Eur J Orthop Surg Traumatol (2014) 24:999–1003 DOI 10.1007/s00590-013-1351-6
ORIGINAL ARTICLE
Tourniquet used in anterior cruciate ligament reconstruction: a system review Hong Wu • Ling-Xiao Chen • Yu-Lin Li • Qiang Wu • Qiu-Li Wu • Guang-Zhi Ning Shi-Qing Feng
•
Received: 21 July 2013 / Accepted: 30 October 2013 / Published online: 13 November 2013 Ó Springer-Verlag France 2013
Abstract Purpose To identify whether routine use of a tourniquet is a better choice for anterior cruciate ligament reconstruction. Method We searched Amed, British Nursing Index, Embase, Pubmed, Scopus, Cochrane Library and Google Scholar. We used revised Jadad score to evaluate the trial quality. Each reference list was viewed for any ignored studies. Two reviews independently extracted data from all eligible trials, including study design, patients’ characteristics, interventions and outcomes. The available data were using random effects models with mean differences for continuous variables. Results The only meta-analysis indicated there was no significant difference in operative time between the tourniquet and non-tourniquet groups (mean differences -5.71, 95 % CI -12.40, 0.99). The remaining outcomes had variations in the outcome measures, so it was not possible to perform meta-analysis. Conclusions There was insufficient evidence to support the hypothesis that patients would benefit from routinely applying a tourniquet. More high-quality randomized controlled trials were needed to test the result. Keywords Tourniquet Anterior cruciate ligament reconstruction System review RCTs Hong Wu and Ling-Xiao Chen have equally contributed to this research. H. Wu L.-X. Chen Y.-L. Li Q. Wu Q.-L. Wu G.-Z. Ning S.-Q. Feng (&) Department of Orthopaedics, Tianjin Medical University, General Hospital, 154 Anshan Road, Heping District, Tianjin 300052, People’s Republic of China e-mail: [email protected]
Introduction Anterior cruciate ligament (ACL) injury was always happened in athletes, especially in competition rather than in practice [1]. In athletes, the incidence of anterior cruciate ligament rupture was three times higher in female than in male [2]. One research pointed out, among United States high school athletes, anterior cruciate ligament injury was ranking third among all involved structures in knee injuries (2.98/10,000 athlete exposures) [1]. There were two ways to treat anterior cruciate ligament injury, one was surgical reconstruction, and the other was non-surgical management. Although some studies showed a considerable percentage of patients with ACL injury continue to participate in furious sports, the majority of studies indicated poor functional outcomes in patients treated non-operatively [3– 5]. The use of tourniquet was first proposed in 1904 and is now a routine procedure in surgery [6]. The effects of tourniquet were the attribute to its ability to improved the surgical field visibility and increased the accuracy of the procedure and reduced surgical time [7]. It had been used in different patient groups, including patients undergoing total knee arthroplasty and patients undergoing foot and ankle surgery [8–11]. The use of tourniquet had been demonstrated to significantly reduce intra-operative blood loss and enhanced thromboembolic complication in total knee arthroplasty and to significantly shorten the hospital length of stay during foot and ankle surgery [8–11]. Anterior cruciate ligament reconstruction is currently performed either with or without a tourniquet depending on the surgeon’s experience [6]. Recently, there were published randomized controlled trials (RCTs) regarding the use of tourniquet in anterior cruciate ligament reconstruction. However, these studies had a small sample size and
123
1000
conveyed uncertain results. So we undertook a system review of published RCTs conducted in anterior cruciate ligament reconstruction to determine whether the use of tourniquet compared with a control benefited the patient.
Methods Data sources We searched Amed (from 1985 to June 2013), British Nursing Index (from 1985 to June 2013), Embase (from 1974 to June 2013) and Pubmed (from 1966 to June 2013). We also searched Scopus, Cochrane Library and Google Scholar. Unpublished literature was also assessed with the search terms ‘‘tourniquet’’ and ‘‘anterior cruciate ligament reconstruction’’ from SIGLE (System for Information on Grey Literature in Europe), the National Technical Information Service, the National Research Register (UK) and the Current Controlled Trials databases. We viewed each reference list for any ignored studies.
