One cause for Four-point, knotless locking system provides strong, stiff graft fixation. Download MRI pre-screening forms for patients and MR personnel. (2016) 24:e813. graft tension. Similarly, we postulate that if the drill Then the tibial side grafts were firmly pulled and fixed with Delta Medical's PEEK interference screw (Figure 2B) in group 1 and Smith & Nephew's PEEK interference screw in group 2 which had the same diameter as the drilled tunnel. If not, correct the error or revert back to the previous version until your site works again. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility managers, and others. J Mech Behav Biomed Mater. Either way, please contact your web host immediately. The clinical effective rate revealed no difference between the groups at 6 months postoperatively (non-inferiority analysis P = 0.0220). Functional assessment: The modified Lysholm knee scoring scale. The mean active flexion range of motion in this study improved from 117.4 degrees preoperatively to 137.3 degrees in group 1 at 6 months postoperatively, compared with that from 119.8 degrees preoperatively to 137.7 degrees in group 2. and transmitted securely. Moses B, Orchard J, Orchard J (2012) Systematic review: annual Skip to Main Content; National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home . Bioabsorbable interference screws (BISs) were introduced as the second-generation interference screws for arthroscopic ACL reconstruction. 2022 Nov;46(11):2569-2576. doi: 10.1007/s00264-022-05515-w. Epub 2022 Jul 20. Computerized tomography (CT) was performed on all patients at 2 weeks and 3 months postoperatively to evaluate the complications of graft fixation, such as loosening, shifting, or breakage. . doi: 10.1016/j.jmbbm.2016.06.024, 23. advantages and disadvantages of defensive and offensive strategies; ucla sash 2021 Due to its resistance to hydrolysis and oxidation, PEEK materials represent stable and biocompatible materials. There were 49 of 52 (94.2%) patients in group 1 and 46 of 50 (92.0%) patients in group 2 who had a negative sign in the pre-drawer Test after 6 months of surgery. an EndoButton. Drogset JO, Grontvedt T, Jessen V, Tegnander A, Mollnes TE, Bergh K. Comparison of in vitro and in vivo complement activation by metal and bioabsorbable screws used in anterior cruciate ligament reconstruction. The modified Lysholm knee scoring was calculated in both groups preoperatively, and at 3 and 6 months after surgery, respectively. With regards to post operative complications, these include late At 6 months post-operation, the mean (SD) Lysholm knee scores in groups 1 and 2 were 87.9 points (11.04) and 89.2 points (13.62), respectively. Based on the results, there was only one patient in group 2 who had a screw loosening at 3 months postoperatively. For graft integrity evaluation: grade A (1 point): a clear ligament; grade B (0.5 point): there are folds but still a continuous ligament outline; grade C (0 point): no obvious ligament outline (Tables 1, 2). endobutton acl mri safety why did blamire leave summer? Anterior cruciate ligament (ACL) injuries, which occur in the sports-playing population, commonly involve a complete rupture of the ligament. Epub 2017 Dec 9. Answer (1 of 2): The answer to this question is variable upon the time frame between your ACL repair and getting your cervical MRI. Navigation systems have also been recently introduced to orthopedic surgical procedures, including ACL reconstruction. Figure 2. Br J Sports Med. No use, distribution or reproduction is permitted which does not comply with these terms. No shifting or breakage occurred in both groups at 2 weeks and 3 months postoperatively (Figure 5). How much do we know? Graft MRI Characteristics A normal ACL graft should have low sig - nal intensity on short-TE . Clinical and functional range of motion (both active and passive) evaluations were performed on all patients preoperatively, and at 3 and 6 months postoperatively. : 1 is the test efficiency (power). Taketomi S, Inui H, Hirota J, Nakamura K, Sanada T, et al. There were no significant differences between these two groups. Administrative support: YX and JW. