The Knee 21 (2014) 1018–1022 Contents lists available at ScienceDirect The Knee Radiodense ligament markers for radiographic evaluation of anterior cruciate ligament reconstruction Paul Borbas ⁎, Karl Wieser, Stefan Rahm, Sandro F. Fucentese, Peter P. Koch, Dominik C. Meyer Balgrist University Hospital, Orthopaedic Department, Zurich, Switzerland a r t i c l e i n f o Article history: Received 5 January 2014 Received in revised form 2 May 2014 Accepted 5 July 2014 Keywords: ACL rerupture Graft failure Soft tissue marker ACL reconstruction a b s t r a c t Introduction: Early clinical and radiographic diagnosis of failed or loosened anterior cruciate ligament (ACL) reconstructions can be challenging. The aim of the present study is to retrospectively evaluate the use of radiologically visible markers in the ACL graft, serving as a potential diagnostic tool in ACL graft rupture and insufficiency. Methods: Twenty patients were included in the study. ACL reconstruction was performed with use of a hamstring autograft in hybrid fixation technique. The graft was marked with two radiodense suture knots, one at the tibial and femoral tunnel openings. Radiographs were performed postoperatively, after 6 weeks and 12 months. Four distances between markers and landmarks were measured in anteroposterior and three in lateral radiographic views and the positional change between the timepoints of measurement was calculated. Results: Measurements of the marker distances on radiographs showed an excellent interobserver reliability (κ = 0.97). In two measured distal anteroposterior distances statistically significant changes could be detected between 6 weeks and 12 months postoperatively in one patient with MRI-documented ACL rerupture and in five patients with ACL elongation defined as anteroposterior-translation with side-to-side difference of ≥3 mm measured with a Rolimeter device. On lateral radiographs, marker distances were highly variable and did not correlate with clinical ACL elongation. Conclusion: The application of radiodense ACL graft markers is a straight-forward, non-expensive and potentially useful diagnostic tool to identify the position of the transplant and for diagnosis of graft elongation or failure. However, the method is sensitive to the radiological projection, which should be further studied and optimized. © 2014 Elsevier B.V. All rights reserved. 1. Introduction The anterior cruciate ligament (ACL) is the second most commonly injured knee ligament and its reconstruction is among the most frequently performed orthopaedic operations [1]. The success rate of ACL reconstruction varies from 69% to 95%. However, clinical diagnosis of reruptures can be difficult due to swelling, joint effusion and pain, especially in the early postoperative or posttraumatic period. Commonly, standard anteroposterior (ap) and lateral knee radiographs are performed in patients after knee trauma and after ACL reconstruction. However, although the proper positioning of the bone tunnels and fixation material may well be evaluated, the integrity of the ACL auto- or allograft cannot. Therefore the migration of radiodense markers that are securely fixed within the graft material might be helpful in diagnosing elongation or rerupture and, thus, insufficiency of the reconstructed ACL. Several studies have addressed soft tissue markers in order to measure ACL graft lengthening or rotator cuff reconstruction failure [2–7]. ⁎ Corresponding author at: Forchstrasse 340, 8008 Zurich, Switzerland. Tel.: +41 44 386 1111; fax: +41 44 386 1109. E-mail address: paul.borbas@balgrist.ch (P. Borbas). http://dx.doi.org/10.1016/j.knee.2014.07.003 0968-0160/© 2014 Elsevier B.V. All rights reserved. All of these in vivo or in vitro studies used radiostereometric analysis (RSA) to study relative motion in three dimensions. RSA is a well established technique for monitoring migration of prostheses relative to bone and also to detect soft tissue marker migration. However, practical use of RSA remains limited because the sophisticated radiological systems required are not commonly available in a routine practice. To the authors' knowledge, no prior study evaluated the use of intraligamentary ACL graft marking with standard radiographs in two planes without RSA. We hypothesized that due to the well-defined direction of the graft however the use of plain radiographs may be feasible with appropriate markers and measurement technique. The aim of the present study was therefore to evaluate the use of radiodense ACL graft marking by measuring postoperative marker migration over time and consequently, to establish a new diagnostic tool for ACL graft rupture or insufficiency. 