Eur J Orthop Surg Traumatol (2014) 24:999–1003
Quality assessment The methodological quality of each trial was evaluated using the revised Jadad scale. The scale consists of 4 items: producing randomization (0–2 points), allocation concealment (0–2 points), blinding (0–2 points) and describing of dropouts and withdrawals (0–1 points) in the report of an RCT. The total score was 7 points; 0–3 points mean poor quality, and 4–7 points mean high quality. Statistical analyses We conducted all statistical analysis using Review Manager 5.2. When we found no evidence of a substantial difference in study populations, interventions and outcome measurements, we performed a meta-analysis. Heterogeneity across studies was tested by using the I2 statistic and a chi-square test. If the data were not homogeneous, metaanalysis was not performed.
Results Inclusion and exclusion criteria Study identification and selection Studies were considered acceptable for inclusion in the system review if they met the criteria: (1) Anterior cruciate ligament reconstruction; (2) RCTs; (3) Tourniquet compared with non-tourniquet group. Trials were excluded if they: (1) were abstracts, letters, or meeting proceedings; (2) had repeated data or did not report outcomes of interest. Study identification All titles and abstracts identified from the search strategy were independently screened by two authors. The full texts for all potentially eligible studies were selected. These were then reviewed by each of the two independent reviewers again to avoid some mistakes occurring.
An initial database search identified a total of 35 RCTs. 17 RCTs were excluded because of duplicate studies, and 13 RCTs were excluded based on the titles and abstracts. The remaining 5 full-text articles were reviewed for more detailed evaluation, 1 of them was also excluded because it was a letter to the editor [12]. Finally, 4 RCTs that met our inclusion criteria were included in the present system review [7, 13–15]. The flowchart of studies included in the system review is shown in Fig. 1.
Articles identified by database and hand research N=35
Excluded(duplicate studies) N=17
Data extraction and outcome measures Titles and Abstracts screened N=18
Two reviewers (Wu and Chen) independently extracted the following data: first author, year of publication, number of patients, patients’ characteristics, use of tourniquet (pressure, time) and outcomes (operation time, blood loss through the intra-articular drain, total blood loss, thigh girth, calf girth, pain score, numbness score, kinetic quadriceps and hamstring strength). Any disagreement was resolved by discussion. If there were still some debates, they consulted further reviewer and expert (Feng) to decide.
123
Excluded: N=13 -Not RCTs: N=5 -No tourniquet vs non-tourniquet: N=8 Full-text articles assessed for eligibility N=5 Full-text articles excluded N=1 Letter to the editor N=1 Articles included N=4
Fig. 1 Flowchart of studies included in system review
Eur J Orthop Surg Traumatol (2014) 24:999–1003
1001
Table 1 Main characteristics References
Sample sizes (T/NT)
Gender (male/female)
Mean age (range), years
Tourniquet parameters
T
NT
T
NT
Pressure (mmHg)
Time (min)
Revised Jadad score
Outcome measures
Hiroshi [7]
51 (28/ 23)
11/17
16/7
24.8 (14–45)
26.7 (15–45)
300
NA
1
Operative time; pain score; numbness score; thigh girth; total blood loss; blood loss through the drain; function testing
Nicholas [14]
48 (25/ 23)
13/12
16/7
33 ± 7
32 ± 9
300
85 ± 7
3
Thigh girth; calf girth; dorsiflexion strength; plantarflexion strength
Hooper [13]
29 (14/ 15)
5/9
10/9
35.3 ± 7.8
35.7 ± 6.6
300
NA
6
Operative time; postoperative morphine; consumption; postoperative pain scores; arthroscopic visibility
Arciero [15]
40 (20/ 20)
13/7
17/3
26 (18–41)
22 (18–34)
269
87
2
Operative time; serum CPK values; thigh and calf girth; isokinetic testing; functional testing
Other outcomes
Table 2 Outcome data References
Hiroshi [7]
Operative time, min
Hiroshi 2013
Tourniquet
Non-tourniquet
115 ± 18
122 ± 17
Nicholas [14]
NA
NA
Hooper [13]
60.8 ± 9.6
65.3 ± 15.5
Arciero [15]
128
137
Characteristics of the studies The main characteristics of the 4 RCTs included in the system review are presented in Table 1, and the outcome data of each included trial are described in Table 2. These studies were published between 1996 and 2013. The size of the RCT ranged from 29 to 51 (total 168). Among the 4 studies included here, 2 reported enough data about operative time [7, 13]. The quality of the included studies was assessed by the revised Jadad score. The median revised Jadad score of the studies included was 3 (range 1–6). Outcome: operative time 3 RCTs reported operative time in study patients [7, 13, 15], but 1 RCT did not supply the SD (Stand Deviation) or the original data so we cannot integrate it [15]. No one defined the operative time. The aggregated results of these studies suggest that there was no significant difference between the tourniquet and the non-tourniquet groups (Fig. 2), and no significant heterogeneity among the studies.