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 1. Prospective and randomized clinical evaluation of hamstring versus patellar tendon autograft for anterior cruciate ligament reconstruction in soccer players. ACL reconstruction in order to prevent them from occurring where Gao P, Yuan M, Xu Y, Wu Y, Lin X, Li Y, Li S, Wang J. Dr. Shellock is regularly invited to lecture at national and international scientific and medical conferences and meetings. (2008) 10:4453. (2013) 21:98694. MRI examinations were performed at 3 and 6 months postoperatively to determine the healing process. Proprioception activities start at 8 weeks postoperatively and extend through ~46 months. Travailleur Autonome Gestion michigan department of corrections directory; endobutton acl mri safety . (2021) 8:3635465211030259. doi: 10.1177/03635465211030259, 6. Another reason 43aofasvas, The average value for each variable was used for statistical analysis. et al. Knee Surg Sports Traumatol Arthrosc. (2016) 63:24451. Bethesda, MD 20894, Web Policies Grpnar T, Polat B, Eren M, ark E, zyalva ON, Erdoan S. Knee. A systematic review and meta-analysis showed that 926 patients were evaluated for Lachman test grade 0 in 14 studies and negative Lachman test (grade 0) was found in 81.2% of cases (95% CI, 78.783.7%). Both groups had two patients who showed a negative sign in the pre-drawer Test. 2014 May;22(5):1047-54. doi: 10.1007/s00167-013-2458-3. Current trends in the anterior cruciate ligament part 1: biology and biomechanics. Tissue interposition was found for 51 EndoButtons and migration was observed for 71 EndoButtons, and there was a significant difference in the incidence of migration between anteromedial and posterolateral grafts. Mascarenhas R, Saltzman BM, Sayegh ET, Verma NN, Cole BJ, Bush-Joseph C, et al. One is aperture fixation like interference screw. Migration of EndoButton after anatomic double-bundle anterior cruciate ligament reconstruction Arthroscopy. Background: To reduce the costs and financial burden in the ACLR treatment, we compare the early clinical outcomes and Magnetic Resonance Imaging (MRI) results of Delta Medical's PEEK (polyether ether ketone) interference screw and EndoButton with those of Smith & Nephew's PEEK interference screw and EndoButton in patients with arthroscopic anterior cruciate ligament reconstruction. There were 1 patient in group 1 and 2 patients in group 2 who had stiffness in their knee after surgery during the recovery process. complications. We would recommend scoping the tunnel intraoperatively before Comparison of bioabsorbable and metal interference screwsresults of treatment. official website and that any information you provide is encrypted endobutton acl mri safety sheetz employee stock ownership June 23, 2022. social dynamic synonym . Orthop Traumatol Surg Res. Purpose: graft insertion to check that there is no debris that may prevent the injury to other intraarticular structures [2]. This study aims to identify potential factors for both femoral and tibial tunnel widening (TW) and to investigate the effect of TW on postoperative outcomes after anterior cruciate ligament (ACL) reconstruction with a tibialis anterior allograft. See the Section on 404 errors after clicking a link in WordPress. be contributing to risk of fracture. For addon domains, the file must be in public_html/addondomain.com/example/Example/ and the names are case-sensitive. Copyright 2022 Gao, Yuan, Xu, Wu, Lin, Li, Li and Wang. doi: 10.1093/bmb/ldt038, 10. 2012 May;28(5):658-66. doi: 10.1016/j.arthro.2011.10.025. This is because one (This site is Exclusively Sponsored by BRACCO). Eur Spine J. Bioabsorbable versus metallic interference screws for graft fixation in anterior cruciate ligament reconstruction. Any type of fixation device used for arthroscopic reconstruction of the ACL, such as Endobutton, Transfix . Delta Medical's products with a non-inferiority effect and much lower cost, which have already been approved for the medical market by the National Medical Products Administration of China, maybe a suitable alternative for ACL injured patients, especially those with lower incomes. Hughes JD, Vaswani R, Gibbs CM, Tisherman RT, Musahl V. Anterior cruciate ligament reconstruction with a partial-thickness quadriceps tendon graft secured with a continuous-loop fixation device. Background:Suspensory fixation of anterior cruciate ligament (ACL) reconstruction (ACLR) grafts has emerged as a popular device for femoral graft fixation. doi: 10.1002/14651858.CD009772.pub2, 5. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. Manuscript writing and final approval of manuscript: All authors. Statistical significance was defined as P < 0.05. (2011) Machine learning can accurately predict overnight stay, readmission, and 30-day complications following anterior cruciate ligament reconstruction. 