Does Press-Fit Technique Reduce Tunnel Volume Enlargement After Anterior Cruciate Ligament Reconstruction With Autologous Hamstring Tendons? A Prospective Randomized Computed Tomography Study Dae-Hee Hwang, M.D., Gautam M. Shetty, M.S, Orth, Jong In Kim, M.D., Jae Ho Kwon, M.D., Jae-Kwang Song, M.D., Michael Muñoz, M.D., Jun Seop Lee, M.D., and Kyung-Wook Nha, M.D., Ph.D. Purpose: The purpose of this prospective, randomized, computed tomographyebased study was to investigate whether the press-fit technique reduces tunnel volume enlargement (TVE) and improves the clinical outcome after anterior cruciate ligament reconstruction at a minimum follow-up of 1 year compared with conventional technique. Methods: Sixty-nine patients undergoing primary ACL reconstruction using hamstring autografts were randomly allocated to either the press-fit technique group (group A) or conventional technique group (group B). All patients were evaluated for TVE and tunnel widening using computed tomography scanning, for functional outcome using International Knee Documentation Committee and Lysholm scores, for rotational stability using the pivot-shift test, and for anterior laxity using the KT-2000 arthrometer at a minimum of 1-year follow-up. Results: There were no significant differences in TVE between the 2 groups. In group A, in which the press-fit technique was used, mean volume enlargement in the femoral tunnel was 65% compared with 71.5% in group B (P ¼ .84). In group A, 57% (20 of 35) of patients developed femoral TVE compared with 67% (23 of 34) of patients in group B (P ¼ .27). Both groups showed no significant difference for functional outcome (mean Lysholm score P ¼ .73, International Knee Documentation Committee score P ¼ .15), or knee laxity (anterior P ¼ .78, rotational P ¼ .22) at a minimum follow-up of 1 year. Conclusions: In a comparison of press-fit and conventional techniques, there were no significant differences in TVE and clinical outcome at short-term follow-up. Level of Evidence: Level II, therapeutic study, prospective randomized clinical trial. T unnel widening (TW) after anterior cruciate ligament (ACL) reconstruction using hamstring tendon is a well-described phenomenon.1 TW has been reported to be more common with hamstring tendon autografts than with boneepatellar tendon autografts.2 From the Department of Orthopaedic Surgery (D-H.H., J.I.K., J.H.K., J-K.S., M.M., K-W.N.), Inje University, Ilsanpaik Hospital, Ilsan; Department of Orthopaedic Surgery (J.S.L.), Gumdan Top General Hospital, Incheon, Korea; and Department of Orthopaedic Surgery (G.M.S.), Breach Candy Hospital, Mumbai, India. Supported by a 2011 Inje University Research Grant. The authors report that they have no conflicts of interest in the authorship and publication of this article. Received November 24, 2011; accepted July 3, 2012. Address correspondence to Kyung-Wook Nha, M.D., PhD., Department of Orthopaedic Surgery, Inje University, Ilsanpaik Hospital, 2240 Daehwadong, Ilsanseogu, Goyangsi, Gyeonggido, 411-706, South Korea. E-mail: kwnhamj@hotmail.com Ó 2013 by the Arthroscopy Association of North America 0749-8063/11781/$36.00 http://dx.doi.org/10.1016/j.arthro.2012.07.007 This has been attributed to the longer time required for soft-tissueetoebone healing and the lesser stiffness of hamstring fixation techniques.3 Excessive TW after ACL reconstruction may jeopardize stability of graft fixation and compromise revision surgery because of poor bone stock, and sometimes a staged procedure is required.1 The causes of TW are unclear and are presumed to be multifactorial with mechanical and biological factors. Mechanical factors include excessive motion of graft that can result in a “bungee jump effect,” involving longitudinal motion of the graft, or “windshield-wiper effect,” involving transverse motion of the graft, tunnel positioning, and graft fixation method.1,3,4 Biological factors include access of joint fluid within the graftebone interface that contains osteolytic cytokines.5 Rigid initial graft fixation has been cited to be critical to the success of ACL reconstruction, and TW is more frequent when indirect fixation techniques such as the cortical button fixation are used compared with direct fixation methods such