The main outcome measures were blood loss through the intra-articular drain, total blood loss, thigh girth, pain score, numbness score, kinetic quadriceps and hamstring strength. The average blood loss from the suction drain through the suprapatellar pouch was 133.6 ± 62.4 ml (range 60–250 ml) in the tourniquet group and 85.3 ± 47.3 ml (range 20–190 ml) in the non-tourniquet group (P = 0.02). The numbness score which was assessed using a zero to five visual analogue score was significantly elevated in the tourniquet group (P = 0.0002). There were no significant differences in terms of total blood loss, thigh girth, pain score and kinetic quadriceps and hamstring strength. There were no details about the blinding of outcome assessment. Nicholas 2001 The main outcome measures were dorsiflexion strength, plantarflexion strength, calf girth, thigh girth, tourniquet time and strength. The decrease in thigh girth after surgery was greater when the tourniquet was used (2.5 cm, range 1.3–3.7 cm), compared to not using the tourniquet (1.1 cm, range 0.4–1.8 cm; P \ 0.05). There were no significant differences in terms of dorsiflexion strength, plantarflexion strength, calf girth, tourniquet time and strength. There were no reports of neuropathies or complications. 2 patients in each group were not tested because of anterior knee pain.
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1002
Eur J Orthop Surg Traumatol (2014) 24:999–1003
Fig. 2 Synthesized analysis of operative time, showing no significant difference between tourniquet and non-tourniquet groups, and no significant heterogeneity among the studies
The paper mentioned that the examiners were blinded; however, no details were provided how the blind was made. Hooper 1999 The main outcome measures were postoperative morphine consumption, postoperation pain score, arthroscopic visibility and satisfaction with pain management. The arthroscopic visibility which was assessed by the surgeon was significantly impaired in the non-tourniquet group compared to the tourniquet group (P \ 0.0001). There were no significant differences in terms of postoperative morphine consumption, postoperative pain scores and satisfaction with pain management. For the sake of the absence of femoral nerve block, one patient was lost to analyze. Arciero 1996 The main outcome measures were creatinine phosphokinase (CPK) determination, electromyography, thigh girth, calf girth, KT-1000 arthromeric testing, isokinetic testing of quadriceps and hamstring muscles, single-legged hop test for time, single-legged hop test for distance and the Lysholm knee score. There were no significant differences in terms of all the above parameters. There was no detail about blinding of outcome assessment. One patient was lost to analyze because he refused to take part in the study 2 weeks after surgery. Three of the trails mentioned thigh girth as an outcome measure. Hiroshi et al. [7] did not provide data, but provided a figure which indicated there was no significant difference between two groups. Nicholas et al. and Arciero et al. provided the mean value and the range, but lack of the SD or the original data, in addition, the examined time was different from each other [14, 15]. Two studies used pain score as an outcome measure. However, there were variations in how it was measured and these studies did not supply adequate data to be analyzed [7, 13]. Two of the trials reported calf girth. Nicholas et al. and Arciero et al. provided the mean value and the range with different measured time [14, 15]. Two of the trials examined the strength of quadriceps and hamstring muscles. Hiroshi et al. did not provide data.
