RetroBRACE: clinical, socioeconomic and functional-biomechanical outcomes 2 years after ACL repair and InternalBrace augmentation in comparison to ACL reconstruction and healthy controls-experimental protocol of a non-randomised single-centre comparative study

Sebastian Müller, Linda Bühl, Corina Nüesch, Geert Pagenstert, Annegret Mündermann, Christian Egloff, Sebastian Müller, Linda Bühl, Corina Nüesch, Geert Pagenstert, Annegret Mündermann, Christian Egloff

Abstract

Introduction: Despite good clinical outcomes reported in the literature, to date, scientific evidence for the functional and biomechanical benefit of primary anterior cruciate ligament (ACL) repair with augmentation is scarce. We present an experimental protocol for a detailed multimodal (clinical, socioeconomic, functional and biomechanical) comparative study in patients after primary ACL repair and InternalBrace augmentation, patients after ACL reconstruction and healthy controls.

Methods and analysis: In this non-randomised single-centre comparative study with prospective data collection with three arms (patients 2 years after ACL repair and InternalBrace augmentation; patients 2 years after ACL reconstruction using hamstring autografts; and healthy controls), 30 participants per study arm will be included. The study is designed as non-inferiority study with three arms. Required sample size was estimated based on data reported in the literature on muscle strength, proprioception and balance parameters, resulting in at least 28 participants per group. Outcome parameters include patient-reported outcome measures (EQ-5D-5L, Tegner Activity Scale, Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee and ACL-Return to Sports Injury Scale), socio-economic parameters, anterior tibial translation, range of motion and functional-biomechanical data of the lower extremities. Functional-biomechanical parameters include proprioception, isokinetic muscle strength, single-leg balance, walking, running and single-leg hops with additional lower extremity 3D joint kinematics and kinetics and muscle activity. These parameters will be compared between limbs in patients, between groups and to the current literature.

Ethics and dissemination: The results of this study will be disseminated through peer-reviewed publications and presentations at national and international conferences. Ethical approval was obtained by the regional ethics board (Ethics Committee Northwest Switzerland EKNZ 2020-00551), and the study is registered at clinicaltrials.gov.Trial registration numberNCT04429165.

Keywords: knee; orthopaedic & trauma surgery; orthopaedic sports trauma; surgery.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Schematic representation of ACL repair and InternalBrace augmentation (with kind permission from Arthrex). ACL, anterior cruciate ligament.
Figure 2
Figure 2
Electromyographic electrodes (red circles; electrodes on gluteus medius under the shorts) and marker placement for 3D motion analysis (black: anatomical marker; blue: thigh cluster marker; yellow: shank cluster marker) in ventral (A), sagittal (B) and dorsal (C) view.
Figure 3
Figure 3
Study protocol and clinical and functional-biomechanical assessments. All assessments will be made in a single session for each participant. ACL, anterior cruciate ligament; ACL-RSI, ACL-Return to Sports Injury Scale; EMG, electromyography; EQ-5D-5L, EuroQol Questionnaire; KOOS, Knee Injury and Osteoarthritis Outcome Score; IKDC, International Knee Documentation Committee; RoM, range of motion.

