Arch Orthop Trauma Surg (2015) 135:709–713 DOI 10.1007/s00402-015-2192-z

KNEE ARTHROPLASTY

No need for use of drainage after minimally invasive unicompartmental knee arthroplasty: a prospective randomized, controlled trial Qidong Zhang • Qian Zhang • Wanshou Guo • Zhaohui Liu • Liming Cheng • Guangduo Zhu

Received: 14 September 2014 / Published online: 8 March 2015 Ó Springer-Verlag Berlin Heidelberg 2015

Abstract Objective Drainage is a common procedure in unicompartmental knee arthroplasty (UKA), but evidence regarding its effectiveness is lacking. The aim of this study was to investigate the benefits of drainage after minimally invasive UKA with effective blood loss management. Methods This was a prospective, randomized, controlled trial to determine whether drainage after UKA provides benefits with respect to blood loss, drainage volume, complications, pain score, knee score, range of motion and cost. The 96 patients who underwent surgery between January 2012 and March 2013 were randomly divided into two groups: group A (n = 48) was treated without drainage, and group B (n = 48) with drainage. All UKA procedures were performed with the same minimally invasive surgical technique. Tranexamic acid and bone wax were used for the management of blood loss in all patients. The preoperative baseline parameters of the two groups did not differ significantly. Results The mean drainage volume in group B was 75.7 ± 51.2 mL when the drainage was present. Total blood loss in group A and group B was 240.3 ± 73.3 mL and 274.1 ± 99.5 mL, respectively. These amounts did not differ significantly but both were significantly lower than the data reported for total knee arthroplasty. There was no difference in mean postoperative hemoglobin and hematocrit between groups. Differences in wound infection, Q. Zhang  W. Guo (&)  Z. Liu  L. Cheng  G. Zhu Department of Joint Surgery, China-Japan Friendship Hospital, Yinghua Street, Beijing 100029, People’s Republic of China e-mail: [email protected] Q. Zhang Beijing University of Chinese Medicine, Yinghua Street, Beijing 100029, People’s Republic of China

incidence of deep vein thrombosis, postoperative Hospital for Special Surgery knee score, visual analog score, and range of motion were not statistically significant between groups. Hospitalization costs for UKA were lower in the absence of drainage. Conclusions The use of drainage in unilateral UKA provides no apparent advantage. With effective blood loss management and a minimally invasive procedure, blood loss and drainage volume in UKA are very low. Drainage does not improve the results. Foregoing non-drainage after UKA reduces both hospital costs and visible blood loss. Therefore, drainage is unnecessary in routine UKA. Keywords Unicompartmental knee arthroplasty  Drainage  Blood loss

Introduction As the proportion of older people in the global population increases, the number of knee arthroplasties has increased as well. Among the different types of replacement procedures, unicompartmental knee arthroplasty (UKA) is a relatively less invasive surgical procedure [1, 2]. The mobile Oxford phase 3 implant was introduced in 1998 and has been widely adopted [3–6]. Whether using drainage or not after knee arthroplasty is controversial, especially in total knee arthroplasty (TKA). Advocates of drainage claim that it decreases the risk of articular effusion and hematoma formation, which may inhibit wound healing, increase prosthetic infection rate, and slow down rehabilitation [7]. However, opponents maintain that drainage increases postoperative blood loss and does not improve the surgical result [8]. Several studies have examined the use of drainage in TKA, but they have

123

710

Arch Orthop Trauma Surg (2015) 135:709–713

not involved in UKA [9–12]. Despite, a lack of evidence in the literature supporting the use of drainage in UKA, drainage after UKA is still the standard of management [13–15]. However, with improvements in blood loss management techniques and minimally invasive procedures, blood loss has been greatly reduced [16, 17]. In light of these advances, the use of drainage in UKA needs to be reconsidered. We, therefore, conducted a prospective randomized, controlled trial to determine the effects of drainage performed after UKA on blood loss, drainage volume, complications, pain score, knee score, range of motion (ROM), and cost. The hypotheses of the study were that: (1) blood loss and drainage volume in UKA are already very low because of effective blood loss management and minimally invasive procedures, thus obviating the need for drainage and (2) foregoing non-drainage after UKA reduces cost but has no adverse effect on the results of UKA.