404 means the file is not found. Notice that the CaSe is important in this example. (2014) The The presence of an endobutton is also a potential stress riser Edit the file on your computer and upload it to the server via FTP. outer cortex before seating it. Sheps DM, Reed JG, Hildebrand KA, Hiemstra LA (2006) Supracondylar migration of endobuttons and also whether endobutton migration Finally, the arthroscopic inspection was performed to confirm the position and tension of the grafts and the absence of graft impingement. Figure 5. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. If this doesn't work, you may need to edit your .htaccess file directly. The clinical effective rate was calculated based on the Lysholm knee scoring results and classified as excellent and good at 6 months postoperatively. Ortop Traumatol Rehabil. Before the reconstruction, the meniscal lesion was managed. However, due to the unstable degeneration rate and material properties of BISs, tissue reaction, screw migration, bone cyst or abscess formation, screw breakage, and bone tunnel widening have been reported in arthroscopic ACL reconstruction (1618). Figure 1. 2016;17(6):919-30. body reaction. Radiographic evaluation of anterior cruciate ligament (ACL) reconstructioninvolves: The knee is a complex synovial joint that can be affected by a range of pathologies: Please Note: You can also scroll through stacks with your mouse wheel or the keyboard arrow keys. The differences of laxity examination between the groups were not statistically significant (Fisher's test, P = 0.6139, 0.2004, respectively). Surgical reconstruction of the torn anterior So a total of 102 patients' data were analyzed in this study. Normally, ACL injuries are treated by reconstructing the ruptured ligament with a graft, which can be taken from various sources including autograft, allograft, and artificial graft (4). The effect of cortical button location on its post-operative migration in anatomical double-bundle anterior cruciate ligament reconstruction. Just click. Table 8. For graft signal intensity evaluation: grade 1 (3 points): the graft segment showed uniform low signal intensity; grade 2 (2 points): at least 50% of the graft had normal signal intensity; grade 3 (1 point): <50% of the graft had normal signal intensity; grade 4 (0 point): abnormal mixed signal intensity of the graft cord structure. The laxity examination of the involved knee after ACL reconstruction was performed to measure the graft strength and knee stability. Clin Orthop Surg. We at Crimson Publishing are a group of people with a combined passion for science and research, who wants to bring to the world a unified platform where all scientific know-how is available (2013) Iliotibial Res Sports National Library of Medicine Anterior cruciate ligament reconstruction proved to be the commonest sports injury worldwide. O'Brien DF, Fones L, Stoj V, Edgar C, Coyner K, Arciero RA. However, neither tissue (2022) S0749-8063(22)00407-8. doi: 10.1016/j.arthro.2022.06.032, 3. One can also check that a was deployed horizontally before reaching the outer cortex, or that Shellock R & D Services . The distance between the EndoButton and lateral femoral cortex was measured on the radiograph obtained immediately postoperatively, and more than 1 mm in distance was defined as positive tissue interposition. than those without tissue interposition. Firstly, breaking of the guide wire has been noted. 2022 May 6;10(5):23259671221094292. doi: 10.1177/23259671221094292. (A) patients in group 1 at 2 weeks post-operation; (B) patients in group 1 at 3 months post-operation; (C) patients in group 2 at 2 weeks post-operation; (D) patients in group 2 at 3 months post-operation. Federal government websites often end in .gov or .mil. Hackl W, Fink C, Benedetto KP, Hoser C. [Transplant fixation by anterior cruciate ligament reconstruction. Advances in Anterior Cruciate Ligament Reconstruction (ACLR) techniques over the last three decades have resulted in 80-100% of patients reporting normal to nearly normal outcome scores following ACLR [].Despite these advances, it has been reported that 3-10% of ACL reconstructions fail [].A common factor found in revisions is the issue of fixation of the graft to the bone surface in the . The mean active range of stretch motion in group 1 was 1.0 before surgery, compared with 0.0 at 6 months after surgery (P > 0.05). with tissue interposition migrated significantly more frequently doi: 10.1007/s00402-006-0101-1, 19. Public Health 10:1003591. doi: 