Nonoperative, open reduction and internal fixation or primary arthrodesis in the treatment of Lisfranc injuries: a prospective, randomized, multicenter trial - study protocol

Ville T Ponkilainen, Ville M Mattila, Heikki-Jussi Laine, Antti Paakkala, Heikki M Mäenpää, Heidi H Haapasalo, Ville T Ponkilainen, Ville M Mattila, Heikki-Jussi Laine, Antti Paakkala, Heikki M Mäenpää, Heidi H Haapasalo

Abstract

Background: Lisfranc injuries are known to be rare and often overlooked injuries that can cause long-term disability and pain when missed or treated incorrectly. The wide variety of Lisfranc injuries ranges from subtle ligament distensions to open fracture dislocations. The treatment of Lisfranc joint injuries is still controversial and very little is known about what types of injury can be treated nonoperatively. The current literature provides only two randomized studies on dislocated Lisfranc injuries. These studies have shown that primary arthrodesis (PA) leads to a similar or better outcome and results in fewer secondary operations when compared with open reduction and internal fixation (ORIF) in ligamentous injuries. There have been no previous randomized studies of the nonoperative versus operative treatment of Lisfranc injuries. Therefore, the purpose of this study is to compare the operative and nonoperative treatment of non-dislocated Lisfranc injuries and to compare the ORIF and PA treatment of dislocated Lisfranc injuries.

Methods: This study is a prospective, randomized, national multi-center trial. The trial comprises two strata: Stratum I compares cast-immobilization versus open reduction and internal fixation (ORIF) treatment of non-dislocated Lisfranc joint injuries. Stratum II compares PA versus ORIF in the treatment of dislocated injuries of the Lisfranc joint. The main hypothesis of stratum I is that the nonoperative treatment of non-dislocated Lisfranc injuries achieves a similar outcome compared with operative treatment (ORIF). The hypothesis of stratum II is that PA of dislocated Lisfranc injuries yields a similar functional outcome compared with ORIF, but that PA results in fewer secondary operations than ORIF. The main outcome measure is the American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot score and the secondary outcome measures are Visual-Analogue-Scale Foot and Ankle (VAS-FA), Visual-Analogue-Scale (VAS), rate of secondary operations and other treatment-related complications. The results will be analyzed after the 2-year follow-up period.

Discussion: This publication presents a prospective, randomized, national multi-center trial study protocol. It provides details of patient flow, randomization, aftercare and methods of analysis of the material and ways to present and publish the results.

Trial registration: ClinicalTrials.gov identifier: NCT02953067 24.10.2016.

Keywords: Arthrodesis; Conservative treatment; Lisfranc; ORIF; Operative treatment.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Regional Ethics Committee of Tampere University Hospital in November 2011. All participants will provide a written consent to participate.

Consent for publication

Not applicable.

Competing interests

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organization for the submitted work; HH has been paid for educational presentations and travel expenses by DePuySynthes and Stryker. The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow diagram
Fig. 2
Fig. 2
Intraoperative view of the screw and K-wire fixation of the TMT joints