as double cross-pin or transfixation screw.1,6,7 Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol 29, No 1 (January), 2013: pp 83-88 83 84 D-H. HWANG ET AL. Despite proper fixation, bone TW has been observed following ACL reconstruction, especially when using soft-tissue grafts. Any gap between the graft and the tunnel wall can lead to ingress of synovial fluid and delay in tendon-to-bone healing and subsequently TW.8 A press-fit technique for hamstring tendon fixation might obviate the gap between the graft and tunnel wall and induce more rapid tendonebone consolidation by preventing ingress of joint fluids and maximizing the contact surface of the bone and tendon.8 However, there are few studies in the literature that have reported on tunnel volume enlargement (TVE) with the press-fit technique compared with the conventional technique. The timeline of TW has also been studied. Fink et al.9 noted that the greatest amount of widening occurs within the first 6 weeks. Webster et al.2 showed that the radiographic tunnel width did not significantly change between 4 months and 2 years. Therefore, the computed tomography (CT) examination in the current study was performed at 12 months after surgery. Hence, the purpose of this study was to investigate whether the press-fit technique reduces the TVE and improves the clinical outcome after ACL reconstruction at a minimum follow-up of 1 year compared with the conventional technique. We hypothesized that the press-fit technique would reduce the TVE and improve clinical scores compared with the conventional technique. Methods All patients who underwent arthroscopic primary ACL reconstruction using auto-hamstring tendon graft for an ACL rupture at a single institution between October 2007 and January 2009 were eligible for enrollment in this prospective randomized study. The inclusion criteria were a unilateral isolated ACL rupture, age 18 to 40 years, a normal contralateral knee, and informed consent by the patient for participation in the study. Patients with an associated meniscal injury were also included in the study. There were 27 meniscal injuries in group A (press-fit technique) and 28 meniscal injuries in group B (conventional technique). The exclusion criteria were concomitant ligament injury, cartilage degeneration greater than Outerbridge grade 2 on arthroscopic assessment, ACL reconstruction using an allograft, and a follow-up of less than 1 year postoperatively. The study was approved by the institutional review board of the hospital. A total of 85 patients underwent the procedure during the study period, and 79 of the 85 patients agreed to participate in the study. Based on the exclusion criteria, 4 patients with an associated ligament injury and 3 patients with cartilage degeneration greater than grade 2 were excluded from the study. Finally, 72 patients were enrolled in the study, in which the patients were randomly allotted to a press-fit technique group or a conventional technique group based on a random number table. Three patients were lost to follow-up for reasons not known, and the final analysis involved data from 35 patients (35 knees) in the press-fit technique group (group A) and 34 patients (34 knees) in the conventional technique group (group B). The surgical procedure was performed on all patients in both groups by a single senior surgeon (K.W.N.), and the same postoperative rehabilitation protocol was followed. After ACL reconstruction, all patients underwent CT scanning to determine femoral TW at 1 week postoperatively and at a minimum of 1-year postoperative follow-up. There were 31 male patients and 4 female patients in group A with a mean age of 28.5 years (range, 19 to 40 years) who were followed for a mean period of 13.5 months (range, 12 to 17 months), and group B had 27 male patients and 7 female patients with a mean age of 27.4 years (range, 18 to 40 years) who were followed for a mean period of 14.5 months (range, 12 to 18 months). Surgical Technique In all cases, the semitendinosus and gracilis tendons, which had been harvested using a tendon striper, were prepared as a 4-stranded double-looped hamstring autograft. The ACL tibial guide (Linvatec, Largo, FL) was set to 45 to prepare the tibial tunnel. The