Autologous Transfusion Or Drain After6Hours’ Clamping?Influence On Post-TKA Impactions

BackgroundOsteoarthritis (OA), as a common joint disease, which leads to disability is the second highest incidence over the age of50-year-old, frequently-occurring disease affecting the health of the elderly. With modern artificial joint replacement technology maturity, as well as our country people’s economic life level enhancement, accept total knee arthroplasty (TKA) treatment of end-stage joint disease patients increased year by year.Total knee arthroplastyis a high technical requirements, larger orthopaedic trauma surgery, because of intraoperatie requires a lot of knee bone cutting and stripping of soft tissue in order to realize the flexion gap of balance, these procedures are often cause a lot of wounds. Although intraoperatie generally use a tourniquet, intraoperative hemorrhage is less, but, once a tourniquet release, postoperative surgical area instead of the circulation of the blood more than other surgery, blood loss and faster speed. Therefore, in the surgery under the premise of make a lot of wounds, bleeding often significantly increased, at the same time, accompanied by swelling and pain and other postoperative complications.In order to avoid the articular cavity large hematoma formation, influence of incision healing and increase the risk of infection, clinical traditional countermeasures is joint cavity drainage tube placement, to dredge the hemorrhage, the prevention of incision hematoma formation, thus reducing the poor wound healing, scar adhesion in a knee joint, and complications such as infection. However, the traditional Closed Suction Drainage (CSD) way neither reduce Drainage, also lack of Drainage recycling back to lose blood, therefore, is not conducive to reducing the postoperative blood loss. Using CSD patients, postoperative often require more allogeneic blood infusion quantity.The choices of the strategies for TKA surgery improved drainage, academia has been controversial. Literature reported that a number of improvement programs, mainly including autologous blood transfusion and promote wound clotting two technical approaches. Is through postoperative patients with incision drainage of liquid filtered back directly or diluted to go back to lose, by making the drainage of the fluid in the blood cells back into the blood circulation, thus reducing the actual blood loss, less acute blood loss anemia and its sequelae caused by such purposes; The latter by direct temporary clamping drainage tube or intramuscular injection of epinephrine into articular cavity at the same time, make the joint cavity hemorrhage accumulation formation pressure, formation of wound blood vessels hematoma filling and pressure effect, namely "hematoma tamponade effect", to promote the joint cavity of wound clotting and reduce the purpose of drain.The first application of the drainage of the "hematoma tamponade effect" was in1988by Sakihara and other scholars. The scheme at the end of surgery, to the joint cavity perfusion through drainage tube dilution of adrenaline, and clamping drainage tube1hour, through drug hemostatic and joint cavity temporary high pressure effect, prompting wound clotting articular cavity, so as to realize the purpose of reduce lead flow. However, Yamada and other scholars found that drugs such as adrenaline can lead to skin edge necrosis and lower limb Deep Vein Thrombosis (DVT). In addition, the clinical practice found articular cavity and high pressure condition, the drainage fluid leakage along the skin fistula, unfavorable to care. In order to avoid the side effects of adrenaline, Prasad and other scholars put forward simple clamp drainage tube, and extend to24hours after the open plan, aims to extend the clamping the drainage tube time, get a more precise hemostasis effect. However, because of drainage fluid can not be effective, it may increase the probability of the incision infection was found.Autologous blood transfusion program is through the use of autologous blood transfusion system, which use of vacuum negative pressure attraction to collect, filter and recovery of blood cells back to patients. Sinha and other scholars study shows that by this scheme, you can make60%～80%of drainage fluid return to the circulation of the blood, thus substantially reduce blood loss. Although this program can minimize the articular cavity hemorrhage, articular cavity adhesion, infection and scar formation potential complications. However, in order to maximize emptying the solution must use the vacuum negative pressure attraction, high negative pressure attraction will increase the bleeding wound, it will inevitably increase the incision led traffic. At the same time, due to the limited blood recover, and some of the red blood cells in the process of filtering suffers damage, leading to recovery of red blood cells return soon after the circulation of the blood by the spleen removed, Marks and some scholars study found that the scheme does not materially reduce postoperative blood loss, and can not effectively reduce amount of allogeneic blood transfusion and blood transfusion rate.Visible, whether clamping tube solution, the drainage tube or autologous blood transfusion, are to varying degrees has disadvantages. Therefore, in view of the above two kinds of flaws of the drainage scheme, based on the traditional drainage tube clamping scheme proposed joint cavity infusion drugs, not directly clamping6hours after open to compromise. Clamping6hours is designed based on Senthil-Kumar and other scholar’s research