Orthopedics

Feature Article 

Confirmation of Femoral Button Deployment Under Direct Visualization During ACL Reconstruction Is Not Beneficial

Sueen Sohn, MD; In Jun Koh, MD, PhD; Man Soo Kim, MD; Yong In, MD, PhD

Abstract

The purpose of this study was to determine whether direct visualization of adjustable-loop cortical suspensory button deployment onto the lateral femur increases the cortical contact rate of the button, thereby improving clinical outcomes after anterior cruciate ligament (ACL) reconstruction. Sixty-five single-bundle anteromedial portal ACL reconstructions using an adjustable-loop button were retrospectively divided into 2 groups according to use of the blind pulling technique (control group; 32 patients) or the direct visualization technique (visualization group; 33 patients) when confirming deployment of the button. Cortical contact rate of the button on immediate and 2-year postoperative radiographs, knee stability measured using a KT-1000 arthrometer, and functional scores (Lysholm score and International Knee Documentation Committee score) at 2 years postoperative were compared between the groups. There was no significant difference in femoral cortical contact rate between the groups immediately (56% control group vs 55% visualization group; P=1.000) and at 2 years postoperative (78% control group vs 82% visualization group; P=.764). At 2 years postoperative, there was no difference between the groups regarding knee stability (1.3±0.9 mm vs 1.5±0.8 mm, respectively; P=.404), Lysholm score (P=.436), and International Knee Documentation Committee score (P=.507). Confirmation of adjustable-loop button deployment under direct visualization during anteromedial portal ACL reconstruction neither increased cortical contact rate nor improved clinical outcomes. [Orthopedics. 2020;43(5);270–276.]

Abstract

The purpose of this study was to determine whether direct visualization of adjustable-loop cortical suspensory button deployment onto the lateral femur increases the cortical contact rate of the button, thereby improving clinical outcomes after anterior cruciate ligament (ACL) reconstruction. Sixty-five single-bundle anteromedial portal ACL reconstructions using an adjustable-loop button were retrospectively divided into 2 groups according to use of the blind pulling technique (control group; 32 patients) or the direct visualization technique (visualization group; 33 patients) when confirming deployment of the button. Cortical contact rate of the button on immediate and 2-year postoperative radiographs, knee stability measured using a KT-1000 arthrometer, and functional scores (Lysholm score and International Knee Documentation Committee score) at 2 years postoperative were compared between the groups. There was no significant difference in femoral cortical contact rate between the groups immediately (56% control group vs 55% visualization group; P=1.000) and at 2 years postoperative (78% control group vs 82% visualization group; P=.764). At 2 years postoperative, there was no difference between the groups regarding knee stability (1.3±0.9 mm vs 1.5±0.8 mm, respectively; P=.404), Lysholm score (P=.436), and International Knee Documentation Committee score (P=.507). Confirmation of adjustable-loop button deployment under direct visualization during anteromedial portal ACL reconstruction neither increased cortical contact rate nor improved clinical outcomes. [Orthopedics. 2020;43(5);270–276.]

Femoral fixation devices for soft tissue anterior cruciate ligament (ACL) graft have been developed.1–4 TightRope (Arthrex, Naples, Florida) is a second-generation cortical suspensory fixation device for ACL reconstruction. It has an adjustable loop that can be tensioned after deployment of the button to fit all sizes of femoral tunnels.5–7 Because it lacks the side trailing suture for flipping and has a longer loop, Tight-Rope is associated with more concerns about soft tissue impingement between the button and the femoral cortex than the fixed-length loop device.8,9 Early necrosis of interposed tissue before integration of graft with the bone may increase graft-tunnel motion and disturb graft-to-bone healing.10,11

Various techniques have been suggested to avoid soft tissue interposition and confirm deployment of the button.10,12–18 Among them, the direct visualization technique is highly reliable and usable, permitting not only observation of the button and structures around the femoral exit but also arthroscopic operations for soft tissues.10,16–18 However, predominantly only the technical aspects of the procedure, and not the efficacy or clinical correlations acquired through practice, have been reported. Moreover, recent studies have described the use of retrograde-cutting devices to create a femoral tunnel, being of no use to surgeons lacking such devices.17–20

The current authors believe that research is lacking on the clinical efficacy of the direct visualization technique in ACL reconstruction under antegrade femoral tunneling via the anteromedial (AM) portal. Thus, the purpose of this study was to identify whether confirmation of TightRope button deployment with direct visualization increased the cortical contact rate of the button, thereby improving clinical outcomes following single-bundle AM portal ACL reconstruction. The authors hypothesized that the direct visualization technique would increase the cortical contact rate of the button and that clinical outcomes would be superior in the direct visualization group compared with the non-visualization group.

