Double-Bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction

Double-Bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction

D o u b l e - B u n d l e Ve r s u s S i n g l e Bundle Anterior Cruciate Ligament Reconstruction Timo Järvelä, MD, PhD a,b, *, Sally Järvelä, c M...

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D o u b l e - B u n d l e Ve r s u s S i n g l e Bundle Anterior Cruciate Ligament Reconstruction Timo Järvelä,

MD, PhD

a,b,

*, Sally Järvelä,

c MD, PhD

KEYWORDS  Anterior cruciate ligament reconstruction  ACL  Reconstruction  Double-bundle  Single-bundle KEY POINTS  Anatomic and biomechanical studies have shown that the anterior cruciate ligament (ACL) mainly consists of 2 distinct bundles, the anteromedial (AM) bundle and the posterolateral (PL) bundle, which act separately during the knee’s range of motion.  Conventional ACL reconstruction techniques have focused on restoration of the AM bundle only, while giving limited attention to the PL bundle.  In recent years, following the desire to better replicate ACL anatomy and its 2 bundles, many orthopedic surgeons developed double-bundle ACL reconstruction techniques.

INTRODUCTION

Anatomic and biomechanical studies have shown that the anterior cruciate ligament (ACL) mainly consists of 2 distinct bundles, the anteromedial (AM) bundle and the posterolateral (PL) bundle, which act separately during the knee’s range of motion.1–7 Conventional ACL reconstruction techniques have focused on restoration of the AM bundle only, while giving limited attention to the PL bundle. The outcomes of these single-bundle techniques have been relatively good in ACL reconstructive surgery. In recent years, following the desire to better replicate ACL anatomy and its 2 bundles, many orthopedic surgeons developed double-bundle ACL reconstruction techniques. The purpose of this review was to analyze the clinical results of the double-bundle versus single-bundle ACL reconstruction according to the current literature. The main focus in reviewing these clinical studies is on the randomized controlled trials.

a

Sports Clinic, Hospital Mehila¨inen, Ita¨inenkatu 3, FIN-33210 Tampere, Finland; b Tampere University, Teiskontie 35, Tampere 33210, Finland; c Department of Orthopaedics and Traumatology, Tampere University Hospital, Teiskontie 35, Tampere 33210, Finland * Corresponding author. Sports Clinic, Hospital Mehila¨inen, Ita¨inenkatu 3, FIN-33210 Tampere, Finland. E-mail address: [email protected]

Clin Sports Med 32 (2013) 81–91 http://dx.doi.org/10.1016/j.csm.2012.08.009 sportsmed.theclinics.com 0278-5919/13/$ – see front matter Ó 2013 Elsevier Inc. All rights reserved.

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RANDOMIZED CONTROLLED TRIALS

The first prospective, randomized study comparing single-bundle and double-bundle techniques in ACL reconstruction was published by Adachi and colleagues8 in 2004; however, the investigators used only 1 tunnel on the tibial side and 2 tunnels on the femoral side, so the double-bundle technique used in their study was not an anatomic double-bundle ACL reconstruction. They did not find any significant differences concerning knee stability, knee scores, and subjective evaluations between their singlebundle and double-bundle groups at an average of 32-months of follow-up. Aglietti and colleagues9 randomized 75 patients into 3 groups of ACL reconstruction: a single-bundle technique, a double-bundle with transtibial technique, and a double-bundle with a double-incision technique. They found significantly better rotational and anterior stability at the 2-year follow-up using the double-bundle with double-incision technique compared with the transtibial double-bundle or singlebundle techniques. In the other prospective, randomized study of Aglietti and colleagues10 published in 2010, they compared single-bundle and double-bundle ACL reconstruction with a double-incision technique in both groups with 70 patients. At a minimum of 2-year follow-up, the double-bundle group had significantly better visual analog scale for pain, anterior knee stability, and knee scores than the single-bundle group. Ja¨rvela¨11 compared his anatomic double-bundle technique with hamstring grafts and bioabsorbable screw fixation with his single-bundle ACL reconstruction using similar fixation and graft material in a prospective, randomized study of 65 patients (Figs. 1 and 2). The anteromedial portal and freehand technique were used in both groups to create the femoral tunnels as anatomically as possible. At a minimum of 1-year follow-up, the rotational stability, as evaluated by the pivot shift, was significantly better in the double-bundle group than in the single-bundle group. However, the anterior stability and the International Knee Documentation Committee (IKDC) and Lysholm knee scores were equally good in both groups. In another prospective, randomized study of Ja¨rvela¨ and colleagues,12 77 patients were divided into 3 groups: single-bundle with metallic screw fixation, single-bundle with bioabsorbable screw fixation, and double-bundle with bioabsorbable screw fixation. At a minimum of 2-year follow-up, the rotational stability was best in the doublebundle group. In addition, the patients in the single-bundle groups had 6 graft failures leading to revision ACL surgery, whereas only 1 patient in the double-bundle group had a graft failure. These differences were significant. In the third prospective, randomized study of Ja¨rvela¨ and colleagues,13 60 patients were divided into either double-bundle or single-bundle ACL reconstruction using