femoral tunnel was drilled using the transtibial technique. Tunnel diameter was determined according to the harvested tendon diameter, which varied from 7 to 8 mm. For the femoral tunnel, a 5.5-mm offset drill guide was placed on the posterior aspect of the notch, which had been positioned as determined with the transtibial guide at approximately 10:30 o’clock orientation for the right knee or at approximately 1:30 o’clock orientation for the left knee and drilled to a depth of 30 mm. In group A (press-fit technique group), tunnel preparation was performed by underdrilling by 0.5 mm after measuring the diameter of the prepared auto-hamstring tendon graft to achieve press-fit of the graft in both the tibial and femoral tunnel. In group B (conventional technique group), tunnel preparation was performed using the same-sized drill after measuring the diameter of the prepared graft to allow easy passage of the graft in both tunnels. The fixation technique for the femoral and the tibial side was the same in both groups. After passing the graft through the femoral tunnel, it was secured using the RigidFix system (DePuy Mitek, Raynham, MA). Once the graft had been secured on the femoral side, the knee was positioned in 10 flexion and both loops were placed on the IntraFix tie tensioner (DePuy Mitek) with 25-lb force. The tibial end of the graft was then fixed using an IntraFix biodegradable screw (DePuy Mitek) supplemented by a screw and spiked washer. Postoperative Rehabilitation Patients in both groups followed an identical accelerated postoperative rehabilitation regimen. Closed PRESS-FIT TECHNIQUE AFTER ACL RECONSTRUCTION Fig 1. The method of measurement of tunnel volumes in the axial CT scan. chain kinetic exercises were started on the third postoperative day. Full weight bearing was allowed 7 days after surgery. Partial weight bearing with crutches for 6 weeks was mandated for patients who also underwent a concomitant meniscal repair. The goal for the patients was to gain a full range of motion at 2 to 6 weeks after surgery. A perturbation training program was started at 6 weeks after surgery. Running and side-cutting activities were allowed at 3 months, with a return to sports activities at 6 months after surgery. CT Evaluation A noncontrast CT scan of the operated knee in the supine position was performed using a spiral CT scan system (Somatom Emotion 6; Siemens GmbH, Berlin, Germany). The CT images were acquired at 120 kV and 75 mA, with a slice thickness of 2 mm with a 0.5-mm collimation. Scans were performed at 1 week and a minimum follow-up of 1 year postoperatively. The volume and diameter were measured by 2 orthopaedic surgeons blinded to the groups to which the patients were allotted. To measure the tunnel volume, a series of CT cross-sectional images were obtained for each femur condyle. The femoral tunnel was identified at the axial viewing image. Using a digitized picture archiving and communication system (STARPACS; Infinite Healthcare, Seoul, South Korea), we estimated the cross-sectional area of each tunnel in each image (Fig 1). The cross-sectional area on each picture was totaled and multiplied to calculate the total volume for the femoral tunnels. The volume of the tunnel was calculated using the formula pr2h. TVE was classified into 2 categories based on the presence or absence of enlargement. Tunnel enlargement was present if the 85 TVE was 65% or greater and was absent if it was less than 65%. As per this classification, an increase in 65% of the volume in a tunnel that was reamed to 7 mm indicates a 2-mm increase in its diameter. On the CT scans, femoral tunnels were divided into 3 assessment zones: zone I, which made up one-third of the tunnel closest to the joint; zone II, which made up the middle third of each tunnel; and zone III, which made up the outermost third of the tunnel with respect to the joint. Tunnel width was measured as the distance between the widest marginal rim of each zone of the femoral and tibial tunnel on both the coronal and sagittal sections of CT scan using STARPACS. TVE was defined as an increase in volume of greater than 65% when femoral tunnel volume measured at a minimal 1-year follow-up was compared with the baseline volume measured at 1 week