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Arciero et al. provided the mean value and the range, but lack of the SD. The two trials had different measured time [7, 15]. None of the trials reported the cost-effectiveness of the use of a tourniquet in anterior cruciate ligament reconstruction. Publication bias Publication bias was not assessed because the number of studies was small (\10).
Discussion The present study showed the surgeons would not achieve shorter operative time by the application of tourniquet. This outcome, however, was assessed in only two studies with small sample size so the lack of a statistical difference might cause by the type 2 statistical error. One trial told us the amount of blood loss through the intra-articular drain was increased in the tourniquet group; however, the amount of total blood loss was no difference between two groups [7]. Because total blood loss was measured based on the postoperation reduction in hemoglobin value, there was a possibility this indirectly measurement could not identify the difference between two groups precisely. There was a need for a large randomized controlled trial with directly measurement to ascertain the effect of the use of tourniquet on total blood loss. No trials reported the occurrence of complications; however, the small size of the trails made us not determine the incidence of potential scarce complications. We recommended more large-scale RCTs to be undertaken so we might find the significant number of rare complications caused by using a tourniquet in anterior cruciate ligament reconstruction. None of the trials mentioned the cost-effectiveness. The operation time which had an important influence on overall costs was not increased in the tourniquet group. In addition, no information was provided about other equipment or training which made the surgery team adjust to the using of tourniquet [16]. There were some strengths in this paper: (1) it is the first system review to explore the role of tourniquet in anterior cruciate ligament reconstruction; (2) all included trails were assessed by revised Jadad score; (3) we used
Eur J Orthop Surg Traumatol (2014) 24:999–1003
comprehensive search strategy although the number of RCTs is limited. This review had several potential limitations that should be taken into account. First, our analysis was based on 4 RCTs, in addition, only two supported enough data to be analyzed, and the sample size was small. Second, only Hooper et al. [13] concealed patient allocation, allocation bias might have influenced results because the patient’s clinical manifestation might have affected the surgeon’s choice of methods before randomisation. Third, Hiroshi et al. and Arciero et al. did not mention the blinding which means both patients and surgeons might have been influenced by each others’ judgement [7, 15]. Finally, all trails had poor methodological quality and design’s deficient except the trail by Hooper et al. [7, 13–15].
Conclusion The limited evidence suggests that the use of tourniquet in anterior cruciate ligament reconstruction may not reduce the operative time. For exploring the efficacy of tourniquet perfectly, well-designed and large RCTs which include the economic evaluation about costing are needed, to ascertain whether the operation time could be reduced, cost-effectiveness of using the tourniquet and the incidence of the rare complications. Conflict of interest of interest.
The authors declare that they have no conflict
References 1. Swenson DM, Collins CL, Best TM, Flanigan DC, Fields SK, Comstock RD (2013) Epidemiology of knee injuries among US high school athletes 2005/2006–2010/2011. Med Sci Sports Exerc 45(3):462–469 2. Sutton KM, Bullock JM (2013) Anterior cruciate ligament rupture: differences between males and females. J Am Acad Orthop Surg 21(1):41–50 3. Clancy WG Jr, Ray JM, Zoltan DJ (1988) Acute tears of the anterior cruciate ligament surgical versus conservative treatment. J Bone Joint Surg Am 70:1483–1488
1003 4. Engebretsen L, Tegnander A (1990) Short-term results of the non operated isolated anterior cruciate ligament tear. J Orthop Trauma 4:406–410 5. Engstrom B, Gornitzka J, Johansson C, Wredmark T (1993) Knee function after anterior cruciate ligament ruptures treated conservatively. Int Orthop 17:208–213 6. Zhang Y, Li L, Wang J, Li ZH, Shi ZJ (2013) Do patients benefit from tourniquet in arthroscopic surgeries of the knee? Knee Surg Sports Traumatol Arthrosc 21(5):1125–1130 7. Nakayama H, Yoshiya S (2013) The effect of tourniquet use on operative performance and early postoperative results of anatomic double-bundle anterior cruciate ligament reconstruction. J Orthop Sci 18(4):586–591 8. Alcelik I, Pollock RD, Sukeik M, Bettany-Saltikov J, Armstrong PM, Fismer P (2012) A comparison of outcomes with and without a tourniquet in total knee arthroplasty: a systematic review and meta-analysis of randomized controlled trials. J Arthroplast 27(3):331–340 9. He T, Cao L, Yang DS, DL A, Xu BY, Li GQ, Chen H, Zeng Y (2011) A meta-analysis for the efficacy and safety of tourniquet in total knee arthroplasty. Zhonghua Wai Ke Za Zhi 49(6):551–557 10. Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY (2011) Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc 19(7):1121–1130 11. Smith TO, Hing CB (2010) The efficacy of the tourniquet in foot and ankle surgery? A systematic review and meta-analysis. Foot Ankle Surg 16(1):3–8 12. Bollen S (1997) The effect of tourniquet use in anterior cruciate ligament reconstruction—a prospective randomised study. Am J Sports Med 25(2):275–276 13. Hooper J, Rosaeg OP, Krepski B, Johnson DH (1999) Tourniquet inflation during arthroscopic knee ligament surgery does not increase postoperative pain. Can J Anaesth 46(10):925–929 14. Nicholas SJ, Tyler TF, McHugh MP, Gleim GW (2001) The effect on leg strength of tourniquet use during anterior cruciate ligament reconstruction: a prospective randomized study. Arthroscopy 17(6):603–607 15. Arciero RA, Scoville CR, Hayda RA, Snyder RJ (1996) The effect of tourniquet use in anterior cruciate ligament reconstruction. A prospective, randomized study. Am J Sports Med 24(6):758–764 16. Rigby KA, Palfreyman SJ, Beverley C, Michaels JA (2013) Surgery for varicose veins: use of tourniquet. Cochrane Database Syst Rev 6:CD001486
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ORIGINAL ARTICLE
Tourniquet used in anterior cruciate ligament reconstruction: a system review Hong Wu • Ling-Xiao Chen • Yu-Lin Li • Qiang Wu • Qiu-Li Wu • Guang-Zhi Ning Shi-Qing Feng
•
Received: 21 July 2013 / Accepted: 30 October 2013 / Published online: 13 November 2013 Ó Springer-Verlag France 2013
Abstract Purpose To identify whether routine use of a tourniquet is a better choice for anterior cruciate ligament reconstruction. Method We searched Amed, British Nursing Index, Embase, Pubmed, Scopus, Cochrane Library and Google Scholar. We used revised Jadad score to evaluate the trial quality. Each reference list was viewed for any ignored studies. Two reviews independently extracted data from all eligible trials, including study design, patients’ characteristics, interventions and outcomes. The available data were using random effects models with mean differences for continuous variables. Results The only meta-analysis indicated there was no significant difference in operative time between the tourniquet and non-tourniquet groups (mean differences -5.71, 95 % CI -12.40, 0.99). The remaining outcomes had variations in the outcome measures, so it was not possible to perform meta-analysis. Conclusions There was insufficient evidence to support the hypothesis that patients would benefit from routinely applying a tourniquet. More high-quality randomized controlled trials were needed to test the result. Keywords Tourniquet Anterior cruciate ligament reconstruction System review RCTs Hong Wu and Ling-Xiao Chen have equally contributed to this research. H. Wu L.-X. Chen Y.-L. Li Q. Wu Q.-L. Wu G.-Z. Ning S.-Q. Feng (&) Department of Orthopaedics, Tianjin Medical University, General Hospital, 154 Anshan Road, Heping District, Tianjin 300052, People’s Republic of China e-mail: [email protected]
Introduction Anterior cruciate ligament (ACL) injury was always happened in athletes, especially in competition rather than in practice [1]. In athletes, the incidence of anterior cruciate ligament rupture was three times higher in female than in male [2]. One research pointed out, among United States high school athletes, anterior cruciate ligament injury was ranking third among all involved structures in knee injuries (2.98/10,000 athlete exposures) [1]. There were two ways to treat anterior cruciate ligament injury, one was surgical reconstruction, and the other was non-surgical management. Although some studies showed a considerable percentage of patients with ACL injury continue to participate in furious sports, the majority of studies indicated poor functional outcomes in patients treated non-operatively [3– 5]. The use of tourniquet was first proposed in 1904 and is now a routine procedure in surgery [6]. The effects of tourniquet were the attribute to its ability to improved the surgical field visibility and increased the accuracy of the procedure and reduced surgical time [7]. It had been used in different patient groups, including patients undergoing total knee arthroplasty and patients undergoing foot and ankle surgery [8–11]. The use of tourniquet had been demonstrated to significantly reduce intra-operative blood loss and enhanced thromboembolic complication in total knee arthroplasty and to significantly shorten the hospital length of stay during foot and ankle surgery [8–11]. Anterior cruciate ligament reconstruction is currently performed either with or without a tourniquet depending on the surgeon’s experience [6]. Recently, there were published randomized controlled trials (RCTs) regarding the use of tourniquet in anterior cruciate ligament reconstruction. However, these studies had a small sample size and
123
1000
conveyed uncertain results. So we undertook a system review of published RCTs conducted in anterior cruciate ligament reconstruction to determine whether the use of tourniquet compared with a control benefited the patient.