Fig. 1. Arthroscopic view of the left knee showing tunnel placements of the single-bundle ACL reconstruction on the tibial side (left) and on the femoral side (right).

Anterior Cruciate Ligament Reconstruction

Fig. 2. Schematic view of the right knee showing the tunnel and screw placements of the double-bundle ACL reconstruction.

hamstring autografts and bioabsorbable screw fixation in both groups. At the minimum of 2-year follow-up, the double-bundle group had significantly less tunnel enlargement in the tibial side evaluated by magnetic resonance imaging (MRI) than the single-bundle group; however, there were no differences in the stability evaluations or the IKDC and Lysholm knee scores between the groups. Yagi and colleagues14 randomized 60 patients into 3 groups: an anteromedial bundle reconstruction group, a posterolateral bundle reconstruction group, and a double-bundle reconstruction group. All the patients were examined 1 year after surgery. Anterior stability and the IKDC knee scores were equal in each group; however, rotational stability, as evaluated by the pivot shift and by 3-dimensional electromagnetic sensors, was best in the double-bundle group. Muneta and colleagues15 randomized 68 patients into double-bundle or singlebundle ACL reconstruction groups. At the 2-year follow-up, the double-bundle group had significantly better rotational and anterior stability than the single-bundle group, although no differences were found in the subjective knee scores. Streich and colleagues16 randomized 50 male athletes into anatomic double-bundle or anatomic single-bundle (low femoral tunnel) ACL reconstruction. At the 2-year follow-up, no significant differences were found between the groups concerning rotational and anterior stability of the knee. Also, the objective and subjective knee scores were equal in both groups. The investigators concluded that ACL reconstruction with a single-bundle technique and more horizontal femoral tunnel placement obtained comparable clinical results than those with a double-bundle technique in highdemand athletes.