Materials and methods From January 2012 to March 2013, patients with a primary diagnosis of osteoarthritis who underwent primary minimally invasive UKA were prospectively studied. Patients with simultaneous bilateral operations, previous major bleeding, a history of knee surgery, and revision were excluded from the study. Approval of the study was obtained from the Institutional Review Board of our hospital. All patients signed informed consent forms before UKA. The 96 patients who participated in the study were randomly divided into two groups using computer-generated numbers: patients in group A (n = 48) were treated without drainage, whereas those in group B (n = 48) were treated with drainage. The effects of drainage on UKA

were examined with respect to blood loss, postoperative drainage volume, knee effusion, wound problems, complications, rehabilitation, pain score, knee score, ROM, and cost. Preoperative information obtained for each patient included weight, height, Hospital for Special Surgery (HSS) knee score, visual analog score(VAS), hemoglobin (Hb), hematocrit (Hct), midpatellar knee circumference, and ROM (Table 1). The mobile Oxford medial UKA (Oxford unicompartmental knee, Biomet, Bridgend, UK) was used in all patients. All UKA procedures were performed by the senior author using the same minimally invasive surgical technique and blood loss management. The knee joint was exposed through a small skin incision with quadriceps sparing and no patellar eversion. All ligaments were kept intact without release. A tourniquet was used and deflated at the end of prosthesis fixation. Tranexamic acid (1000 mg) was administered intravenously 10 min before deflation of the tourniquet. Bone wax was topically used to close the uncovered osteotomy surfaces and nail holes after implantation of the prosthesis. In group B patients, a drainage tube with an external diameter of 3.2 mm (B Braun Ltd, Melsungen, Germany) was inserted into the articular cavity at the end of the surgical procedure. The closed-suction drain was left open and removed 24 h later. The drainage volume was measured in a 500-mL measuring cylinder. After the operation, the compression dressings were left on the lower limbs of patients in both groups for 24 h. After removal of the blood-saturated dressings, they were weighed for blood loss determination. Patients were encouraged to start early weight-bearing and quadriceps exercises. All patients were administered rivaroxaban (5 mg), as antithrombotic prophylaxis, 24 h after surgery and during the next 14 postoperative days. Antibiotic prophylaxis consisted of ceftriaxone (2.25 g) injected

Table 1 Demographic data for study participants Group A (non-drainage)

Group B (drainage)

Number (knees)

48

48

Age (years)

67.6 ± 10.1

66.5 ± 10.2

Side (left:right)

25/23

23/25

Sex (male:female)

10/38

14/34

BMI (kg/m2)

25.1 ± 3.3

25.5 ± 3.0

t/v2

P value

-0.544

0.588

0.167

0.683

0.889

0.346

-0.615

0.540

Preoperative Hb level (g/L)

133.3 ± 11.9

134.7 ± 12. 4

0.547

0.586

Preoperative Hct (%)

39.5 ± 4.1

39.9 ± 4.1

0.472

0.638

Preoperative knee circumference (cm) Preoperative HSS score

43.3 ± 3.2 58.9 ± 7.5

42.9 ± 2.3 58.8 ± 8.9

0.658 -0.025

0.512 0.980 0.205

Preoperative VAS score

6.7 ± 1.1

6.9 ± 1.0

1.277

Preoperative range of motion (°)

124.6 ± 8.2

123.90 ± 9.8

0.401

0.689

Mean follow-up (months)