results. Senthil-Kumar and other scholars report after TKA surgery postoperative blood loss occurs mainly in the initial few hours (within2hours after surgery, blood loss accounts for37%to55%occurred within4hours after surgery,78%occurred within6hours) after surgery. Clamping may be considered as the6hours can maximize both reduce postoperative drainage and avoid DVT and avoid long clamp caused by the drainage of liquid deposition and increase the infection rate and complications in avoiding complications and no adrenaline drainage scheme on the basis of the realization of decreased blood loss after TKA.ObjectivesThis research attempts to see by comparing the improved clamping tube6hours in reducing postoperative drainage, total blood loss and allogeneic blood transfusion rate and volume of blood transfusion, the incidence of DVT, limb swelling degree, range of motion of the knee, incision infection rate and difference between autologous blood transfusion scheme, aimed at looking for a can both reduce for total knee replacement postoperative drainage and prevent postoperative complications of improved drainage scheme.Methods1、MaterialsFrom March2011to March2012,91patients with primary osteoarthritis, who underwent unilateral TKA in our hospital, were enrolled in this trial. All subjects were randomly assigned into a drain-clamping group (DC group,53knees) and an autotransfusion group (AF group,50knees) by software PEM3.1.2、Inclusion criteria, exclusion criteria and procedureInclusion criteria:The patients with primary knee osteoarthritis, who underwent the first TKA in our institute.Exclusion criteria:(1) patients with coagulation mechanism with obstacle, or long-term use of anticoagulant drugs in the near future can’t stop;(2) malnutrition in patients with severe anemia;(3) complex knee lesions cannot be standards for patients with TKA.(4) TKA for readmission to the hospital after revise of patients.Patients who had severe cerebrovascular disease, blood system diseases and vascular disease were excluded from the study. Hypertensive disease, by taking medications to control blood pressure stable, no medical complications such as diabetes and the blood coagulation disorders (under control the blood pressure140/90mmHg, blood glucose control<8.0mmol/L, have diabetes use reasonable dose of insulin, blood glucose control<8.3mmol/L, control the blood pressure130/80mmHg); Preoperative1weeks did not take aspirin and other drugs affect platelet aggregation and blood coagulation, no obvious abnormal preoperative examination blood coagulation function; Preoperative color doppler check rule out lower extremity DVT. This study was approved by the ethics committee of hospital, and all the patients provided their written informed consent.Patients used antibiotics for half an hour of preoperative. A pneumatic tourniquet with a suitable pressure was inflated after limb exsanguinations and only one time. DC group tourniquet duration was95.58±16.32min, AF group tourniquet duration was96.47±14.49min (t=1.07, P=0.28).All operations were performed under the supervision of the senior surgeon, who is experienced in TKA, performed on patients who were under general anesthesia. The knee joint was exposed through a midline skin incision and a medial parapatellar capsule incision. The tibial and femoral components in all knees were fixed with cement. A same fixed-bearing design (Smith-nephew) was used. The patellas were not replaced.Before closing the wound, a group will be in accordance with the scope of incision and the drainage tube depth pruning operation field length, buried in the joint cavity, external clamping immediately after negative pressure drainage bottle, a set of two drainage catheter end embedded in articular cavity, and the other end with a "Y" type connector is connected to the vacuum pressure suction bottle, after closing the wound, placed vacuum knob in a low, negative pressure value of25mmHg. After incision closed wound and release a tourniquet.3、Postoperative managementAfter wound closure, withoutcompressive Robert Jones bandage. Postoperative blood pressure are controlled under140/90mmHg mmHg, with diabetes blood glucose control<8.3mmol/L, control the blood pressure130/80mmHg, DC group underwent open after6hours, were removed48hours postoperatively. AF group tube connecting ConstaVac TM Ⅱ, recycling within6hours of blood collection, were removed48hours postoperatively.All patients take Rivaroxaban after12hours postopertively,14days after drug withdrawal. Use antibiotics to prevent infection and without the hemostatic,3days after, a walking exercise were initiated and continue CPM lower limb functional exercise, check out X-ray, take Doppler ultrasound screening in order to exclude DVT.4、Observation(1) Volume of drainage postoperation:Observe and record in48h, DC group, volume of drainage is the total drainage of drainage in liquid bottle; For AF group, volume of drainage calculation formula is as follows:volume of drainage=remaining amount in bottle+transfution amount.(2) Blood transfusion amount postoperation:Record allogeneic blood transfusion amount. Hb is less than90g/L or tachycardia, low blood pressure, severe anemia symptoms such as dizziness, or continue to seep incision (excluding hypoal-buminemia due to seepage), is giving infusion1-3unit allogeneic red blood cells.