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Siebold and colleagues17 randomized 70 patients into double-bundle or single-bundle ACL reconstruction. At an average of 19 months of follow-up, the double-bundle group had significantly better rotational and anterior stability than the single-bundle group. Also, the objective IKDC score was significantly better in the double-bundle group, although no differences were found in the subjective knee scores. Sastre and colleagues18 randomized 40 patients into double-bundle or singlebundle ACL reconstruction with an anatomic low femoral tunnel position in both techniques. At the 2-year follow-up, no differences were found between the groups in anterior or rotational stability or in the IKDC knee scores. Zaffagnini and colleagues19 randomized 100 patients into double-bundle or singlebundle ACL reconstruction with extra-articular augmentation on the lateral side of the knee. Seventy-two patients were available for 3-year follow-up. The double-bundle group showed significantly better results in terms of subjective, objective, and functional evaluations of the knee. Also, anterior stability was significantly better in the double-bundle group compared with the single-bundle group. Zaffagnini and colleagues20 have published another prospective randomized study. In that study, 79 patients were evaluated with a minimum of 8-year follow-up; however, the double-bundle technique they used was nonanatomic with only one tunnel on the femoral and tibial side combined with one “over-the-top” passage of the graft. The investigators concluded that although both the single-bundle and the nonanatomic double-bundle techniques provided satisfactory results, the nonanatomic double-bundle reconstruction showed significantly better functional results with a faster return to sports activity, a lower reoperation rate, and lower degenerative knee changes determined radiographically than the single-bundle technique. Wang and colleagues21 randomized 64 patients into double-bundle or singlebundle ACL reconstruction using hamstring grafts and cortical fixation on the femoral side. At the 10-month follow-up, no differences were found between the groups in anterior or rotational stability or in the IKDC knee scores. Ibrahim and colleagues22 randomized 218 patients with unilateral ACL deficiency into 4 groups: one group was performed with an anatomic double-bundle technique and the 3 other groups with single-bundle techniques using different fixation methods in each group on the femoral side (Endobutton [Smith & Nephew, USA], RigidFix [DePuy Mitek, USA], TransFix [Arthrex, USA]). For tibial fixation, a bioabsorbable screw fixation was used in all patients. Also, hamstring autografts were used in all patients. At a mean of 29-month follow-up, the double-bundle method showed significantly better rotational and anterior stability, as evaluated by the pivot shift test and by KT-1000 (San Diego, CA, USA), measurements, compared with the single-bundle methods. However, no differences were found in the IKDC knee scores between the groups. Suomalainen and colleagues23 compared the double-bundle technique with hamstring autografts and aperture screw fixation with single-bundle ACL reconstruction using similar fixation and graft material in a prospective, randomized study of 153 patients. At a minimum of 2-year follow-up, the revision rate was significantly lower with the double-bundle technique than that with the single-bundle technique (7 revision ACL reconstructions in the single-bundle group, and 1 revision in the double-bundle group). In addition, 7 patients (5 in the single-bundle group and 2 in the double-bundle group) had an invisible graft on the MRI assessment at the 2-year follow-up; however, no differences were found in the IKDC or Lysholm knee scores between the groups. Also, the stability evaluations did not show any significant differences between these 2 techniques at the follow-up. Araki and colleagues24 randomized 20 patients into anatomic single-bundle or double-bundle ACL reconstruction. At the 1-year follow-up, there were no significant

Anterior Cruciate Ligament Reconstruction

differences between the groups in the clinical stability evaluations or Lysholm knee scores. According to the 6-degrees-of-freedom of knee kinematic measurement system using an electromagnetic device, however, the double-bundle technique tended to have biomechanically better results than the anatomic single-bundle technique. Fujita and colleagues25 randomized 55 patients into 3 groups of ACL reconstruction: an anteromedial bundle reconstruction, a posterolateral bundle reconstruction, and a double-bundle reconstruction. At the minimum of 2-year follow-up, the patients undergoing double-bundle ACL reconstruction had significantly better anterior stability than the patients having a single-bundle posterolateral reconstruction, whereas in the pivot shift test, the posterolateral reconstruction group had fewer negative results than the double-bundle reconstruction group; however, the anteromedial bundle reconstruction group (conventional single-bundle reconstruction) had results similar to the double-bundle reconstruction group concerning both the anterior and rotatory stability of the knee. The investigators concluded that, overall, the clinical outcome, as measured by Lysholm and Tegner scores, was not different among the groups. Hussein and colleagues26 randomized 281 patients into 3 groups of ACL reconstruction: a conventional single-bundle group, an anatomic single-bundle group, and an anatomic double-bundle ACL reconstruction group. At 3-year to 5-year follow-up, the anatomic double-bundle technique resulted in significantly better anterior stability measured by KT-1000 arthrometer, and significantly better rotational stability as evaluated by pivot shift test than the conventional and anatomic singlebundle techniques. Also, the Lysholm knee score was significantly better with the anatomic double-bundle technique than with the conventional single-bundle technique. The investigators concluded that the anatomic double-bundle ACL reconstruction was significantly superior to conventional single-bundle ACL reconstruction and better than anatomic single-bundle reconstruction, although the differences were small and might not be clinically relevant. Lee and colleagues27 randomized 42 patients into single-bundle or double-bundle ACL reconstruction. They used a navigation system to measure anterior and rotatory laxity of the knee before and after the fixation of the graft during reconstruction, and found that the double-bundle ACL reconstruction improved rotatory laxity significantly better than the single-bundle technique. However, at the 2-year follow-up, there was no group-difference in functional outcome. All of the randomized, controlled trials comparing double-bundle and single-bundle ACL reconstruction are summarized in Table 1. PREVIOUS SYSTEMATIC REVIEWS