2. Materials and methods Between September and December 2010 in 27 patients an ACL reconstruction was performed using a hamstring autograft marked with radiodense sutures. Eight patients had an additional meniscal procedure during surgery, either partial meniscectomy or meniscal repair. All P. Borbas et al. / The Knee 21 (2014) 1018–1022 1019 surgical procedures were performed by the same two experienced orthopaedic surgeons. All patients received on a regular basis clinical follow-ups after six weeks, three, six and finally 12 months after ACL reconstruction. Standardized anteroposterior (ap) (with an extended knee) and lateral (with 30° flexion) radiographs were performed postoperatively, after six weeks and 12 months. At 12-month follow-up measurement of anteroposterior translation in 30° knee flexion by using a Rolimeter (Aircast Europe, Neubeuern, Germany) device and clinical examination with IKDC (International Knee documentation committee) score was performed. 2.1. Surgical technique The pes anserinus was visualized through a three centimeter incision anteromedially at the proximal tibia. The semitendinosus tendon was harvested with a tendon stripper and the length and thickness were measured. If the length or diameter of the quadrupled semitendinosus graft was not sufficient, gracilis tendon was harvested as well and the graft consisted of doubled gracilis and doubled semitendinosus tendon. Afterwards the grafts were prepared using a nonabsorbable braided suture to hold both ends using baseball stitches (FiberWire, Arthrex, Naples, FL, USA). Finally, two intra-ligamentary metallic suture knots (stainless steel monofilament, USP No. 4–0, Ethicon Inc., Somerville, NJ, USA), grasping approximately one to two millimeters of tendon tissue were placed in the approximate center of the graft. The positions were chosen such that the markers would be at or close to the tibial and femoral openings of the bone tunnels, resulting in a distance of about two centimeters between the knots. Standard medial and lateral parapatellar arthroscopy portals were used. The femoral tunnel was drilled first via the anteromedial portal. A guide wire was placed with a guide system (Karl Storz, Tuttlingen, Germany) at the femoral footprint of the ACL in the intercondylar notch in a knee flexion of at least 100°. After overdrilling with a 4.5 mm drill, the final femoral graft tunnel was created by a cannulated drill with a diameter according to the prepared graft. Afterwards the tibial tunnel was prepared by using a drillguide (Karl Storz, Tuttlingen, Germany) targeted at the center of the tibial ACL footprint. Femoral fixation was achieved using a flipping device on the cortical bone (Fliptack, Karl Storz, Tuttlingen, Germany), combined with a resorbable interference screw compressing a bone wedge to the transplant (Megafix, Karl Storz, Tuttlingen, Germany). In the tibial tunnel the graft was secured with an interference screw (Megafix, Karl Storz, Tuttlingen, Germany) with the knee close to full extension. Additionally, the sutures of the tibial graft side were again fixed on cortical bone using a small plate (Endotack, Karl Storz, Tuttlingen, Germany) covering the bone tunnel. Mobilisation was started the day after surgery with flexion limit of 120° and extension limit of 0° for six weeks. After six weeks free range of motion was allowed. Weight bearing was limited to half body weight on crutches in an extension brace for three weeks. Running was permitted after three months, high-demand pivoting sport was allowed after a minimum of six months postoperatively. 