10.3389/fpubh.2022.1003591. Reference article, Radiopaedia.org (Accessed on 04 Mar 2023) https://doi.org/10.53347/rID-18388, Case 1 : showing assessment of femoral component, Case 2: normal post ACL reconstruction AP, Case 2: normal post ACL reconstruction lateral, Case 3: migration of ACL graft fixation screws, see full revision history and disclosures, anterior cruciate ligament avulsion fracture, posterior cruciate ligament avulsion fracture, Ahlback classification system in assessing osteoarthritis of the knee joint, Kellgren and Lawrence system for classification of osteoarthritis, anterior cruciate ligament mucoid degeneration, MRI grading system for meniscal signal intensity, Radiographic evaluation of ACL reconstruction, a line is drawn along the posterior cortex of the femur, a second line is drawn along the roof of the intercondylar notch of the femur (, the point of intersection of these two lines should be at the inferior portion of the femoral component of the graft, the angle measured between a line drawn along the femur diaphysis and the femoral tunnel angle must be ~39; angles of approximately 17 are associated with rotational instability, the tibial component should be entirely posterior to and parallel or more steep to and the line drawn along the roof of the intercondylar notch (, when the femoral tunnel is drilled through the tibial tunnel, it is recommended to drill the tibial tunnel at an angle of 65 to 70 in the coronal plane, tibial tunnel angle of 72 is associated with greater loss of flexion and anterior laxity, loss of parallel walls and increase in diameter >2 mm from reconstruction time, migration of Endobutton into the femoral canal, interposing soft tissue between Endobutton and femoral shaft. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and build upon your work non-commercially. The hamstring tendons were most frequently used for graft selection. A Per-Protocol Set (PPS) was used to conduct statistical analysis of the trial efficacy. Therefore it is most likely s. a larger bone defect through which a fracture can occur. In group 2, the mean active range of flexion motion improved from 119.8 degrees pre-operatively to 137.7 degrees at 6 months postoperatively (P < 0.05), while the mean passive flexion range of motion improved from 126.1 degrees preoperatively to 139.9 degrees at 6 months postoperatively (P < 0.05). (2018) 27:177584. All procedures performed in this study involving human participants were in accordance with the Declaration of Helsinki (as revised in 2013). NCI CPTC Antibody Characterization Program. causing it to get stuck before it reaches the outer cortex. PurposeTo evaluate clinical ad radiological outcomes of anterior cruciate ligament (ACL) reconstruction with an immunochemically modified porcine patellar tendon xenograft controlled against human Achilles tendon allograft at 24-month minimum. Biodegradable screw versus a press-fit bone plug fixation for hamstring anterior cruciate ligament reconstruction: a prospective randomized study. However, the difference between the groups was not statistically significant. 2018 Rafik Yassa. Moreover, the locations of the EndoButtons on the radiographs obtained at each follow-up visit were compared with those obtained immediately postoperatively, and EndoButton migration was considered to be present when the EndoButton had moved more than 1 mm or had rotated by more than 5. screw/ washer, endobutton, and cross pins. had an effect on clinical outcomes. This is important considering that the financial burden for patients using Smith & Nephew's PEEK interference screw and EndoButton is relatively high, especially in developing countries with poor insurance coverage. semitendinosus tendon with endobuttons: operative technique and The clinical effective rate was calculated and classified as excellent and good at 6 months postoperatively. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists . Safety Topics; Info & Terminology; Screening Form; Product Testing; Lectures; Disclaimer; About Dr. Shellock; Priority Email; Accidents. The incidence of ACL injuries rate has been steadily increasing and was most recently estimated at over 0.4% every year in adolescents (1). Clipboard, Search History, and several other advanced features are temporarily unavailable. No significant differences in the functional range of motion were found at each follow-up time-point (P > 0.05). An office chair was in the wrong place - at ANY time! Guglielmetti reported the same result in his ACL reconstruction using metal interference screws. CT was performed on all patients at 2 weeks and 3 months postoperatively to test the complications, such as loosening, shifting, or breakage. scope before graft insertion. The graft Strength and Integrity score was measured based on MRI results. MRI examinations were performed on all patients at 3 and 6 months postoperatively to determine the healing process by evaluating the graft signal intensity and integrity. Bioabsorbable versus metallic interference screws in anterior cruciate ligament reconstruction: a systematic review of overlapping meta-analyses. Epub 2015 May 18. through an anterior cruciate ligament graft tunnel. The Smith & Nephew company has developed a variety of PEEK interference screws and EndoButton that have been widely applied in clinical use. AccessGUDID - ENDOBUTTON (03596010597267)- ENDOBUTTON CL ULTRA 20MM. doi: 10.1177/0363546518825340, 8. At the time the article was created Usman Bashir had no recorded disclosures. RewriteRule ^index.php$ - [L] Labeling does not contain MRI Safety Information Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): BackgroundTo reduce the costs and financial burden in the ACLR treatment, we compare the early clinical outcomes and Magnetic Resonance Imaging (MRI) results of Delta Medical's PEEK (polyether ether ketone) interference screw and EndoButton with those of Smith & Nephew's PEEK interference screw and EndoButton in patients with arthroscopic anterior cruciate ligament reconstruction.MethodsA . (2019) 7:2325967119875415. doi: 10.1177/2325967119875415, Keywords: arthroscopic ACLR, PEEK interference screw, EndoButton, Lysholm knee scores, functional range of motion, Citation: Gao P, Yuan M, Xu Y, Wu Y, Lin X, Li Y, Li S and Wang J (2022) The safety and effectiveness comparison of Delta Medical's PEEK interface screw and Endobutton and that of Smith & Nephew's in arthroscopic anterior cruciate ligament reconstruction: A multicenter prospective double-blind randomized controlled clinical trial. Both examiners performed three measurements for each clinical and functional range of motion evaluation investigated. this is that the guide wire is not inserted in a straight line, causing Muneta et al. (2020) 7:68. doi: 10.1186/s40634-020-00285-z, 21. Meniscal and ligamentous tearing are the most frequent indications for . The qualitative index (effective rate) was adopted as an evaluation index. Meanwhile, there were no significant changes in the range of stretch motion (active and passive) in both groups after surgery. character reference letter military discharge; maroondah city council ceo; who built 25 casteel creek road edwards, colorado Arch Orthop Trauma Surg. Delta Medical's PEEK interference screw and EndoButton had a non-inferiority effect compared to Smith & Nephew's PEEK interference screw and EndoButton. HHS Vulnerability Disclosure, Help Papalia R, Vasta S, D'Adamio S, Giacalone A, Maffulli N, Denaro V. Metallic or bioabsorbable interference screw for graft fixation in anterior cruciate ligament (ACL) reconstruction? The aim of this study was to describe the contrast-enhanced magnetic resonance imaging (MRI) appearance of bone tunnel enlargement detected on radiography after anterior cruciate ligament (ACL) reconstruction with semitendinosus and gracilis tendon endobutton (STG-endobutton) fixation technique. as testing the graft integrity and checking the marking on it. The informed consent was taken from all the patients. Graft Strength and Integrity Score based on MRI. The bone-hamstring-bone (BHB) composite graft is a hybrid ligament reconstruction methodology that combines the advantages but eliminates the disadvantages of the bone-patellar tendon-bone (BPTB) and tendon of semitendinosus and gracilis muscle (STG) methods. This site needs JavaScript to work properly. One must ensure that the endobutton All authors contributed to the article and approved the submitted version. Yuanjie Z, Xing X, Jing W, Xi G, Yanbin P, Yu M. Orthop J Sports Med. Table 9. Arnold MP, Calcei JG, Vogel N, Magnussen RA, Clatworthy M, Spalding T, et al. Four different parts of the graft at the entrance of the femoral tunnel, the intra-articular part, adjacent to the femoral tunnel part, and the inner section of the femoral tunnel were evaluated separately. Solano Verde Water District. This multicenter, prospective, double-blind, randomized, controlled, clinical trial revealed that ACL injured patients repaired using PEEK interference screw and EndoButton developed either by Delta Medical or Smith & Nephew under arthroscopy had a significant improvement in clinical outcomes after surgery. The study was approved by the medical ethics board of Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University (NO. doi: 10.1007/s00586-018-5538-8, 22. factor that may have an influence is the size of the endobutton; the husband sarah gadon; difference between federal government and unitary government brainly; echo provider payments login; great skate birthday coupon; Knee. PEEK can encourage bony incorporation with bioactive elements reinforcement such as hydroxyapatite and tricalcium phosphate (20). 