References

    1. Lohmander LS, Ostenberg A, Englund M, et al. . High prevalence of knee osteoarthritis, pain, and functional limitations in female soccer players twelve years after anterior cruciate ligament injury. Arthritis Rheum 2004;50:3145–52. 10.1002/art.20589
    1. Dare D, Rodeo S. Mechanisms of post-traumatic osteoarthritis after ACL injury. Curr Rheumatol Rep 2014;16:448. 10.1007/s11926-014-0448-1
    1. Khan T, Alvand A, Prieto-Alhambra D, et al. . Acl and meniscal injuries increase the risk of primary total knee replacement for osteoarthritis: a matched case-control study using the clinical practice research Datalink (CPRD). Br J Sports Med 2019;53:965–8. 10.1136/bjsports-2017-097762
    1. Chambat P, Guier C, Sonnery-Cottet B, et al. . The evolution of ACL reconstruction over the last fifty years. Int Orthop 2013;37:181–6. 10.1007/s00264-012-1759-3
    1. Vavken P, Proffen B, Peterson C, et al. . Effects of suture choice on biomechanics and physeal status after bioenhanced anterior cruciate ligament repair in skeletally immature patients: a large-animal study. Arthroscopy 2013;29:122–32. 10.1016/j.arthro.2012.07.006
    1. Wilson WT, Hopper GP, Byrne PA, et al. . Anterior cruciate ligament repair with internal brace ligament augmentation. Surg Technol Int 2016;29:273–8.
    1. Mackay GM, Blyth MJG, Anthony I, et al. . A review of ligament augmentation with the InternalBrace™: the surgical principle is described for the lateral ankle ligament and ACL repair in particular, and a comprehensive review of other surgical applications and techniques is presented. Surg Technol Int 2015;26:239–55.
    1. van der List JP, DiFelice GS. Preservation of the anterior cruciate ligament: a treatment algorithm based on tear location and tissue quality. Am J Orthop 2016;45:E393–405.
    1. Adachi N, Ochi M, Uchio Y, et al. . Mechanoreceptors in the anterior cruciate ligament contribute to the joint position sense. Acta Orthop Scand 2002;73:330–4. 10.1080/000164702320155356
    1. Yosmaoglu HB, Baltaci G, Kaya D, et al. . Tracking ability, motor coordination, and functional determinants after anterior cruciate ligament reconstruction. J Sport Rehabil 2011;20:207–18. 10.1123/jsr.20.2.207
    1. Cooper RL, Taylor NF, Feller JA. A randomised controlled trial of proprioceptive and balance training after surgical reconstruction of the anterior cruciate ligament. Res Sports Med 2005;13:217–30. 10.1080/15438620500222547
    1. Yosmaoğlu HB, Baltacı G, Kaya D, et al. . Comparison of functional outcomes of two anterior cruciate ligament reconstruction methods with hamstring tendon graft. Acta Orthop Traumatol Turc 2011;45:240–7. 10.3944/AOTT.2011.2402
    1. Moksnes H, Risberg MA. Performance-Based functional evaluation of non-operative and operative treatment after anterior cruciate ligament injury. Scand J Med Sci Sports 2009;19:345–55. 10.1111/j.1600-0838.2008.00816.x
    1. Pedersen M, Grindem H, Johnson JL, et al. . Clinical, functional, and physical activity outcomes 5 years following the treatment algorithm of the Delaware-Oslo ACL cohort study. J Bone Joint Surg Am 2021;103:1473–81. 10.2106/JBJS.20.01731
    1. Sonnery-Cottet B, Freychet B, Murphy CG, et al. . Anterior cruciate ligament reconstruction and preservation: the Single-Anteromedial bundle biological augmentation (SAMBBA) technique. Arthrosc Tech 2014;3:e689–93. 10.1016/j.eats.2014.08.007
    1. Jonkergouw A, van der List JP, DiFelice GS. Arthroscopic primary repair of proximal anterior cruciate ligament tears: outcomes of the first 56 consecutive patients and the role of additional internal bracing. Knee Surg Sports Traumatol Arthrosc 2019;27:21–8. 10.1007/s00167-018-5338-z
    1. Nakamura N, Horibe S, Sasaki S, et al. . Evaluation of active knee flexion and hamstring strength after anterior cruciate ligament reconstruction using hamstring tendons. Arthroscopy 2002;18:598–602. 10.1053/jars.2002.32868
    1. Gokeler A, Benjaminse A, Hewett TE, et al. . Proprioceptive deficits after ACL injury: are they clinically relevant? Br J Sports Med 2012;46:180–92. 10.1136/bjsm.2010.082578
    1. Kaur M, Ribeiro DC, Theis J-C, et al. . Movement patterns of the knee during gait following ACL reconstruction: a systematic review and meta-analysis. Sports Med 2016;46:1869–95. 10.1007/s40279-016-0510-4