2.2. Marker distances and measurements Seven radiographic marker distances were measured at three times (postoperatively, after 6 weeks and after 12 months) by two independent observers. Of these, four marker distances were determined in ap- (named “A1”–“A4”) and three marker distances were determined in lateral X-rays (named “L1”–“L3”) (Fig. 1 a and b). Changes of marker distances over time were calculated for all seven distances and for all different time-points and named as ΔAa/ΔLa for the difference from postoperative to 6 weeks and as ΔAb/ΔLb for the difference from 6 weeks to 12 months. Changes were detected in proximal or distal directions and calculated as positive values no matter if the distances increased or decreased (Fig. 2). Fig. 1. a: Anteroposterior (ap) X-ray with four ap marker distances: A1: proximal fixation– proximal marker; A2: proximal marker–distal marker; A3: distal marker–distal fixation; A4: intercondylar eminence–distal marker. The center of the proximal fixation (Fliptack, Karl Storz, Tuttlingen, Germany) and distal fixation (Endotack, Karl Storz, Tuttlingen, Germany) device was used for measurements. b: Lateral X-ray with three lateral marker distances: L1: proximal fixation–proximal marker; L2: proximal marker–distal marker; and L3: distal marker–distal fixation. 2.3. Statistical analysis Statistical analysis was performed using IBM SPSS® statistics software (version 20.0, Chicago, Illinois) by an independent biostatistician. Interclass observer correlation between two independent observers was measured. The intraclass correlation coefficient (κ) can have a value between 0 (no agreement) and 1 (absolute agreement) and was classified according to Fleiss as excellent if larger than 0.75. One-way paired Student t test was performed to analyse differences of marker distances between the time periods. Sub-groups of patients with aptranslation side–side difference of less than three millimeters and patients with side–side difference of minimum three millimeters were built. Unpaired Student t test was performed to examine the data. pValues ≤ 0.05 were deemed to be statistically significant. Furthermore a Pearson correlation analysis was performed to examine the association between clinical changes of ap-translation and radiological distance changes. 3. Results Of the 27 operated patients four emigrated within 12 months after surgery. Three patients did not show up for 12 months follow-up evaluation. One of them could not be traced and two refused a followup visit, despite a favourable clinical outcome as verified by telephone interview. All of these patients had to be excluded leading to a study group of twenty patients. However, three of them had history of an ACL reconstruction on the contralateral knee and were therefore excluded from the statistical analysis concerning side-to-side differences. In one case the distal marker dislocated out of the ACL graft. Therefore only the A1 distance could be calculated in this case. 1020 P. Borbas et al. / The Knee 21 (2014) 1018–1022 Fig. 2. Enlarged X-ray demonstrating a steel suture used as intra-ligamentary ACL graft marker. The crossing points (marked with a cross) were used for measurements of marker distances. The measurements of the marker distances on X-rays showed an excellent interobserver reliability (κ = 0.97). Of the remaining 17 patients, eleven (65%) had side-to-side differences of less than three millimeters in ap translation and were defined as “normal ACL”. Six patients (35%) with a side-to-side difference of three millimeters or more than three millimeters in ap-translation were defined as patients with “ACL elongation/insufficiency”. One of those six patients had an ACL re-rupture confirmed on MRI after a knee distortion during football and finally underwent ACL re-reconstruction using a bone–patella–bone autograft. However, the other five patients are having slight or no complaints and are willing to proceed with conservative treatment. Characteristics and differences between the groups are depicted in Table 1. Additional procedures included partial meniscectomy or meniscal suture (n = eight) as well as open-wedge high tibial osteotomy (n = three) for correction of a varus angulated knee with signs of medial osteoarthritis. In five patients the procedure was a revision ACL reconstruction. As expected, increased ap-translation side–side difference of at least three millimeters was more likely in patients who underwent high tibial osteotomy for valgisation and in patients who underwent ACL revision (re-reconstruction) because of failed ACL reconstruction in the past. In the subgroup with “ACL elongation/insufficiency” ΔA3b (p = 0.007) and ΔA4b (p = 0.004) were significantly higher than in the control group without clinical signs of ACL insufficiency (Fig. 3a,b). Similar changes could be seen as well on lateral radiographs. However, those changes were not as clear and did not reach statistical significance. At a ΔA4b cut off value of five millimeters a sensitivity of 100% and specificity of 72% was reached for detecting side-to-side difference of three millimeters or more than three millimeters in ap-translation. The highest correlation was detected for ΔA4b (r = 0.47) and ΔA3b (r = 0.41). 