Materials and Methods

Patients

This retrospective comparative study had the following inclusion criteria: (1) consecutive primary ACL reconstructions from 2013 to 2016 using TightRope for femoral fixation; (2) use of a single-bundle AM portal technique with autogenous hamstring tendon; and (3) patient follow-up of 2 years. A total of 78 patients were identified: 40 had the conventional blind pulling technique from 2013 to 2014 and 38 had arthroscopic direct visualization from 2015 to 2016. Nine patients were excluded: 4 with revisional ACL reconstructions, 2 with combined high-grade other ligamentous injuries, 2 with ACL reconstructions following high tibial osteotomy, and 1 with early re-rupture within 2 years. After 4 patients who were lost to follow-up were removed, 65 patients were finally enrolled. The patients were divided into 2 groups; the control group consisted of 32 patients with the blind pulling technique and the visualization group consisted of 33 patients with direct visualization. This study received institutional review board approval. All patients gave informed consent.

Surgical Procedures and Rehabilitation

All operations were performed by a single experienced surgeon (Y.I.). The femoral tunnel guide pin was consistently aimed at the high AM bundle point using a 7-mm offset ACL guide (Arthrex) via the AM portal with the knee flexed at 120°. After measuring the femoral condylar length, a 25-mm–deep femoral socket was created with a cannulated headed reamer. The tibial tunnel was created with conventional methods. The leading suture of the TightRope was passed from the tibial tunnel through the femoral tunnel toward the lateral thigh. In the control group, with the knee flexed at 90°, the leading suture was pulled upward to make the button pass the femoral cortex while holding the tibial end of the graft to avoid over-pulling. The graft was then pulled back and forth several times to flip and seat the button onto the femoral cortex. Subsequently, the tensioning loop was pulled to tightly engage the graft into the femoral socket. In the visualization group, after pulling the leading suture upward, a supero-lateral-posterior joint arthrotomy was made with a motorized shaver inserted via the superolateral portal. An arthroscope was inserted via the standard anterolateral portal and passed through the supero-lateral-posterior arthrotomy to find the button with the use of the shaver. Unnecessary impinged soft tissues were removed using a shaver. After confirming secure seating of the button onto the lateral femur, final tensioning of the loop was performed. In both groups, cyclic loading was applied 20 times while pulling the graft distally. Finally, the tibial end of the graft was fixed using a bioabsorbable interference screw and a spiked-washer/cancellous screw with the knee in full extension.

Patients who underwent ACL reconstruction only or with meniscectomy were permitted to perform full range of motion exercise and partial weight bearing with crutches. Continuous passive motion exercise and non–weight bearing were recommended for patients with concomitant meniscal repair for 6 weeks. For all ACL reconstructions, full weight bearing was started at 6 weeks after the surgery.

Radiographic Evaluation

Immediate and 2-year postoperative radiographs were reviewed to evaluate the presence of the TightRope button in the state of cortical contact. Cortical contact was defined as when both ends of the button had come into contact with the femoral cortex or on the central area, or when the gap between the button and the cortex was 1 mm or less at more than two-thirds of the length of the button (Figure 1). Central referred to the area between the 2 stitch holes of the button. Cortical non-contact was defined as when the gap exceeded 1 mm at more than two-thirds of the button. The shortest distance from the center of the button to the femoral cortex was the gap distance. Two orthopedic surgeons (I.J.K., M.S.K.) reviewed radiographs independently twice within an interval of 4 weeks. All radiographic measurements were conducted on PACS (Picture Archiving and Communications System; M-View; Marotech, Seoul, Korea) with an automated distance calculation tool of which the minimum measurement unit was 0.1 mm. To evaluate the agreement in interpretation between the 2 reviewers, kappa statistics and intraclass correlation coefficients (ICCs) were employed.