    1. Pairot-de-Fontenay B, Willy RW, Elias ARC, et al. . Running biomechanics in individuals with anterior cruciate ligament reconstruction: a systematic review. Sports Med 2019;49:1411–24. 10.1007/s40279-019-01120-x
    1. Slone HS, Romine SE, Premkumar A, et al. . Quadriceps tendon autograft for anterior cruciate ligament reconstruction: a comprehensive review of current literature and systematic review of clinical results. Arthroscopy 2015;31:541–54. 10.1016/j.arthro.2014.11.010
    1. Johnston PT, McClelland JA, Webster KE. Lower limb biomechanics during Single-Leg Landings following anterior cruciate ligament reconstruction: a systematic review and meta-analysis. Sports Med 2018;48:2103–26. 10.1007/s40279-018-0942-0
    1. Kotsifaki A, Korakakis V, Whiteley R, et al. . Measuring only hop distance during single leg hop testing is insufficient to detect deficits in knee function after ACL reconstruction: a systematic review and meta-analysis. Br J Sports Med 2020;54:139–53. 10.1136/bjsports-2018-099918
    1. Schliemann B, Glasbrenner J, Rosenbaum D, et al. . Changes in gait pattern and early functional results after ACL repair are comparable to those of ACL reconstruction. Knee Surg Sports Traumatol Arthrosc 2018;26:374–80. 10.1007/s00167-017-4618-3
    1. Büchler L, Regli D, Evangelopoulos DS, et al. . Functional recovery following primary ACL repair with dynamic intraligamentary stabilization. Knee 2016;23:549–53. 10.1016/j.knee.2016.01.012
    1. Leister I, Kulnik ST, Kindermann H, et al. . Functional performance testing and return to sport criteria in patients after anterior cruciate ligament injury 12-18 months after index surgery: a cross-sectional observational study. Phys Ther Sport 2019;37:1–9. 10.1016/j.ptsp.2019.01.010
    1. Heusdens CHW, Blockhuys K, Roelant E, et al. . Suture tape augmentation ACL repair, stable knee, and favorable PROMs, but a re-rupture rate of 11% within 2 years. Knee Surg Sports Traumatol Arthrosc 2021;29:3706–14. 10.1007/s00167-020-06399-2
    1. Achtnich A, Herbst E, Forkel P, et al. . Acute proximal anterior cruciate ligament tears: outcomes after arthroscopic suture anchor repair versus anatomic Single-Bundle reconstruction. Arthroscopy 2016;32:2562–9. 10.1016/j.arthro.2016.04.031
    1. DiFelice GS, van der List JP. Clinical outcomes of arthroscopic primary repair of proximal anterior cruciate ligament tears are maintained at mid-term follow-up. Arthroscopy 2018;34:1085–93. 10.1016/j.arthro.2017.10.028
    1. van der List JP, Jonkergouw A, van Noort A, et al. . Identifying candidates for arthroscopic primary repair of the anterior cruciate ligament: a case-control study. Knee 2019;26:619–27. 10.1016/j.knee.2019.02.004
    1. van Eck CF, Limpisvasti O, ElAttrache NS. Is there a role for internal bracing and repair of the anterior cruciate ligament? A systematic literature review. Am J Sports Med 2018;46:2291–8. 10.1177/0363546517717956
    1. Hoogeslag RAG, Brouwer RW, de Vries AJ, et al. . Efficacy of Nonaugmented, static augmented, and dynamic augmented suture repair of the ruptured anterior cruciate ligament: a systematic review of the literature. Am J Sports Med 2020;48:3626–37. 10.1177/0363546520904690
    1. Akbari A, Ghiasi F, Mir M, et al. . The effects of balance training on static and dynamic postural stability indices after acute ACL reconstruction. Glob J Health Sci 2015;8:68–81. 10.5539/gjhs.v8n4p68
    1. Grindem H, Snyder-Mackler L, Moksnes H, et al. . Simple decision rules can reduce reinjury risk by 84% after ACL reconstruction: the Delaware-Oslo ACL cohort study. Br J Sports Med 2016;50:804–8. 10.1136/bjsports-2016-096031
    1. Janssen RPA, van der Wijk J, Fiedler A, et al. . Remodelling of human hamstring autografts after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc 2011;19:1299–306. 10.1007/s00167-011-1419-y
    1. Müller USM, Krüger-Franke M, et al. . ACL-return to sport after injury Skala ALS wichtiger parameter bei Der Beurteilung Rückkehr zum sport level 1 und level 2 nACh Rekonstruktion des vorderen Kreuzbandes (Deutsche version). Sportorthopädie-Sporttraumatologie 2014;2014:135.
    1. Irrgang JJ, Anderson AF, Boland AL, et al. . Development and validation of the International knee documentation Committee subjective knee form. Am J Sports Med 2001;29:600–13. 10.1177/03635465010290051301
