| Background：Severe trauma, infection and bone tumor resection, often result in tissuedefect, bone defect repair is one of the orthopedic clinical problem. Autologous bone andallograft bone transplantation is the treatment of bone defects of the main methods, but allhave obvious shortcomings. Tissue engineering technology provides a new way for clinicalbone defect treatment of bone tissue engineering is applied to the clinical reports hasachieved satisfactory results, but the broader application field of tissue engineering boneand clinical use of bone tissue engineering for treating bone defects existing in the reportsof wide application, less number of clinical cases, follow-up time is short, the lack and thetraditional comparative study of bone graft material is not enough, so its long-term efficacyand safety of uncertainty limits its further clinical application.Objective：1. To evaluate the clinical efficacy of individualized tissue engineered bone inrepairing bone defect compare with allograft;2. To evaluate the biosafety of individualized tissue engineered bone.Methods：1. Twenty cases with fibrous dysplasia between September2004and September2009were reviewed retrospectively. Grouping: individualized tissue engineering bone (group A);Allogeneic bone (group B). Study: more than24months of follow-up record andperformed bone reconstruction cause by fibrous dysplasia. Clinical evaluation of indicators:(1) activities of daily living scale (ADLs);(2) Enneking limb function scoring standard;(3)imaging evaluation index of bone healing time, bone healing;(4) adverse reaction andcomplication rates. Biosafety of individualized tissue engineered bone assessment:(1) thevital signs and local general situation;(2) imaging and hematology continuous monitoringof the indicators. Follow-up: outpatient, letters and telephone follow-up. Comparative way:Each group comparison of preoperative and postoperative follow-up period, the same time period compared among the groups.2. Twenty-three cases with unicameral bone cyst between January2004and December2008were reviewed retrospectively. Grouping: individualized tissue engineering bone(group A); Allogeneic bone (group B). Study: more than24months of follow-up recordand performed bone reconstruction cause by unicameral bone cyst. Clinical evaluation ofindicators:(1) activities of daily living scale (ADLs);(2) Enneking limb function scoringstandard;(3) imaging evaluation index of bone healing time, bone healing;(4) adversereaction and complication rates. Biosafety of individualized tissue engineered boneassessment:(1) the vital signs and local general situation;(2) imaging and hematologycontinuous monitoring of the indicators. Follow-up: outpatient, letters and telephonefollow-up. Comparative way: Each group comparison of preoperative and postoperativefollow-up period, the same time period compared among the groups.Results：1. A group of10patients were followed up for63.6±19.6months,7males and3females, mean age14.3years; B group were followed up for10cases, follow-up time of55.1±15.4months,3males and7females, mean age23.8years. Long time follow-up twogroups can obtain good bone defect repair and healing time of group A (3.3±1.6) months,osseous healing score (2.6±0.5). Group B healing time (6.0±2.4) months, osseoushealing score (2.4±0.8). Between the two groups in function evaluation, complications andhealing score differences had no statistical significance (P>0.05); In terms of healing timedifference was statistically significant (P <0.05). Vital signs and blood group A contrast testresults preoperative and postoperative fluctuated slightly, but the indicators volatility has noobvious statistical difference, long time imaging observation found no recurrence andneoplasia, conform to the preoperative good prediction on the safety of bone tissueengineering.2. A group of11patients were followed up for67.5±26.8months,8males and3females, mean age13.7years; B group were followed up for12cases, follow-up time of43.4±19.6months,8males and4females, mean age12.9years. Long time follow-up twogroups can obtain good bone defect repair and healing time of group A (3.45±2.01) months.Group B healing time (6.75±3.31) months. Between the two groups in function evaluation,complications and healing score differences had no statistical significance (P>0.05); In terms of healing time difference was statistically significant (P <0.05). Vital signs andblood group A contrast test results preoperative and postoperative fluctuated slightly, but theindicators volatility has no obvious statistical difference, long time imaging observationfound no recurrence and neoplasia, conform to the preoperative good prediction on thesafety of bone tissue engineering.Conclusion：1. Compare with allograft, individualized tissue engineer bone have the superiorclinical curative effect in repairing bone defect.2. Individualized bone tissue engineering has strong biological safety. |
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