postoperatively (Fig 2). The tunnel volume measured at 1 week postoperatively was used as the baseline measurement, which was compared with the volume measured at a minimum of 1-year follow-up postoperatively. The intraobserver and interobserver agreements, for tunnel diameter measurements as assessed with use of the k coefficient, were excellent in every case (0.92 [95% confidence interval (CI), 0.9 to 0.94] and 0.9 [95% CI, 0.89 to 0.91], respectively). Clinical Assessment All patients were assessed for function using the International Knee Documentation Committee (IKDC) and Lysholm scores both preoperatively (on admission) and postoperatively (at 1 week and minimum 1-year follow-up). Similarly, anterior knee laxity was quantitatively measured both preoperatively and postoperatively using the KT-2000 arthrometer (MEDmetric, San Diego, CA) with a standard manual force of 134 N and 3 mm of side-to-side difference as the cut-off point. The rotational stability was confirmed by the pivot-shift test. Statistical Analysis A power analysis was performed before commencing the study to determine the sample size. In a pilot study of 10 cases, femoral tunnel width was 9.9 1.3 mm, 9.1 1.2 mm at 1 year follow-up and 1 week postoperatively. For a power set at .8 and the a value at .05, the sample size required was 34 patients in each group. The current study, with 35 patients in group A and 34 patients in group B, had a power of .81. The presence or absence of tunnel enlargement (i.e., enlargement of >65% or 65%) in the 2 groups was compared using the c-square test for independence. Independent-samples t-test was used to compare the amount of tunnel volume increase at 1 week and minimum 1-year follow-up within the 2 groups. Clinical scores of patients between preoperative and postoperative evaluations were compared with use of the Mann-Whitney U test. Statistical analysis was performed 86 D-H. HWANG ET AL. Fig 2. CT scans in sagittal plane after 1-year follow-up showing (A) femoral tunnel enlargement in group A (press-fit technique group) and (B) femoral tunnel enlargement in group B (conventional technique group). using the SPSS 18.0 (SPSS, Chicago, IL) software, and P < .05 was considered to be significant. Results There was no significant difference between the 2 groups for mean age at the time of operation (P ¼ .47), mean follow-up period (P ¼ .24), and sex ratio (P ¼ .46). CT Measurements The initial CT mean tunnel volume was 1,386 86 mm2 in group A and 1,325 99 mm2 in group B. In group A (press-fit technique), the increment of the mean femoral tunnel volume was 65%, and it was 71.5% in group B at 1-year follow-up. There was no statistical difference for mean TVE in the femur between the 2 groups (P ¼ .84). The number of cases with an increase in femoral tunnel volume in group A (20/35 cases, or 57%) was not significantly different from the number of cases in group B (23/34 cases, or 67%) that showed femoral tunnel enlargement (Table 1). Table 1. TVE of the Femoral Tunnel at Minimum Follow-up of 1 Year in Both Groups Volume increase Yes (>65%) No (65%) Mean volume increasing (%) Mean volume Group A (n ¼ 35) Press-Fit Technique Group B (n ¼ 34) Conventional Technique P (<.05) 20 15 64.9 23 11 71.5 .27 .27 .33 2,309 588 2,272 723 .84 Clinical Results The median Lysholm score in group A increased from 63 (range, 59 to 68) preoperatively to 94 (range, 61 to 100) at last follow-up, which was not significantly different from group B, in which the mean preoperative score of 59 (range, 36 to 71) increased to the median score of 92.5 (range, 52 to 100) postoperatively (P ¼ .73). Preoperative IKDC scores were abnormal in 21 patients and severely abnormal in 14 patients in group A and abnormal in 22 patients and severely abnormal in 12 patients in group B. This improved to normal in 16 patients and nearly normal in 19 patients in group A and normal in 12 patients, nearly normal in 20 patients, and abnormal in 2 patients in group B. There was no significant differences in IKDC scores between the 2 groups (P ¼ .15). On KT-2000, 32 patients in group A had less than 3 mm of side-to-side difference (average 1.5 1.3 mm), and in group B, 31 patients had less than 3 mm (average, 1.8 1.5 mm) difference. In group A, there