Immediate postoperative anteroposterior radiographs of the knee. Three types of cortical contact—both ends (A), central area (B), and a gap distance of 1 mm or less (C)—and cortical non-contact (D) are shown.

Figure 1:

Immediate postoperative anteroposterior radiographs of the knee. Three types of cortical contact—both ends (A), central area (B), and a gap distance of 1 mm or less (C)—and cortical non-contact (D) are shown.

Clinical Evaluations

Clinical outcomes were evaluated annually postoperatively by orthopedic fellows who were blinded to the technique received by the patients. A KT-1000 arthrometer (MEDmetric, San Diego, California) was used to evaluate postoperative knee stability. This test was performed repetitively to converge the mean laxity on each side of the knee. Lysholm score and International Knee Documentation Committee (IKDC) score were used to evaluate functional outcomes.

Statistical Methods

To reveal a 1-mm side-to-side difference, at least 32 patients were required in each group to achieve 80% power with an alpha of 0.05.21 The Mann–Whitney test was used to compare continuous variables between groups. Fisher’s exact test was used to compare categorical variables. SPSS version 21.0 software (SPSS Inc, Chicago, Illinois) was used for all statistical analyses. Statistical significance was set at P<.05.

Results

Regarding preoperative demographics, male dominance was found in the visualization group (63% in the control group vs 97% in the visualization group, P=.001). However, other variables, including age, graft size, tourniquet time, and incidence of meniscal injury, showed no significant differences between the 2 groups (P>.05) (Table 1).

Demographics and Operative Data of the Control and Visualization Groups

Table 1:

Demographics and Operative Data of the Control and Visualization Groups

Immediate postoperative radiographs revealed that the cortical contact rate was 56% in the control group and 55% in the visualization group (P=1.000) (Table 2; Figure 2). At 2 years postoperative, the cortical contact rate had increased to 78% in the control group and 82% in the visualization group, indicating no significant difference between the groups (P=.764). The average gap distance measured for cortical non-contact cases was not significantly different between the control group and the visualization group immediately (P=.827) or at 2 years postoperative (P=.945). Kappa statistics and ICC showed excellent agreement (kappa=0.907 and ICC=0.951, P<.001).

Radiographic Results of the Control and Visualization Groups Immediately Postoperative and 2 Years Postoperative

Table 2:

Radiographic Results of the Control and Visualization Groups Immediately Postoperative and 2 Years Postoperative

Illustration of an arthroscope inserted via the anterolateral portal and an arthroscopic shaver inserted via the superolateral portal (A). Arthroscopic image during the direct visualization technique showing secure seating of the button (B). Postoperative anteroposterior radiograph of the knee of the same patient showing cortical non-contact of the button (gap distance, 2.2 mm) (C).

Figure 2:

Illustration of an arthroscope inserted via the anterolateral portal and an arthroscopic shaver inserted via the superolateral portal (A). Arthroscopic image during the direct visualization technique showing secure seating of the button (B). Postoperative anteroposterior radiograph of the knee of the same patient showing cortical non-contact of the button (gap distance, 2.2 mm) (C).

At 2 years postoperative, neither knee stability as side-to-side difference (1.3±0.9 mm vs 1.5±0.8 mm for the control group and the visualization group, respectively; P=.404) nor functional outcomes (Lysholm score, P=.436; IKDC score, P=.507) were significantly different between the groups (Table 3).

Knee Stability and Clinical Outcomes of the Control and Visualization Groups at 2 Years Postoperative

Table 3:

Knee Stability and Clinical Outcomes of the Control and Visualization Groups at 2 Years Postoperative

In a subgroup analysis based on immediate postoperative radiographs, the buttons of 36 patients were found to be in contact with the femoral cortex (contact subgroup) and those of 29 patients were not (non-contact subgroup). The contact subgroup and the non-contact subgroup showed no significant difference in knee stability and functional outcomes at 2 years after the reconstruction (Table 4).