18.3 ± 5.3

18.3 ± 3.8

-0.088

0.930

123

Arch Orthop Trauma Surg (2015) 135:709–713

30 min before surgery and once more during the 24 h after surgery. Blood loss was evaluated as total blood loss and visible blood loss, which were measured on the third day after surgery. Visible blood loss was assessed by measuring the blood loss at operation, increase in the weight of the dressings and the volume of the blood drained when drainage was present. Gross’s [18] formula was used to calculate total blood loss with respect to the patients’ weight, height, and hematocrit. Homologous blood transfusion was performed in patients with hemoglobin level \70 g/L and in those who presented with symptoms of anemia [19]. Both groups were monitored for transfusion, postoperative ecchymosis, wound healing, deep vein thrombosis (DVT), and other complications. The circumference of the knee at the midpatellar point was measured on postoperative days 1, 3, and 5 to monitor articular effusion. The HSS score, VAS score, and ROM were also determined 1 year after UKA. All data were analyzed using SPSS version 17.0 (SPSS, Chicago, IL, USA). The data are reported as the mean ± standard deviation. The v2 test and Student’s t test were used to determine statistically significant differences between the groups. A P \ 0.05 was considered statistically significant [20].

Results The mean age of the 96 patients who participated in the study was 67.0 ± 10.1 years (range 46–85 years). The average body mass index (BMI) and preoperative hemoglobin were 25.3 ± 3.1 kg/m2 (range 19.5–31.6 kg/m2) and 134.0 ± 12.1 g/L (range 108–180 g/L), respectively. The mean operative time was 57.1 ± 10.0 min (range 40–88 min). The two groups were comparable in terms of age, surgical side, sex distribution, operative time, BMI, follow-up (Table 1).There were also no differences in the mean preoperative hemoglobin concentration (group A: 133.3 ± 11.9 g/ L, group B: 134.7 ± 12.4 g/L; P = 0.586) and hematocrit (group A: 39.5 ± 4.1 %, group B: 39.9 ± 4.1 %; P = 0.638). After UKA, the two groups did not significantly differ with respect to either the mean postoperative hemoglobin concentration (125.0 ± 11.3 g/L in group A, 124.4 ± 12.3 g/L in group B; P = 0.809) or the mean postoperative hematocrit (group A 35.0 ± 3.3 %, group B 34.2 ± 3.5 %; P = 0.248). The mean blood loss for all 96 UKAs was 257.2 ± 88.6 mL. In group A patients, total blood loss and visible blood loss were 240.3 ± 73.3 and 103.5 ± 37.7 mL, respectively. In group B patients, the corresponding values were 274.1 ± 99.5 and 168.4 ± 59.2 mL. Total blood loss did not differ statistically between the two groups (P = 0.061),

711

whereas visible blood loss was significantly lower in group A (P = 0.000). None of the patients required transfusion, as blood loss was small and all patients had a hemoglobin level above 70 g/L. The mean drainage volume was 75.7 ± 51.2 mL (5–250 mL) when the drainage was present. Early motion and weight-bearing were achieved in all patients during the hospitalization period. Patients in group A had a mean hospitalization of 6.3 ± 1.4 days and those in group B, a mean hospitalization of 6.7 ± 1.5 days (P = 0.621). Analysis of knee circumference on postoperative days 1, 3, and 5 showed no significant differences in midpatellar knee circumference between the two groups. ROM, measured 1 year after UKA, was 128.1 ± 6.1° in group A and 127.5 ± 6.6° in group B (P = 0.625). The two groups also did not differ significantly with respect to postoperative HSS score and VAS score (P = 0.421 and P = 0.751, respectively; Table 2). Two patients in each group developed wound ecchymosis during their hospital stay. Because of an allergic reaction to the dressings, one patient in group A developed wound blisters, which resolved after removal of the dressing. During the follow-up period, none of the patients developed deep infections or DVT. The incidence of complications did not differ significantly between group A and group B patients. The cost of UKA with non-drainage was lower than that with drainage. The average total hospitalization bill for UKA in group A patients was CNY(Chinese Yuan) 40,705.37 ± 998.85 vs. CNY42,386.69 ± 2086.97 in group B patients (P \ 0.05). The cost reduction of CNY1681.31 was due to the absence of the drainage tube and related costs (Table 2).