4. Discussion To objectively evaluate whether a reconstructed cruciate ligament is intact, elongated or ruptured can be very challenging both clinically and radiologically. Conventional radiographs are routinely performed after ACL reconstructions, however the reconstructed ligaments are not radiodense and thus invisible on radiographs. It appears therefore attractive to mark the transplants with a radiodense suture marker in order to see positional changes of the ligament relative to bone on conventional radiographs, without the need for further sophisticated radiological tools or methods. We were able to confirm our hypothesis, that the application of radiodense ACL graft markers has the potential to visualize the position of the graft on conventional radiographs. We could detect a significant correlation of clinical insufficiency and change of two measured parameters, from the distal marker to the distal fixation device (A3) and from the intercondylar eminence to the distal marker (A4) between six weeks and 12 months postoperatively. In three of seven patients with clinical signs of ACL insufficiency the A3 and A4 distances increased, whereas in four patients those distances decreased. These results indicate that ACL graft elongation may occur both proximal and distal to the opening of the tibial canal. This is in certain contrast to the report of Van Eck et al., showing that autografts tended to rupture or elongate mainly proximally [8]. We have to state that in our data only one MRI-documented ACL rerupture occurred (Fig. 4). In this case the failure area was mid-substance with distal movement of the marker. ACL graft markers have been used in vivo before, however in combination with RSA. Tantalum markers were inserted as beads into the femur, the tibia and the graft for detection of three dimensional micromotions [5], however with documented micromotion of the beads within the graft. Roos et al. first used stainless steel sutures in ACL graft marking, but only as cages for tantalum balls that were used as RSA markers [7]. Cashman et al. finally used stainless steel sutures as RSA markers in an in vitro study [4]. They showed that stainless steel sutures were not as exact as tantalum beads when used as RSA markers, but were still accurate within approximately 1 mm. The same research group further published an in vivo study where they used stainless steel sutures as soft tissue markers in reconstructed rotator cuff tendons for monitoring the behaviour of rotator cuff after repair with RSA [3]. Even though RSA appears to be a very reliable experimental tool, due to the technical difficulties the application of RSA in a routine clinical practice to detect ACL graft rupture or insufficiency appears not to be a realistic scenario. This is to our best knowledge the first study that evaluates the use of radiodense ACL graft marking with standard X-rays in two planes and correlates these results with the clinical patients' outcome. We are aware of the limitations of this preliminary report. The number of patients is limited and not fully homogeneous, as there were additionally performed procedures such as high tibial osteotomy and there were a considerable number of patients lost to follow-up. However, with the available numbers and data, the technical aspects regarding the radiological projection are already well visible and additional surgical procedures should not have relevantly influenced this analysis. Furthermore, due to the retrospective nature of the study there is no control group with markers in intact ligaments. The implantation of the radiodense markers was as expected a quick and simple surgical step, which did Table 1 Illustration of patients and results of two groups divided by ap-translation side–side difference: The terms ΔA3b and ΔA4b are demonstrating the change of the measured distances between distal