Methods Data sources We searched Amed (from 1985 to June 2013), British Nursing Index (from 1985 to June 2013), Embase (from 1974 to June 2013) and Pubmed (from 1966 to June 2013). We also searched Scopus, Cochrane Library and Google Scholar. Unpublished literature was also assessed with the search terms ‘‘tourniquet’’ and ‘‘anterior cruciate ligament reconstruction’’ from SIGLE (System for Information on Grey Literature in Europe), the National Technical Information Service, the National Research Register (UK) and the Current Controlled Trials databases. We viewed each reference list for any ignored studies.
Eur J Orthop Surg Traumatol (2014) 24:999–1003
Quality assessment The methodological quality of each trial was evaluated using the revised Jadad scale. The scale consists of 4 items: producing randomization (0–2 points), allocation concealment (0–2 points), blinding (0–2 points) and describing of dropouts and withdrawals (0–1 points) in the report of an RCT. The total score was 7 points; 0–3 points mean poor quality, and 4–7 points mean high quality. Statistical analyses We conducted all statistical analysis using Review Manager 5.2. When we found no evidence of a substantial difference in study populations, interventions and outcome measurements, we performed a meta-analysis. Heterogeneity across studies was tested by using the I2 statistic and a chi-square test. If the data were not homogeneous, metaanalysis was not performed.
Results Inclusion and exclusion criteria Study identification and selection Studies were considered acceptable for inclusion in the system review if they met the criteria: (1) Anterior cruciate ligament reconstruction; (2) RCTs; (3) Tourniquet compared with non-tourniquet group. Trials were excluded if they: (1) were abstracts, letters, or meeting proceedings; (2) had repeated data or did not report outcomes of interest. Study identification All titles and abstracts identified from the search strategy were independently screened by two authors. The full texts for all potentially eligible studies were selected. These were then reviewed by each of the two independent reviewers again to avoid some mistakes occurring.
An initial database search identified a total of 35 RCTs. 17 RCTs were excluded because of duplicate studies, and 13 RCTs were excluded based on the titles and abstracts. The remaining 5 full-text articles were reviewed for more detailed evaluation, 1 of them was also excluded because it was a letter to the editor [12]. Finally, 4 RCTs that met our inclusion criteria were included in the present system review [7, 13–15]. The flowchart of studies included in the system review is shown in Fig. 1.
Articles identified by database and hand research N=35
Excluded(duplicate studies) N=17
Data extraction and outcome measures Titles and Abstracts screened N=18
Two reviewers (Wu and Chen) independently extracted the following data: first author, year of publication, number of patients, patients’ characteristics, use of tourniquet (pressure, time) and outcomes (operation time, blood loss through the intra-articular drain, total blood loss, thigh girth, calf girth, pain score, numbness score, kinetic quadriceps and hamstring strength). Any disagreement was resolved by discussion. If there were still some debates, they consulted further reviewer and expert (Feng) to decide.