In 2008, Meredick and colleagues28 published a meta-analysis of randomized controlled trials comparing single-bundle versus double-bundle ACL reconstruction. According to their meta-analysis of the 4 level I studies published in the literature, double-bundle reconstruction did not result in clinically significant differences in KT-1000 measurements for anterior stability or in pivot-shift testing for rotational stability. They concluded that the results do not support the theory that doublebundle reconstruction better controls knee rotation; however, the investigators grouped “normal” and “nearly normal” outcome together, which was criticized and discussed later in the literature.29 Yasuda and colleagues30 published a current concepts review of the anatomic double-bundle ACL reconstruction. They reported the results of 10 prospective, randomized studies comparing single-bundle and double-bundle ACL reconstruction.

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Table 1 Randomized controlled trials comparing double-bundle (DB) and single-bundle (SB) anterior cruciate ligament reconstruction Authors

Year Number of Follow-up Published Patients Time Results

Adachi et al8

2004

108

32 mo

No difference

Aglietti et al9

2007

75

2y

Better rotational and anterior stability in DB-group

Aglietti et al10

2010

70

2y

Better anterior stability and subjective and objective knee scores in DB-group

Ja¨rvela¨11

2007

65

14 mo

Better rotational stability in DB-group

Ja¨rvela¨ et al12

2008

77

2y

Better rotational stability and fewer graft failures in DB group

Ja¨rvela¨ et al13

2008

60

2y

Less tunnel enlargement in DB group

Yagi et al14

2007

60

1y

Better rotational stability in DB group

Muneta et al15

2007

68

2y

Better rotational and anterior stability in DB group

Streich et al16

2008

50

2y

No difference

Siebold et al17

2008

70

19 mo

Better rotational and anterior stability and objective knee scores in DB group

Sastre et al18

2010

40

2y

No difference

Zaffagnini et al19

2008

100

3y

Better anterior stability and objective and subjective knee scores in DB group

Zaffagnini et al20

2010

79

8y

Better functional scores and fewer graft failures and less degenerative changes in DB group

Wang et al21

2009

64

10 mo

No difference

Ibrahim et al22

2009

218

29 mo

Better rotational and anterior stability in DB group

Suomalainen et al23 2011

153

2y

Fewer graft failures in DB group

Araki et al24

2011

20

1y

No difference

Fujita et al25

2011

55

2y

No difference

Hussein et al26

2011

281

51 mo

Better rotational and anterior stability in DB group

Lee et al27

2012

42

2y

Better rotational stability in DB group

In 8 of the 10 studies, the anterior and/or rotational stability of the knee was significantly better with the anatomic double-bundle ACL reconstruction than with the conventional single-bundle reconstruction; however, many controversies concerning the surgical techniques remain in the field of anatomic double-bundle ACL reconstruction. There were many differences in procedures for creating anatomic tunnels, graft preparation, tensioning, and fixation among the clinical trials included in the review.