Discussion The most important findings of this study were the small amounts of blood loss and, in patients treated with drainage, the low drainage volume, both of which can be attributed to effective blood loss management and the minimally invasive procedure used in UKA. Our results showed that non-drainage did not increase the risk of articular effusion, hematoma formation, or prosthetic infection and did not delay rehabilitation. Analysis of knee circumference on postoperative days 1, 3, and 5 showed no significant differences between the two groups, which demonstrated that non-drainage did not cause articular effusion. At the 1-year follow-up examination, the two groups of patients did not differ significantly in postoperative HSS score, pain score, and ROM. Therefore, drainage did not confer any obvious advantages in patients undergoing unilateral UKA.

123

712

Arch Orthop Trauma Surg (2015) 135:709–713

Table 2 Comparison after drain and non-drainage

Group A (non-drainage)

Group B (drainage)

t value

P value

Number (knees)

48

48

Duration of surgery (minuets)

56.6 ± 9.4

57.6 ± 10.7

0.497

0.621

Hospital stay (days)

6.3 ± 1.4

6.7 ± 1.5

1.205

0.231

Cost (¥)

40,705.37 ± 998.85

42,386.69 ± 2086.97

Postoperative Hb level (g/L)

125.0 ± 11.3

124.4 ± 12.3

-5.035

0.000

0.242

0.809

Postoperative Hct (%)

35.0 ± 3.3

34. 2 ± 3.5

1.162

0.248

Total blood loss (ml)

240.3 ± 73.3

274.1 ± 99.5

1.895

0.061

Visible blood loss (ml)

103.5 ± 37.7

168.4 ± 59.2

6.427

0.000

44.8 ± 2.5

0.341

0.734

Postoperative knee circumference (cm) Postoperative 1 day Postoperative 3 day

45.7 ± 3.1

44.9 ± 2.7

1.305

0.195

Postoperative 5 day

45. 7 ± 3.2

45.1 ± 2.8

0.958

0.341

Postoperative HSS score

92.2 ± 4.3

93.0 ± 5.0

0.808

0.421

Postoperative VAS score

2.1 ± 1.0

2.0 ± 0.9

0.319

0.751

Postoperative range of motion (°)

128.1 ± 6.1

127.5 ± 6.7

-0.490

0.625

However, foregoing non-drainage after UKA reduced not only the cost of the procedure but also the visible blood loss. Blood loss management techniques in knee arthroplasty have developed rapidly and have greatly improved the procedure. In fact, blood loss management has become a routine adjunctive treatment in arthroplasty. Tranexamic acid, administered as an intravenous infusion in knee arthroplasty, was shown to significantly reduce intraoperative blood loss, by [50 %, in patients undergoing TKA [21–24]. The application of bone wax to bleeding cancellous bone surfaces is another safe and effective method to reduce blood loss, as the wax provides both a physical barrier and a tamponade effect to stop bleeding [25]. The use of these blood management procedures in our patients minimized blood loss, as evidenced by the mean blood loss of only 257.2 ± 88.6 mL. None of the patients in our study suffered a reduction of hemoglobin levels to \90 g/L, and none required transfusion. Because our study lacked a TKA control group, we compared the total blood loss of our UKA patients with the least volume reported for TKA in the literature, which ranged from 535 to 1768 mL [8, 26, 27]. The smallest volume for TKA in the literature (535 ± 295 ml) was reported by Li et al., which was significantly more than the total blood loss of UKA in our study (P \ 0.05). Although the inclusion of a TKA control group may have strengthened the findings of our clinical trial, our results of minimal blood loss are consistent with those in the literature. In 2003, Yang compared minimally invasive UKA with TKA in a matched-pair study and found less blood loss and higher postoperative hemoglobin in UKA than in TKA patients [28]. Similarly, Schwab et al. [29] reported a decrease in hemoglobin after UKA of only 10 g/L, which was significantly lower than that after TKA.