Demographics and Clinical Outcomes at 2 Years Postoperative for the Contact and Non-contact Subgroups

Table 4:

Demographics and Clinical Outcomes at 2 Years Postoperative for the Contact and Non-contact Subgroups

Discussion

The main finding of this study was that direct visualization of TightRope button deployment did not increase the cortical contact rate following single-bundle ACL reconstruction under antegrade femoral tunneling via the AM portal. In contrast to the authors’ hypothesis, the cortical contact rate and clinical outcomes of the visualization group were not superior to those of the control group. Complications such as irritations or persistent pain associated with soft tissue impingement were not found in either group.22,23

Despite direct visualization, nearly half (45%) of the visualization group showed cortical non-contact on immediate postoperative radiographs. This result may have been related to the authors’ surgical principle: the purpose of direct visualization was not to perform an obligatory thorough debridement around the femoral exit but rather to confirm the secure seating of the button without soft tissue impingement. Debridement was performed around the button for abnormal fat or tendinous tissues other than normal fibrous periosteum of the femoral cortex. In the visualization group, debridement was performed in all cases during confirmation of seating of the button; however, no case received thorough debridement exposing the cortical bone. To avoid inadvertent destruction of the adjustable loop with the arthroscopic shaver during debridement, the impinged tissue was cautiously dissected by a curette or probe prior to applying the shaver. Although some authors have suggested the thorough removal of soft tissue by curettage or radiofrequency until the cortical bone beneath the button is exposed,18,24 it is currently unclear whether interposition of normal fibrous or synovial tissue leads to detrimental results.25 Given that the cortical non-contact rate of the visualization group was similar to that of the control group, it seems inevitable that non-contact of the button would occur at a certain rate. One of the reasons may be the position of the lateral cortical exit of the femoral tunnel, which was placed at an extra-articular space, more proximal and posterior than that in retrograde femoral tunneling.

Gap distance measured in non-contact cases of the control and visualization groups showed a similar average value and distributions. Gap distance was between 1 and 3 mm in a majority of non-contact cases, and there was no severe outlier. Only one case in the control group showed more than 3 mm of gap distance (3.1 mm). However, this patient had excellent knee stability (side-to-side difference, 0 mm) and functional outcomes (Lysholm score, 100; IKDC score, 95.4) at 2 years postoperative. Previous studies have suggested a permissible gap of 1 mm by taking the periosteum into consideration.24,25 Another study set a gap of more than 2 mm as “suboptimal,” but the criterion was based on the authors’ estimation.12 Although an acceptable gap has not been established because of insufficient evidence, the small gap distance observed universally in both of the current groups would have contributed to favorable clinical outcomes in this study. Additional comparison between the contact subgroup and the non-contact subgroup regarding the effect of cortical non-contact showed no differences between them. Therefore, it may be suggested that cortical non-contact with a gap of less than 3 mm would not be associated with inferior clinical outcomes in the short-term.

At 2 years postoperative, changes in contact rate and average value and distributions of gap distance were similar between the groups. Despite direct visualization, a change in button position could not be prevented. The results suggest that normally interposed soft tissue may shrink or necrotize over time but do not necessarily indicate loosening of graft tension. If such changes were to occur after a critical period for the tendon-to-bone healing (8 to 12 weeks), they would have no effect on joint stability.26 Although the timing of the change in button position was not investigated in this study, the authors’ results regarding knee stability and functional outcomes were comparable with those of previous clinical studies.21,27,28

Technically, several concerns exist regarding performing direct visualization. First, soft tissue injury around the lateral femoral cortex is unavoidable while searching for the button. Not only the iliotibial band and the vastus lateralis, which should be dissected or undermined by a shaver or arthroscope, but also the lateral head of the gastrocnemius or the biceps femoris can be involved.8,16,29 Second, introduction of fluid into the extra-articular space may cause complications ranging from edema to compartment syndrome. Third, the leading suture of TightRope can be damaged by a motorized shaver. Fourth, despite efforts, the button may not be successfully found.17 Thus, it is uncertain whether the direct visualization technique has advantages over the blind technique, given the risks and comparable outcomes in the control group.

This study had several limitations. First, this was a retrospective study, although all patients were evaluated using the authors’ uniform follow-up protocols. Second, the number of patients was relatively small. Although the sample size was statistically sufficient, a larger number of patients for each group would decrease the risk of type II error. Third, determination of the cortical contact state was performed based on plain radiography only. However, the authors believe that computed tomography imaging is not a proper tool because of its vulnerability to metallic artifacts and the unnecessary radiation hazard to patients. Despite the aforementioned limitations, this is the first study to assess the efficacy of the direct visualization technique in ACL reconstruction using TightRope.