were 3 cases of grade 1 pivot-shift test. There were 4 cases of grade 1 pivot-shift test in group B. No significant difference for pivot-shift test and anterior laxity as measured on KT-2000 was found between the 2 groups (P ¼ .78 and .22). Discussion We hypothesized that the press-fit technique might reduce the volume increase in femoral tunnel and improve clinical scores by reducing synovial fluid ingress within the bone tunnel. However, the results of our CT-based study did not show any significant difference in TVE when the press-fit technique was compared with the conventional technique during PRESS-FIT TECHNIQUE AFTER ACL RECONSTRUCTION primary ACL reconstruction with hamstring autograft at a minimum postoperative follow-up of 1 year. Few studies have compared the incidence of TW in groups where different fixation methods have been used during ACL reconstruction. In a prospective comparison of EndoButton (Smith & Nephew Endoscopy, Andover, MA) versus double cross-pins for femoral fixation, Baumfeld et al.10 reported significantly greater femoral TW with the EndoButton fixation method on knee radiographs. However, Klein et al.11 reported that significant TW occurs with quadrupled hamstring autografts using femoral crosspin fixation. Hence, although the double cross-pin method carries less risk of femoral TW than the suspensory fixation method in ACL reconstruction, the double cross-pin fixation method still carries a significant risk of TW. In the current study, although cross-pin fixation was supplemented with the press-fit technique during ACL reconstruction with auto hamstring tendons, we could not find any significant reduction in TVE in the femur. The results of our study showed no significant difference between the 2 techniques in terms of functional scores or rotation and anterior knee laxity when assessed clinically at a minimum postoperative followup of 1 year. This finding is similar to that reported by other studies that have compared the clinical outcome of TW in 2 groups where 2 different femoral fixation techniques were used in ACL reconstruction.10,12 Despite reporting significant increase in widening in one fixation group compared with the other, these studies showed no significant difference in the clinical outcome between the groups in the short term.10,12 The extent of widening and zone of involvement in the femoral tunnel may vary based on the type of fixation used. In their CT evaluation of 34 patients with ACL reconstruction with hamstring graft, Sabat et al.12 reported that femoral TW was highest at aperture, medium at midway, and least at proximal and that tunnel and femoral TW was significantly lesser in the EndoButton group compared with the TransFix (Arthrex, Naples, FL) group. In the current study, femoral TW was greater compared with tibial TW in both groups where a RigidFix fixation method was used on the femur. In comparisons of each zone of this study, however, the zone of involvement was significantly greater in zone II (mid-zone) compared with zone I (aperture) in group A and the widening was in the form of a cavity. The zone of involvement was similar in both zone I (aperture) and zone II (mid-zone) and the widening was cylindrical in group B. This finding implies that the press-fit technique used in group A resulted in less TW at the tunnel aperture compared with the mid-zone. This could be the result of a lesser amount of a synovial fluid entering the tunnel due to the presence of a snugly fitting graft in group A. 87 Previous reports have described other techniques of tunnel preparation such as impaction drilling,13 drilling and dilatation,14 and press-fit bone plug fixation without hardware to improve fixation minimize TW; only one study actually analyzed the effect of such techniques on TW. Jagodzinski et al.,15 in a CT-based study, reported significantly less widening of the proximal tibial tunnel with press-fit bone plug fixation after ACL reconstruction at short-term follow-up. Although their study did not analyze femoral tunnels, the findings concerning tibial TW were similar to those of our study. However, the modification in operative technique of underdrilling used in the present study is much simpler and less technically challenging compared