(3) Total blood loss and Hidden blood loss:Monitoring of preoperative and postoperative1day,3day,6day check routine blood dynamic understanding of Hb, Hct, etc. Gross equation after observation records of the results, when calculating the total blood loss and hidden blood loss on the basis of the estimated blood loss. Blood loss calculation formula is as follows:Blood Volume (Patient’s Blood Volume, PBV)=k1×height (m3)+k2*weight (kg)+k3, where k1=0.3669, k2=0.03219, k3=0.6041for men; and k1=0.3561, k2=0.03308, k3=0.1833for women. Hidden blood loss=(preoperatie red blood cells deposited-postoperatie red blood cells deposited) by blood volume; Total blood loss=hidden blood loss+autologous blood amount+allogeneic blood transfusion.(4) Limb swelling:observation and measurement in preoperative and postoperative1day,3day,6day of the thigh and calf circumference, according to the circumference and the difference of measurement value of preoperative limb circumference to judge the degree of swelling increased. The thigh and calf circumference measurement point the patellar10cm and5cm below tibial tubercle.(5) Range of motion of the knee:After3months of observation and measurement of the largest range of motion of the knee.(6) Risk of DVT:After14day surgery or for suspected vascular embolism symptom check color Doppler Ultrasound, exclude DVT. (7) Infection rate:Observed two groups of patients with wound healing, in accordance with the "A","B","C" grade method to determine whether there is any evaluation incision healing of incision infection and grading.Result1. The total drainage of the DC group was161.13±138.63ml, which was significantly reduced637.07±318.40ml than that of the AF group (798.20±337.93ml, P<0.01).2. Two groups in postoperative1day relative preoperative Hb largest decline, DC group felt15.73%±6.45%, AF group felt21.00%±4.47%. Postoperative1day, DC group Hb was101.98±12.54g/L,AF group was99.80±12.29g/L. Be3day and6day,both of twogroups were drop slow, DC group set a cumulative decline of22.57%±9.95%and21.79%±9.23%, AF group were27.77%±6.45%and28.06%±7.00%. Be3day and6dayr Hb in DC group were93.26±12.03g/L and94.02±9.36g/L, AF group were91.04±11.53g/L and90.70±12.05g/L, preoperative Hb and postoperative Hb changes in the two groups were not statistically difference (P>0.05). However, two groups of postoperative Hb compared with preoperative the cumulative decline there is statistical difference between groups (P<0.01).3. Two groups in postoperative1day Hct largest decline, DC group felt15.75%±7.66%, AF group were13.98%±7.65%. Be3day and6day, DC group were26.81%±11.00%and22.42%±12.10%, AF group were25.06%±9.17%and25.72%±10.32%, two groups Hct drop1day,3day and6day after operation had no statistically difference (P>0.05).4. With comparable volume of hidden blood loss (793.54±325.50ml in DC group vs.712.77±338.22ml in AF group, P=0.22), the volume of total blood loss was1024.85±422.68ml in the DC group, which was significantly less than that of the AF group (1561.54±416.83ml).DC group total blood loss significantly reduced536.69±268.23ml than AF group (t=6.48, P<0.01). DC group of hidden blood loss accounts for69.55%of the total blood loss, AF group of hidden blood loss accounts for50.83%of the total blood loss.5. DC group of allogeneic blood transfusion amount is150.94±159.74ml, AF group of allogeneic blood transfusion amount is200.00±169.71ml, two groups of allogeneic blood transfusion volume there was no significant difference (t=1.50, P=0.14). DC group of allogeneic blood transfusion rate was56.00%, AF group of allogeneic blood transfusion rate was65.31%, postoperative drainage of the two groups of allogeneic blood transfusion rate, the lack of statistical difference between groups (χ2=0.90, P=0.34).6. Postoperative thigh circumference AF group respectively increase13.79%±5.21%,15.24%±5.67%,12.86%±5.40%, DC group respectively increase13.16%±4.95%,13.91%±5.30%,12.08%±6.66%. After1day,3day,6day thigh circumference growth lack of significant differences between groups (P values were0.53,0.21and0.51). Postoperative crus circumference AF group respectively increase8.30%±5.21%,9.21%±5.88%,7.61%±4.69%, DC group respectively increase8.51%±3.95%,9.24%±4.26%,8.02%±5.29%. After1day,3day,6day crus circumference growth lack of significant differences between groups (P values were0.83,0.97and0.69).7. Three months after TKA, ROM of the DC group was96.53±6.07°, ROM of the AF group was96.72±6.85°. A lack of statistical differences between groups (t=1.17,P=0.88).8. DC group1case happened DVT at4day postoperative. AF group of DVT was not occurred. Although DC group DVT incidence (1.89%) higher than to AF group (0%), but the lack of statistical difference between groups (x2=0.95, P=0.33).9.2cases of the DC group had Grade "B" wound healing, AF group of patients with all Grade "A" wound healing. Although the wound healing rate of DC group (96.23%) is lower than AF group (100%), but infection rate of lack of statistical differences between groups (χ2=1.92, P=0.17).Conclusions1. Strategy of6hours’drain clamping can effectively reduce postoperative blood loss and drainage than autotransfusion after total knee arthroplasty, but, did not significantly reduce the hidden blood loss, so can not decline the transfusion rate and amount of blood transfusion. 2. Clamping tube6hours method compared with autologous blood transfusion scheme, does not increase the postoperative limb swelling degree, does not impact postoperative range of motion in the near future.3. Although the two kinds of drainage scheme of incision infection rate and the incidence of DVT are lack of statistical differences, but, considering the influence factors such as sample size is small, drainage-clamping tube6hours may increase the potential risk of incision infection rate and the incidence of DVT, that is still worthy of attention.