123
Excluded: N=13 -Not RCTs: N=5 -No tourniquet vs non-tourniquet: N=8 Full-text articles assessed for eligibility N=5 Full-text articles excluded N=1 Letter to the editor N=1 Articles included N=4
Fig. 1 Flowchart of studies included in system review
Eur J Orthop Surg Traumatol (2014) 24:999–1003
1001
Table 1 Main characteristics References
Sample sizes (T/NT)
Gender (male/female)
Mean age (range), years
Tourniquet parameters
T
NT
T
NT
Pressure (mmHg)
Time (min)
Revised Jadad score
Outcome measures
Hiroshi [7]
51 (28/ 23)
11/17
16/7
24.8 (14–45)
26.7 (15–45)
300
NA
1
Operative time; pain score; numbness score; thigh girth; total blood loss; blood loss through the drain; function testing
Nicholas [14]
48 (25/ 23)
13/12
16/7
33 ± 7
32 ± 9
300
85 ± 7
3
Thigh girth; calf girth; dorsiflexion strength; plantarflexion strength
Hooper [13]
29 (14/ 15)
5/9
10/9
35.3 ± 7.8
35.7 ± 6.6
300
NA
6
Operative time; postoperative morphine; consumption; postoperative pain scores; arthroscopic visibility
Arciero [15]
40 (20/ 20)
13/7
17/3
26 (18–41)
22 (18–34)
269
87
2
Operative time; serum CPK values; thigh and calf girth; isokinetic testing; functional testing
Other outcomes
Table 2 Outcome data References
Hiroshi [7]
Operative time, min
Hiroshi 2013
Tourniquet
Non-tourniquet
115 ± 18
122 ± 17
Nicholas [14]
NA
NA
Hooper [13]
60.8 ± 9.6
65.3 ± 15.5
Arciero [15]
128
137
Characteristics of the studies The main characteristics of the 4 RCTs included in the system review are presented in Table 1, and the outcome data of each included trial are described in Table 2. These studies were published between 1996 and 2013. The size of the RCT ranged from 29 to 51 (total 168). Among the 4 studies included here, 2 reported enough data about operative time [7, 13]. The quality of the included studies was assessed by the revised Jadad score. The median revised Jadad score of the studies included was 3 (range 1–6). Outcome: operative time 3 RCTs reported operative time in study patients [7, 13, 15], but 1 RCT did not supply the SD (Stand Deviation) or the original data so we cannot integrate it [15]. No one defined the operative time. The aggregated results of these studies suggest that there was no significant difference between the tourniquet and the non-tourniquet groups (Fig. 2), and no significant heterogeneity among the studies.
The main outcome measures were blood loss through the intra-articular drain, total blood loss, thigh girth, pain score, numbness score, kinetic quadriceps and hamstring strength. The average blood loss from the suction drain through the suprapatellar pouch was 133.6 ± 62.4 ml (range 60–250 ml) in the tourniquet group and 85.3 ± 47.3 ml (range 20–190 ml) in the non-tourniquet group (P = 0.02). The numbness score which was assessed using a zero to five visual analogue score was significantly elevated in the tourniquet group (P = 0.0002). There were no significant differences in terms of total blood loss, thigh girth, pain score and kinetic quadriceps and hamstring strength. There were no details about the blinding of outcome assessment. Nicholas 2001 The main outcome measures were dorsiflexion strength, plantarflexion strength, calf girth, thigh girth, tourniquet time and strength. The decrease in thigh girth after surgery was greater when the tourniquet was used (2.5 cm, range 1.3–3.7 cm), compared to not using the tourniquet (1.1 cm, range 0.4–1.8 cm; P \ 0.05). There were no significant differences in terms of dorsiflexion strength, plantarflexion strength, calf girth, tourniquet time and strength. There were no reports of neuropathies or complications. 2 patients in each group were not tested because of anterior knee pain.