Anterior Cruciate Ligament Reconstruction

Yasuda and colleagues30 concluded that the utility of the anatomic double-bundle reconstruction has not yet been established. Boyer and Meislin31 published a review of double-bundle versus single-bundle ACL reconstruction in 2010. They included both retrospective nonrandomized studies and prospective randomized studies comparing double-bundle and single-bundle ACL reconstruction. They criticized a large variability of the methodology of these studies. Also, several different surgical techniques were represented, which made pooling the data difficult. They concluded that there is a need for more standardization of measuring parameters and the future application of advanced technologies that would inform more correct models how to improve the techniques of ACL reconstruction. Ja¨rvela¨ and Suomalainen32 published a review comparing the clinical results between double-bundle and single-bundle ACL reconstruction. They reported 14 randomized controlled trials found from the literature comparing the clinical results of these 2 techniques. According to their review, 4 trials (29%) did not find any significant differences in the results between double-bundle and single-bundle ACL reconstruction. Ten trials (71%) reported significantly better results with the double-bundle technique than with the single-bundle technique, of which 7 reported better rotational stability, 6 reported better anterior stability, 3 reported better objective knee scores, 3 reported better subjective knee scores, 2 reported fewer graft failures, and 1 reported fewer degenerative changes of the knee. In addition, none of the trials found the singlebundle technique to have better results in any of these evaluations than the doublebundle technique; however, 13 of the 14 trials had only a short-term follow-up (1–3 years), and only 1 trial had a long-term follow-up (8–10 years). They concluded that only through long-term follow-up studies will we be able to determine whether the double-bundle reconstruction is really better than the single-bundle technique. Longo and colleagues33 published a systematic review comparing single-bundle and double-bundle ACL reconstruction. They found that double-bundle ACL reconstruction could provide better outcome for patients in terms of closer restoration of normal knee biomechanics and improving the rotatory laxity of the knee; however, they did not recommend the systematic use of double-bundle ACL reconstruction for patients, because even though biomechanical results are encouraging, subjective patient evaluation is similar for single-bundle and double-bundle ACL reconstruction. They concluded that with the current evidence available, a simple single-bundle ACL reconstruction is a suitable technique, and it should not be abandoned until stronger scientific evidence in favor of double-bundle ACL reconstruction is produced. Kongtharvonskul and colleagues34 published a systematic review of randomized controlled trials comparing clinical outcomes of double-bundle versus single-bundle ACL reconstruction. They included 13 studies in their review. They reported that the double-bundle technique was approximately 4 times more likely to show a normal pivot shift than the single-bundle technique. Also, the IKDC grading was 2 times better with the double-bundle technique. They concluded that the double-bundle ACL reconstruction may be better than the single-bundle technique in rotational stability but not for function, translation, and complications. DISCUSSION

According to the 20 prospective, randomized studies found from the English literature and included into this review, 6 studies (30%) did not find any significant differences in the clinical results between double-bundle and single-bundle ACL reconstructions; however, 14 studies (70%) reported significantly better results with the doublebundle technique than with the single-bundle technique. Nine of these trials reported

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better rotational stability, 7 trials noted better anterior-posterior stability, 3 trials showed better objective knee scores, 3 trials had better subjective knee scores, 3 trials had fewer graft failures, 1 trial had less tunnel enlargement, and 1 trial was found to have fewer degenerative changes in the knee joint with the double-bundle technique compared with the single-bundle technique. In addition, none of the studies found that the single-bundle technique had better results in any of these evaluations than the double-bundle technique. Although the current scoring systems may not be very sensitive in finding differences between double-bundle and single-bundle techniques, and there is a large variation between the techniques and terminology used in the ACL double-bundle surgery (nonanatomic vs anatomic), it appears that the double-bundle ACL reconstruction is either equal to or significantly better than the single-bundle ACL reconstruction. There are some risks associated with the double-bundle technique, however. Because there are more tunnels to be created, and more grafts to be fixed, the double-bundle technique provides more opportunity to have some technical difficulties or failures during the operation than the traditional single-bundle technique. The double-bundle ACL reconstruction can be a very demanding procedure with increased costs associated with a need for more fixation material, grafts, and a longer operation time, as well as potential complications related to the steep learning curve for the surgeon. That is why the double-bundle technique is not recommended for every ACL surgeon but only for the hands of the most experienced ACL surgeons. Also, the size of the knee is important when making the decision as to whether to use the double-bundle or single-bundle technique in ACL reconstruction. If the knee is very small, there is no room to perform a good double-bundle ACL reconstruction. Then, it is better to make an anatomic single-bundle ACL reconstruction. In addition, if the hamstring autografts, especially the gracilis tendon graft, are very thin, and allograft is not available, it is better to make 1 good graft than 2 very thin grafts. The minimum diameter for the PL-bundle graft should be 5 to 6 mm, and for the AMbundle 6 to 7 mm, respectively. The activity level of the patient may have some importance in deciding which technique to use in ACL reconstruction. Patients with a high activity level may have some benefit from the double-bundle ACL reconstruction, because almost half of the prospective randomized studies included in this review reported that the doublebundle technique resulted in significantly better stability of the knee than the singlebundle technique. Especially athletes who perform demanding pivoting sports (eg, ball games, skiing, gymnastics) could have a more stable knee with the doublebundle technique compared with the single-bundle technique. Also, the injury model of the knee plays a role in the decision of which technique to use. Musahl and colleagues35 showed in their cadaveric study that the double-bundle