123

45.0 ± 3.2

Drainage has been discussed controversially in TKA but has received little attention in UKA, especially since the advent of minimally invasive procedures and effective blood loss management [30]. In 2004, Confalonieri et al. conducted a trial in which patients underwent UKA with implantation of the UC-Plus Solution prosthesis. This Italian study compared the use of a postoperative drain with non-drainage but found no difference in outcomes [31]. Despite limited numbers (78 knees), this was the only available series in the literature. As surgical techniques and instruments have improved, especially, combining with the use of multimodal blood management, the drainage application has become valueless. Our results show that with these improvements in UKA and the use of multimodal blood management, there are no benefits to be gained from using drainage. However, drainage increased both the cost of hospitalization and visible blood loss in fact. Our study had several limitations. First, our analysis was confined to early postoperative results and complications; thus, our clinical findings will need to be confirmed in longer trials. Second, the number of patients in the trial was relatively small. A randomized controlled study adequately powered with a larger number of patients will be needed to validate our results. Third, both the total blood loss and the drainage volume were very low in our UKA patients; whether the same results would be obtained without multimodal blood management to control blood loss remains to be determined. Nonetheless, at least in this study, the use of drainage in unilateral UKA did not improve the clinical results. With effective blood loss management and the use of a minimally invasive procedure, blood loss and drainage volume were both very low. Moreover, by omitting drainage after UKA, hospitalization costs were reduced, as was

Arch Orthop Trauma Surg (2015) 135:709–713

visible blood loss. In conclusion, the use of drainage in routine UKA cannot be recommended. Conflict of interest

No conflicts of interest exist in this study.

References 1. Berend KR, Lombardi AJ (2008) Mobile-bearing unicompartmental knee arthroplasty (UKA). Orthopedics 31(5 Suppl):S6–S8 2. Berger RA, Della VC (2010) Unicompartmental knee arthroplasty: indications, techniques, and results. Instr Course Lect 59:47–56 3. Kort NP, van Raay JJ, van Horn JJ (2007) The Oxford phase III unicompartmental knee replacement in patients less than 60 years of age. Knee Surg Sports Traumatol Arthrosc 15(4):356–360 4. Pandit H, Jenkins C, Barker K et al (2006) The Oxford medial unicompartmental knee replacement using a minimally-invasive approach. J Bone Joint Surg Br 88(1):54–60 5. Tang H, Zhao L, Yan H et al (2012) Mid-term effectiveness of Oxford Unicompartmental Knee System Phase III for medial unicompartmental knee osteoarthritis. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi 26(1):17–20 6. Zhang Q, Zhang Q, Guo W et al (2014) The learning curve for minimally invasive Oxford phase 3 unicompartmental knee arthroplasty: cumulative summation test for learning curve (LCCUSUM). J Orthop Surg Res. 9(1):81 7. Reilly TJ, Gradisar IJ, Pakan W et al (1986) The use of postoperative suction drainage in total knee arthroplasty. Clin Orthop Relat Res 208:238–242 8. Li C, Nijat A, Askar M (2011) No clear advantage to use of wound drains after unilateral total knee arthroplasty: a prospective randomized, controlled trial. J Arthroplasty 26(4):519–522 9. Zhang QD, Guo WS, Zhang Q et al (2011) Comparison between closed suction drainage and nondrainage in total knee arthroplasty: a meta-analysis. J Arthroplasty 26(8):1265–1272 10. Jenny JY, Boeri C, Lafare S (2001) No drainage does not increase complication risk after total knee prosthesis implantation: a prospective, comparative, randomized study. Knee Surg Sports Traumatol Arthrosc 9(5):299–301 11. Kim YH, Cho SH, Kim RS (1998) Drainage versus nondrainage in simultaneous bilateral total knee arthroplasties. Clin Orthop Relat Res 347:188–193 12. Fan Y, Liu Y, Lin J et al (2013) Drainage does not promote postoperative rehabilitation after bilateral total knee arthroplasties compared with nondrainage. Chin Med Sci J 28(4):206–210 13. Goodfellow JW, O’Connor JJ, Dodd C et al (2006) Unicompartmental arthroplasty with the Oxford knee 14. Sun PF, Jia YH (2012) Mobile bearing UKA compared to fixed bearing TKA: a randomized prospective study. Knee 19(2):103–106