with the other techniques described. In this prospective, randomized study, we sought to keep the 2 study groups as similar to each other as possible by using the same surgeon, fixation method, and postoperative rehabilitation regimen. However, there are a few limitations to this study. First, this study has a short-term follow-up for CT scan analysis and evaluation of clinical outcome in the patients. Although there was no significant difference in change in tunnel volume and clinical outcome between the 2 techniques in the current study, it is possible that this may become evident if these patients are followed for longer durations. Second, the time period when CT analysis was done postoperatively could also be an important factor that can influence the result of the study. Fink et al.9 noted that the greatest amount of widening occurs within the first 6 weeks, whereas Webster et al.2 showed that the radiographic tunnel width did not significantly change between 4 months and 2 years. The time point for the CT evaluation was 12 months in our study. This could have influenced the results of our study. Third, tunnel enlargement based on the type of fixation method used was not part of the study. Fourth, clinical outcome based on other activity scores, Tegner score, or pivot shift was not used in this study. Finally, the changes in incidence and extent of tunnel enlargement over mid- and long-term follow-up are not known and were not part of this study. Conclusions Between the press-fit and conventional techniques, there were no significant differences in TVE and clinical outcome at short-term follow-up. References 1. Fauno P, Kaalund S. Tunnel widening after hamstring anterior cruciate ligament reconstruction is influenced by the type of graft fixation used: A prospective randomized study. Arthroscopy 2005;21:1337-1341. 2. Webster KE, Feller JA, Hameister KA. Bone tunnel enlargement following anterior cruciate ligament reconstruction: A randomized comparison of hamstring and 88 3. 4. 5. 6. 7. 8. 9. D-H. HWANG ET AL. patellar tendon grafts with 2-year follow-up. Knee Surg Sports Traumatol Arthrosc 2001;9:86-91. Höher J, Möller HD, Fu FH. Bone tunnel enlargement after anterior cruciate ligament reconstruction: Fact or fiction? Knee Surg Sports Traumatol Arthrosc 1998;6:231-240. 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Anterior cruciate ligament reconstruction using semitendinosus and gracilis tendons, bone patellar tendon, or quadriceps tendon-graft with press-fit fixation without hardware: A new and innovative procedure. Orthop Clin North Am 2003;34:49-64. Fink C, Zapp M, Benedetto KP, Hackl W, Hoser C, Rieger M. Tibial tunnel enlargement following anterior 10. 11. 12. 13. 14. 15. cruciate ligament reconstruction with patellar tendon autograft. Arthroscopy 2001;17:138-143. Baumfeld JA, Diduch DR, Rubino LJ, et al. Tunnel widening following anterior cruciate ligament reconstruction using hamstring autograft: A comparison between double cross-pin and suspensory graft fixation. Knee Surg Sports Traumatol Arthrosc 2008;16: 1108-1113. Klein JP, Lintner DM, Downs D, Vavrenka K. The incidence and significance of femoral tunnel widening after quadrupled hamstring anterior cruciate ligament reconstruction using femoral cross-pin fixation. Arthroscopy 2003;19:470-476. Sabat D, Kundu K, Arora S, Kumar V. Tunnel widening after anterior cruciate ligament reconstruction: A prospective randomized computed tomographyebased study comparing 2 different femoral fixation methods for hamstring graft. Arthroscopy 2011;27:776-783. Siebold R, Kiss ZS, Morris HG. Effect of compaction drilling during ACL reconstruction with hamstrings on postoperative tunnel widening. Arch Orthop Trauma Surg 2008;128:461-468. Dargel J, Schmidt-Wiethoff R, Brüggemann GP, Koebke J. The effect of bone tunnel dilation versus extraction drilling on the initial fixation strength of press-fit anterior cruciate ligament reconstruction. Arch Orthop Trauma Surg 2007;127:801-807. Jagodzinski M, Geiges B, von Falck C, Knobloch K, Haasper C, Brand J, Hankemeier S. Biodegradable screw versus a press-fit bone plug fixation for hamstring anterior cruciate ligament reconstruction: A prospective randomized study. Am J Sports Med 2010;38:501-508.