123
1002
Eur J Orthop Surg Traumatol (2014) 24:999–1003
Fig. 2 Synthesized analysis of operative time, showing no significant difference between tourniquet and non-tourniquet groups, and no significant heterogeneity among the studies
The paper mentioned that the examiners were blinded; however, no details were provided how the blind was made. Hooper 1999 The main outcome measures were postoperative morphine consumption, postoperation pain score, arthroscopic visibility and satisfaction with pain management. The arthroscopic visibility which was assessed by the surgeon was significantly impaired in the non-tourniquet group compared to the tourniquet group (P \ 0.0001). There were no significant differences in terms of postoperative morphine consumption, postoperative pain scores and satisfaction with pain management. For the sake of the absence of femoral nerve block, one patient was lost to analyze. Arciero 1996 The main outcome measures were creatinine phosphokinase (CPK) determination, electromyography, thigh girth, calf girth, KT-1000 arthromeric testing, isokinetic testing of quadriceps and hamstring muscles, single-legged hop test for time, single-legged hop test for distance and the Lysholm knee score. There were no significant differences in terms of all the above parameters. There was no detail about blinding of outcome assessment. One patient was lost to analyze because he refused to take part in the study 2 weeks after surgery. Three of the trails mentioned thigh girth as an outcome measure. Hiroshi et al. [7] did not provide data, but provided a figure which indicated there was no significant difference between two groups. Nicholas et al. and Arciero et al. provided the mean value and the range, but lack of the SD or the original data, in addition, the examined time was different from each other [14, 15]. Two studies used pain score as an outcome measure. However, there were variations in how it was measured and these studies did not supply adequate data to be analyzed [7, 13]. Two of the trials reported calf girth. Nicholas et al. and Arciero et al. provided the mean value and the range with different measured time [14, 15]. Two of the trials examined the strength of quadriceps and hamstring muscles. Hiroshi et al. did not provide data.
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Arciero et al. provided the mean value and the range, but lack of the SD. The two trials had different measured time [7, 15]. None of the trials reported the cost-effectiveness of the use of a tourniquet in anterior cruciate ligament reconstruction. Publication bias Publication bias was not assessed because the number of studies was small (\10).
Discussion The present study showed the surgeons would not achieve shorter operative time by the application of tourniquet. This outcome, however, was assessed in only two studies with small sample size so the lack of a statistical difference might cause by the type 2 statistical error. One trial told us the amount of blood loss through the intra-articular drain was increased in the tourniquet group; however, the amount of total blood loss was no difference between two groups [7]. Because total blood loss was measured based on the postoperation reduction in hemoglobin value, there was a possibility this indirectly measurement could not identify the difference between two groups precisely. There was a need for a large randomized controlled trial with directly measurement to ascertain the effect of the use of tourniquet on total blood loss. No trials reported the occurrence of complications; however, the small size of the trails made us not determine the incidence of potential scarce complications. We recommended more large-scale RCTs to be undertaken so we might find the significant number of rare complications caused by using a tourniquet in anterior cruciate ligament reconstruction. None of the trials mentioned the cost-effectiveness. The operation time which had an important influence on overall costs was not increased in the tourniquet group. In addition, no information was provided about other equipment or training which made the surgery team adjust to the using of tourniquet [16]. There were some strengths in this paper: (1) it is the first system review to explore the role of tourniquet in anterior cruciate ligament reconstruction; (2) all included trails were assessed by revised Jadad score; (3) we used
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comprehensive search strategy although the number of RCTs is limited. This review had several potential limitations that should be taken into account. First, our analysis was based on 4 RCTs, in addition, only two supported enough data to be analyzed, and the sample size was small. Second, only Hooper et al. [13] concealed patient allocation, allocation bias might have influenced results because the patient’s clinical manifestation might have affected the surgeon’s choice of methods before randomisation. Third, Hiroshi et al. and Arciero et al. did not mention the blinding which means both patients and surgeons might have been influenced by each others’ judgement [7, 15]. Finally, all trails had poor methodological quality and design’s deficient except the trail by Hooper et al. [7, 13–15].
Conclusion The limited evidence suggests that the use of tourniquet in anterior cruciate ligament reconstruction may not reduce the operative time. For exploring the efficacy of tourniquet perfectly, well-designed and large RCTs which include the economic evaluation about costing are needed, to ascertain whether the operation time could be reduced, cost-effectiveness of using the tourniquet and the incidence of the rare complications. Conflict of interest of interest.
The authors declare that they have no conflict
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