X-ray marker and distal fixation device (A3) and between intercondylar eminence and distal X-ray marker (A4) from 6 weeks to 12 months postoperatively on ap radiographs. Number (m:f) Age (in years) Mean side–side difference of ap-translation Additional meniscal procedures Additional valgisation osteotomy Revision ACL reconstruction Mean IKDC Mean ΔA3b Mean ΔA4b ap-translation side–side difference b 3 mm ap-translation side–side difference ≥ 3 mm p 11 (9:2) 30 (20–48) 1.5 mm 5 (45%) 1 (9%) 2 (18%) Normal–nearly normal 3,6 mm 3,8 mm 6 (4:2) 36 (18–55) 4.3 mm 3 (50%) 2 (33%) 3 (50%) Nearly normal–abnormal 9.9 mm 10.4 mm 0.007 0.004 P. Borbas et al. / The Knee 21 (2014) 1018–1022 1021 Figs. 3. a, b: Illustrations of the statistically significant distance differences measured between distal X-ray marker and distal fixation device (A3) and between intercondylar eminence and distal X-ray marker (A4) from 6 weeks to 12 months postoperatively on ap radiographs. not increase surgical time in our hands. As a technical problem however, in one patient an obvious distal marker dislocation was radiologically detected, but without clinical instability and with no detectable associated clinical or radiological disadvantage. Although we found encouraging results when analysing ap radiographs, in lateral radiographic measurements there was a large variation of the marker positions and a poor correlation with clinical ACL lengthening. This effect was most pronounced in the images performed immediately postoperatively without the use of fluoroscopy and is most likely due to angular variations in the radiographic projection. The nature of this effect and how to address it will therefore further be analysed in an on-going research project. From the current data we conclude so far, that strictly standardized radiographs are a prerequisite for reliable results. 5. Conclusion The application of radiodense ACL graft markers seems to be a straight-forward, non-expensive and potentially useful diagnostic tool to identify the position of the transplant and for diagnosis of ACL graft elongation and insufficiency. However, there is still room for improvement of the optimal technique for reproducible radiologic 1022 P. Borbas et al. / The Knee 21 (2014) 1018–1022 imaging and therefore further gain of the diagnostic value of this method. Conflict of interest The authors declare that they have no conflict of interest. References [1] Oh YH, Namkoong S, Strauss EJ, Ishak C, Hecker AT, Jazrawi LM, et al. Hybrid femoral fixation of soft-tissue grafts in anterior cruciate ligament reconstruction using the EndoButton CL and bioabsorbable interference screws: a biomechanical study. Arthrosc 2006;22–11:1218–24. [2] Ashmore AM, Rout R, Beard DJ, Price AJ, Murray DW, Gill HS. A new technique for the radiostereometric analysis of soft tissues. J Biomech 2012;45–16:2931–4. [3] Baring TK, Cashman PP, Reilly P, Emery RJ, Amis AA. Rotator cuff repair failure in vivo: a radiostereometric measurement study. J Shoulder Elbow Surg 2011;20–8:1194–9. [4] Cashman PM, Baring T, Reilly P, Emery RJ, Amis AA. Measurement of migration of soft tissue by modified Roentgen stereophotogrammetric analysis (RSA): validation of a new technique to monitor rotator cuff tears. J Med Eng Technol 2010;34–3:159–65. [5] Khan R, Konyves A, Rama KR, Thomas R, Amis AA. RSA can measure ACL graft stretching and migration: development of a new method. Clin Orthop Relat Res 2006;448:139–45. [6] Roos PJ, Hull ML, Howell SM. Lengthening of double-looped tendon graft constructs in three regions after cyclic loading: a study using Roentgen stereophotogrammetric analysis. J Orthop Res 2004;22–4:839–46. [7] Roos PJ, Hull ML, Howell SM. How cyclic loading affects the migration of radio-opaque markers attached to tendon grafts using a new method: a study using roentgen stereophotogrammetric analysis (RSA). J Biomech Eng 2004;126–1:62–9. [8] van Eck CF, Kropf EJ, Romanowski JR, Lesniak BP, Tranovich MJ, van Dijk CN, et al. Factors that influence the intra-articular rupture pattern of the ACL graft following single-bundle reconstruction. Knee Surg Sports Traumatol Arthrosc 2011;19–8:1243–8. Fig. 4. ap radiograph of a patient 6 weeks (left image) and 12 months (right image) postoperatively. The patient had a MRI-documented ACL rerupture after a knee distortion during football.