    1. Roos EM, Roos HP, Lohmander LS, et al. . Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther 1998;28:88–96. 10.2519/jospt.1998.28.2.88
    1. Herdman M, Gudex C, Lloyd A, et al. . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20:1727–36. 10.1007/s11136-011-9903-x
    1. Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res 1985;198:43–9. 10.1097/00003086-198509000-00007
    1. Sherman MF, Lieber L, Bonamo JR, et al. . The long-term followup of primary anterior cruciate ligament repair. defining a rationale for augmentation. Am J Sports Med 1991;19:243–55. 10.1177/036354659101900307
    1. Pugh L, Mascarenhas R, Arneja S, et al. . Current concepts in instrumented knee-laxity testing. Am J Sports Med 2009;37:199–210. 10.1177/0363546508323746
    1. Ghasemi GA, Zolaktaf V, Ibrahim K. Evaluation of joint position sense after ACL reconstruction with hamstring tendon auto graft. American Journal of Sports Science and Medicine 2013;1:52–5.
    1. Ordway NR, Hand N, Briggs G, et al. . Reliability of knee and ankle strength measures in an older adult population. J Strength Cond Res 2006;20:82–7. 10.1519/R-16974.1
    1. Williams SB, Brand CA, Hill KD, et al. . Feasibility and outcomes of a home-based exercise program on improving balance and gait stability in women with lower-limb osteoarthritis or rheumatoid arthritis: a pilot study. Arch Phys Med Rehabil 2010;91:106–14. 10.1016/j.apmr.2009.08.150
    1. Schneiders A, Gregory K, Karas S, et al. . Effect of foot position on balance ability in single-leg stance with and without visual feedback. J Biomech 2016;49:1969–72. 10.1016/j.jbiomech.2016.04.020
    1. Gribble PA, Hertel J, Plisky P. Using the StAR excursion balance test to assess dynamic postural-control deficits and outcomes in lower extremity injury: a literature and systematic review. J Athl Train 2012;47:339–57. 10.4085/1062-6050-47.3.08
    1. Keller M, Kurz E, Schmidtlein O, et al. . [Interdisciplinary Assessment Criteria for Rehabilitation after Injuries of the Lower Extremity: A Function-Based Return to Activity Algorithm]. Sportverletz Sportschaden 2016;30:38–49. 10.1055/s-0042-100966
    1. Boyer KA, Andriacchi TP. The nature of age-related differences in knee function during walking: implication for the development of knee osteoarthritis. PLoS One 2016;11:e0167352. 10.1371/journal.pone.0167352
    1. Hafer JF, Kent JA, Boyer KA. Physical activity and age-related biomechanical risk factors for knee osteoarthritis. Gait Posture 2019;70:24–9. 10.1016/j.gaitpost.2019.02.008
    1. Alexander EJ, Andriacchi TP. Correcting for deformation in skin-based marker systems. J Biomech 2001;34:355–61. 10.1016/S0021-9290(00)00192-5
    1. Grood ES, Suntay WJ. A joint coordinate system for the clinical description of three-dimensional motions: application to the knee. J Biomech Eng 1983;105:136–44. 10.1115/1.3138397
    1. Kozanek M, Hosseini A, Liu F, et al. . Tibiofemoral kinematics and condylar motion during the stance phase of gait. J Biomech 2009;42:1877–84. 10.1016/j.jbiomech.2009.05.003
    1. Hermens HJ, Freriks B, Disselhorst-Klug C, et al. . Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol 2000;10:361–74. 10.1016/S1050-6411(00)00027-4
    1. Clark RA, Bell SW, Feller JA, et al. . Standing balance and inter-limb balance asymmetry at one year post primary anterior cruciate ligament reconstruction: sex differences in a cohort study of 414 patients. Gait Posture 2017;52:318–24. 10.1016/j.gaitpost.2016.12.016
    1. MKM AH, BULK M. Strength and proprioceptive difference between anterior cruciate ligament deficient and normal knee. Journal of Health and Translational Medicine 2017;20:1–5.
    1. Schmitt LC, Paterno MV, Hewett TE. The impact of quadriceps femoris strength asymmetry on functional performance at return to sport following anterior cruciate ligament reconstruction. J Orthop Sports Phys Ther 2012;42:750–9. 10.2519/jospt.2012.4194
    1. Streich NA, Zimmermann D, Bode G, et al. . Reconstructive versus non-reconstructive treatment of anterior cruciate ligament insufficiency. A retrospective matched-pair long-term follow-up. Int Orthop 2011;35:607–13. 10.1007/s00264-010-1174-6

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