Conclusion

Direct visualization of TightRope button deployment onto the lateral femur during ACL reconstruction neither increased cortical contact rate nor improved clinical outcomes compared with the blind technique. Thus, the direct visualization technique is not necessarily required in a single-bundle AM portal ACL reconstruction using TightRope.

References

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Demographics and Operative Data of the Control and Visualization Groups

ParameterControl Group (N=32)Visualization Group (N=33)P
Age, mean±SD (range), y29.8±12.7 (14–55)25.7±9.6 (14–48).278
Male, No.20 (63%)32 (97%).001a
Body mass index, mean±SD (range), kg/m225.0±5.6 (16.8–42.9)23.5±3.6 (15.5–34.4).600
Graft size, mean±SD (range), mm7.8±0.8 (6–9)8.0±0.8 (7–10).487
Tourniquet time, mean±SD (range), min64.1±13.7 (49–95)69.6±13.2 (50–100).129
Meniscal injury, No.21 (66%)21 (64%)1.000

Radiographic Results of the Control and Visualization Groups Immediately Postoperative and 2 Years Postoperative

ParameterImmediately Postoperative2 Years Postoperative


Control Group (N=32)Visualization Group (N=33)PControl Group (N=32)Visualization Group (N=33)P
Cortical contact (0 to ≤1), No.18 (56%)18 (55%)1.00025 (78%)27 (82%).764
Gap distance, mean±SD (range), mm1.9±0.6 (1.1–3.1)1.8±0.4 (1.2–2.4).8271.5±0.2 (1.2–1.8)1.6±0.5 (1.2–2.4).945
  1< to ≤2, No.10 (71%)12 (80%)7 (100%)6 (100%)
  2< to <3, No.3 (22%)3 (20%)
  ≥3, No.1 (7%)0 (0%)

Knee Stability and Clinical Outcomes of the Control and Visualization Groups at 2 Years Postoperative

ParameterControl Group (N=32)Visualization Group (N=33)P
KT-1000 difference, mean±SD (range), mm1.3±0.9 (0–3)1.5±0.8 (0–4).404
  ≤1, No.16 (48%)19 (58%)
  1< to <3, No.15 (45%)12 (36%)
  ≥3, No.1 (3%)2 (6%)
Lysholm score, mean±SD (range)93.3±8.0 (64–100)91.6±9.0 (65–100).436
International Knee Documentation Committee score, mean±SD (range)82.5±12.5 (48.3–100)81.5±12.2 (52.9–100).507

Demographics and Clinical Outcomes at 2 Years Postoperative for the Contact and Non-contact Subgroups

CharacteristicContact Group (N=36)Non-contact Group (N=29)P
Age, mean±SD (range), y29.6±11.8 (15–55)25.4±10.5 (14–55).127
Male, No.30 (83%)22 (76%).540
Body mass index, mean±SD (range), kg/m224.4±4.5 (19.0–42.9)24.0±5.0 (15.5–39.1).663
Graft size, mean±SD (range), mm8.0±0.8 (6–10)7.9±0.8 (6–9).526
Meniscal injury, No.14 (39%)9 (31%).605
KT-1000 difference, mean±SD (range), mm1.4±0.8 (0–3)1.4±0.9 (0–4).837
Lysholm score, mean±SD (range)91.5±9.4 (64–100)94.3±7.0 (75–100).124
International Knee Documentation Committee score, mean±SD (range)80.0±11.9 (52.9–100)84.7±12.7 (48.3–98.9).129
Authors

The authors are from the Department of Orthopaedic Surgery (SS, IJK), Eunpyeong St Mary’s Hospital, and the Department of Orthopaedic Surgery (MSK, YI), Seoul St Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.

The authors have no relevant financial relationships to disclose.

Correspondence should be addressed to: Yong In, MD, PhD, Department of Orthopaedic Surgery, Seoul St Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul (06591), Republic of Korea ( iy1000@catholic.ac.kr).

Received: June 22, 2019
Accepted: March 31, 2020
Posted Online: August 06, 2020

10.3928/01477447-20200721-01

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