperative and 6 months postoperative was 2.91±8.01°,7.90±6.44°,7.43±6.21°,and 7.89±8.03°;The fusion segment Cobb angle of control group at preoperative,postoperative,3 months postoperative and 6 months postoperative was 7.85±10.18°,8.64±10.60°,11.25±10.89°,and 7.14±10.18°.There was no significant difference in fusion segment Cobb angle between the two groups in the same follow-up period(P>0.05).The difference of fusion segment Cobb angle of experimental group between postoperative and preoperative was 4.99±5.53°,the difference of fusion segment Cobb angle of experimental group between 6 months postoperative and postoperative was-0.01±5.27°;The difference of fusion segment Cobb angle of control group between postoperative and preoperative was 0.79±7.72°,The difference of fusion segment Cobb angle of control group between 6 months postoperative and postoperative was-1.50±4.48°.There was no significant difference in fusion segment Cobb angle between two groups at preoperative and 6 months postoperative(P>0.05).The JOA score of experimental group at preoperative,postoperative,3 months postoperative and 6 months postoperative was 9.33±3.16 points,9.33±3.16 points,12.89±1.36 points and 15.78±0.97 points;The JOA score of control group at preoperative,postoperative,3 months postoperative and 6 months postoperative 9.11±2.47 points,was 9.11±2.47 points,13.11±1.36 points,and 15.89±0.60 points.The neck pain VAS score in the experimental group at preoperative,postoperative,3 months postoperative and 6 months postoperative was 2.67±1.00 points,2.11±0.33 points,1.33±0.50 points,and 1.22±0.44 points;The neck pain VAS score in the control group at preoperative,postoperative,3 months postoperative and 6 months postoperative was 3.33±0.87 points,2.33±0.71 points,1.11±0.33 points,and 1.56±0.53 points.There was no significant difference in the JOA score and neck pain VAS score between the two groups at the same time point(P>0.05).The JOA improvement rate was 81.90±17.62% in the experimental group and 83.80±10.09% in the control group.There was no significant difference in the JOA improvement rate between the experimental group and the control group at 6 months after operation(P>0.05).There were no cases of subsidence in the experimental group,so the correlation between the cage subsidence and the distraction distance was only analyzed in the control group.There was no correlation between the cage subsidence and the distraction distance in the control group.ConclusionThe early case data of this clinical trial suggest that the 3D printed cervical porous metal mesh cage has a lower incidence of subsidence and a higher bone graft fusion rate than the traditional cervical titanium mesh,and there is no significant difference in the observed clinical efficacy indicatous. |
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