713 15. Ares O, Seijas R, Hernandez A et al (2013) Knee arthroplasty and bleeding: when to remove drainages. Knee Surg Sports Traumatol Arthrosc 21(2):393–397 16. Zhang H, Chen J, Chen F et al (2012) The effect of tranexamic acid on blood loss and use of blood products in total knee arthroplasty: a metaanalysis. Knee Surg Sports Traumatol Arthrosc 20(9):1742–1752 17. Ishida K, Tsumura N, Kitagawa A et al (2011) Intra-articular injection of tranexamic acid reduces not only blood loss but also knee joint swelling after total knee arthroplasty. Int Orthop 35(11):1639–1645 18. Gross JB (1983) Estimating allowable blood loss: corrected for dilution. Anesthesiology 58(3):277–280 19. Yuke T, Yun Y, Shanglong Y et al (2009) Practice guidelines for perioperative blood transfusion: Chinese Society of Anaesthesiology. J Clin Anesthesiol 25(3):189–191 20. Nayak BK, Hazra A (2011) How to choose the right statistical test? Indian J Ophthalmol 59(2):85–86 21. Tan J, Chen H, Liu Q et al (2013) A meta-analysis of the effectiveness and safety of using tranexamic acid in primary unilateral total knee arthroplasty. J Surg Res 184(2):880–887 22. Wind TC, Barfield WR, Moskal JT (2013) The effect of tranexamic acid on blood loss and transfusion rate in primary total knee arthroplasty. J Arthroplast 28(7):1080–1083 23. Sabatini L, Atzori F, Revello S et al (2014) Intravenous use of tranexamic acid reduces postoperative blood loss in total knee arthroplasty. Arch Orthop Trauma Surg 134(11):1609–1614 24. Chen JY, Rikhraj IS, Zhou Z et al (2014) Can tranexamic acid and hydrogen peroxide reduce blood loss in cemented total knee arthroplasty? Arch Orthop Trauma Surg 134(7):997–1002 25. Copuroglu C, Ercan S, Ozcan M et al (2011) Comparison of autogenous bone graft donor site haemostatic agents used in spinal surgery. Acta Orthop Traumatol Turc 45(5):359–364 26. Levy O, Martinowitz U, Oran A et al (1999) The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study. J Bone Joint Surg Am 81(11):1580–1588 27. Wong J, Abrishami A, El BH et al (2010) Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am 92(15):2503–2513 28. Yang KY, Wang MC, Yeo SJ et al (2003) Minimally invasive unicondylar versus total condylar knee arthroplasty—early results of a matched-pair comparison. Singap Med J 44(11):559–562 29. Schwab P E, Lavand’Homme P, Yombi J C et al (2014)Lower blood loss after unicompartmental than total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 30. Heyse TJ, Efe T, Rumpf S et al (2011) Minimally invasive versus conventional unicompartmental knee arthroplasty. Arch Orthop Trauma Surg 131(9):1287–1290 31. Confalonieri N, Manzotti A, Pullen C (2004) Is closed-suction drain necessary in unicompartmental knee replacement? A prospective randomised study. Knee 11(5):399–402

123

No need for use of drainage after minimally invasive unicompartmental knee arthroplasty: a prospective randomized, controlled trial.

Drainage is a common procedure in unicompartmental knee arthroplasty (UKA), but evidence regarding its effectiveness is lacking. The aim of this study...
342KB Sizes 0 Downloads 7 Views