Table 2 Suggested indications for anatomic single-bundle versus double-bundle ACL reconstruction Single-bundle ACL Reconstruction

Double-bundle ACL Reconstruction

Small knee (not room for the DB technique)

Large enough knee

Thin hamstring tendons

Good quality of the hamstring tendons

Nonathlete or

High-level athlete

Recreational athlete

Pivoting sports

Isolated ACL injury

ACL injury combined with meniscal injury

Anterior Cruciate Ligament Reconstruction

ACL reconstruction was able to restore intact knee kinematics during the pivot shift testing significantly better than the anatomic single-bundle or nonanatomic singlebundle technique in the setting of ACL injury and concomitant medial and lateral meniscus deficiency. SUMMARY

According to this systematic review of prospective, randomized studies comparing double-bundle and single-bundle ACL reconstruction, 6 studies (30%) did not find any significant differences in the clinical results between these techniques. However, 14 studies (70%) reported significantly better results with the double-bundle technique than with the single-bundle technique. In addition, none of the studies showed the single-bundle technique to have better results than the double-bundle technique. However, double-bundle surgery may not yet be a standard procedure for every surgeon or for every patient until stronger scientific evidence with longer follow-ups in favor of double-bundle ACL reconstruction is produced. The suggested indications for the anatomic double-bundle and single-bundle ACL reconstruction are presented in Table 2. REFERENCES

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27. Lee S, Kim H, Jang J, et al. Comparison of anterior and rotatory laxity using navigation between single- and double-bundle ACL reconstruction: prospective randomized trial. Knee Surg Sports Traumatol Arthrosc 2012;20(4):752–61. 28. Meredick RB, Vance KJ, Appleby D, et al. Outcome of single-bundle versus double-bundle reconstruction of the anterior cruciate ligament: a meta-analysis. Am J Sports Med 2008;36:1414–21. 29. Irrgang JJ, Bost JE, Fu FH. Re: outcome of single-bundle versus double-bundle reconstruction of the anterior cruciate ligament: a meta-analysis. Am J Sports Med 2009;37:421–2. 30. Yasuda K, Tanabe Y, Kondo E, et al. Anatomic double-bundle anterior cruciate ligament reconstruction. Arthroscopy 2010;26(Suppl 9):S21–34. 31. Boyer J, Meislin RJ. Double-bundle versus single-bundle ACL reconstruction. Bull NYU Hosp Jt Dis 2010;68:119–26. 32. Ja¨rvela¨ T, Suomalainen P. ACL reconstruction with double-bundle technique: a review of clinical results. Phys Sportsmed 2011;39:85–92. 33. Longo UG, Buchmann S, Franceschetti E, et al. A systematic review of singlebundle versus double-bundle anterior cruciate ligament reconstruction. Br Med Bull 2012;103:147–68. 34. Kongtharvonskul J, Attia J, Thamakalson S, et al. Clinical outcomes of double- vs single-bundle anterior cruciate ligament reconstruction: a systematic review of randomized control trials. Scand J Med Sci Sports 2012. http://dx.doi.org/ 10.1111/j.1600–0838.2011.01439.x. 35. Musahl V, Bedi A, Citak M, et al. Effect of single-bundle and double-bundle anterior cruciate ligament reconstructions on pivot-shift kinematics in anterior cruciate ligament- and meniscus-deficient knees. Am J Sports Med 2011;39:289–95.

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