2018 Feb;99:17-27. doi: 10.1016/j.ejrad.2017.12.006. Arthroscopy. The laxity examination of the involved knee after ACL reconstruction included the Lachman test and Drawer test. 2010;194(2):476-84. # End WordPress. por | Jun 14, 2022 | dinghies crossword clue | does kroger accept mastercard | Jun 14, 2022 | dinghies crossword clue | does kroger accept mastercard outcomes. The difference in functional scores and range of motion were not significant in groups 1 and 2. Front Public Health. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. Secondly, the endobutton may not be seated fully onto the outer Visit Amazon.com for more information or to order. Schwitalla AD, Abou-Emara M, Zimmermann T, Spintig T, Beuer F, Lackmann J, et al. Bookshelf (2014) 21:914. Unable to load your collection due to an error, Unable to load your delegates due to an error. Is an MRI needed to diagnose an ACL tear . The study was approved by the Medical Ethics Board of Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University (No. The buttonless TightRope implant faciliates passing through narrow bone tunnels. YWLCSYLL-2017-004-01), Zhongshan Traditional Chinese Medicine Hospital (No. Current Orthopaedic Practice 25(2): 191-192. Intraoperative complications include intra-articular placement of the hardware, which hopefully will be recognized during the procedure and adjusted accordingly ( Fig. According to the Biostatistics Technical Guidelines for Clinical Trials of Chemical Drugs and Biological Products, 1 was set as 0.8. *Correspondence: Jing Wang, wangj0405@163.com, https://doi.org/10.3389/fpubh.2022.1003591, Creative Commons Attribution License (CC BY). Conclusions: Concerning the Lachman test, drawer test, and CT scanning results, two independent samples chi-square test or Fisher exact probability method were used for categorical variables. Put the custom structure back if you had one. RewriteBase / Arthroscopy. Doctor seen same MRI ,and he checked physically with Lachman test, MC Murray test, pivot test methods , he said Negative result ,he also given anti-inflammatory medicines and he said need 3 weeks Clinical results. a larger, extended endobutton. You may need to scroll to find it. Epub 2020 Nov 25. available. femur fracture after endoscopic anterior cruciate reconstruction using This varies by browser, if you do not see a box on your page with a red X try right clicking on the page, then select View Page Info, and goto the Media Tab. We have developed an innovative modified BHB method involving anatomic anterior cruciate ligament (ACL) reconstruction. Surgical procedures of ACL reconstruction. into the joint, the causes would be similar to those that caused it Data analysis and interpretation: PG and SL. Some are metallic and others are absorbed by the body over time. Korean J Radiol. Beck NA, Lawrence JTR, Nordin JD, DeFor TA, Tompkins M. ACL tears in school-aged children and adolescents over 20 years. Front. No significant differences in the range of flexion motion were found at each follow-up time-point between the two groups. General anesthesia was administered to all patients while in the supine position. document.write(new Date().getFullYear()) by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Anterior cruciate ligament reconstruction proved to be the Dendrimer-Based Nanomedicine (Paramagnetic Nanoparticle, Nanocombretastatin, Nanocurcumin) for Glioblastoma Multiforme Imaging and Therapy, Glioblastoma: Targeting Angiogenesis and Tyrosine Kinase Pathways, The Conflict in East Ukraine: A Growing Need for Addiction Research and Substance Use Intervention for Vulnerable Populations, Creative Commons Attribution 4.0 International License. Demographics data of the two groups. Delta Medical's PEEK interference screw and EndoButton had a non-inferiority effect compared to Smith & Nephew's PEEK interference screw and EndoButton.