References

    1. Lau S, Bozin M, Thillainadesan T. Lisfranc fracture dislocation: a review of a commonly missed injury of the midfoot. Emerg Med J. 2016;0:1–6.
    1. Wolf JH. François Chopart (1743–1795) — inventor of the partial foot amputation at the tarsometatarsal articulation. Orthop Traumatol. 2000;8(4):314–317.
    1. Aitken AP, Poulson D. Dislocations of the tarsometatarsal joint. J Bone Joint Surg (Am Vol) 1963;45-A:246–260. doi: 10.2106/00004623-196345020-00003.
    1. English TA. Dislocations of the metatarsal bone and adjacent toe. J Bone Joint Surg. 1964;46:700–704. doi: 10.1302/0301-620X.46B4.700.
    1. Myerson MS, Fisher RT, Burgess AR, Kenzora JE. Fracture dislocations of the tarsometatarsal joints: end results correlated with pathology and treatment. Foot Ankle. 1986;6(5):225–242. doi: 10.1177/107110078600600504.
    1. Vuori JP, Aro HT. Lisfranc joint injuries: trauma mechanisms and associated injuries. J Trauma. 1993;35(1):40–45. doi: 10.1097/00005373-199307000-00007.
    1. Haapamaki VV, Kiuru MJ, Koskinen SK. Ankle and foot injuries: analysis of MDCT findings. AJR Am J Roentgenol. 2004;183(3):615–622. doi: 10.2214/ajr.183.3.1830615.
    1. Desmond EA, Chou LB. Current concepts review: Lisfranc injuries. Foot Ankle Int. 2006;27(8):653–660. doi: 10.1177/107110070602700819.
    1. Myerson MS. The diagnosis and treatment of injury to the tarsometatarsal joint complex. J Bone Joint Surg. 1999;81-B(5):756–763. doi: 10.1302/0301-620X.81B5.0810756.
    1. Turco VJ. Diastasis of first and second tarsometatarsal rays: a cause of pain in the foot. Bull N Y Acad Med. 1972;49(3):222–225.
    1. Myerson MS, Cerrato RA. Current management of tarsometatarsal injuries in the athlete. J Bone Joint Surg (Am Vol) 2008;90(11):2522–2533.
    1. Hardcastle PH, Reschauer R, Kutscha-Lissberg E, Schoffmann W. Injuries to the tarsometatarsal joint. Incidence, classification and treatment. J Bone Joint Surg (Am Vol) 1982;64(3):349–356. doi: 10.1302/0301-620X.64B3.7096403.
    1. Kuo RS, Tejwani NC, Digiovanni CW, Holt SK, Benirschke SK, Hansen ST, Jr, Sangeorzan BJ. Outcome after open reduction and internal fixation of Lisfranc joint injuries. J Bone Joint Surg (Am Vol) 2000;82-A(11):1609–1618. doi: 10.2106/00004623-200011000-00015.
    1. Mann RAMD, Prieskorn DDO, Sobel MMDSLC. Mid-tarsal and Tarsometatarsal arthrodesis for primary degenerative osteoarthrosis or osteoarthrosis after trauma*. J Bone Joint Surg (Am Vol) 1996;78(9):1376–1385. doi: 10.2106/00004623-199609000-00013.
    1. Sangeorzan BJ, Veith RG, Hansen ST., Jr Salvage of Lisfranc’s tarsometatarsal joint by arthrodesis. Foot Ankle. 1990;10(4):193–200. doi: 10.1177/107110079001000401.
    1. Johnson JE, Johnson KA. Dowel arthrodesis for degenerative arthritis of the tarsometatarsal (Lisfranc) joints. Foot Ankle. 1986;6(5):243–253. doi: 10.1177/107110078600600505.
    1. Main BJ, Jowett RL. Injuries of the midtarsal joint. J Bone Joint Surg Br. 1975;57(1):89–97. doi: 10.1302/0301-620X.57B1.89.
    1. Thompson MC, Mormino MA. Injury to the tarsometatarsal joint complex. J Am Acad Orthop Surg. 2003;11(4):260–267. doi: 10.5435/00124635-200307000-00005.
    1. Stavlas P, Roberts CS, Xypnitos FN, Giannoudis PV. The role of reduction and internal fixation of Lisfranc fracture-dislocations: a systematic review of the literature. Int Orthop. 2010;34(8):1083–1091. doi: 10.1007/s00264-010-1101-x.
    1. Eleftheriou KI, Rosenfeld PF, Calder JD. Lisfranc injuries: an update. Knee Surg Sports Traumatol Arthrosc. 2013;21(6):1434–1446. doi: 10.1007/s00167-013-2491-2.
    1. Welck M, Zinchenko R, Tudor F. A painful foot: lisfranc fracture-dislocations. BMJ. 2016:12(352).
    1. Curtis MJ, Myerson M, Szura B. Tarsometatarsal joint injuries in the athlete. Am J Sports Med. 1993;21(4):497–502. doi: 10.1177/036354659302100403.
    1. Ross G, Cronin R, Hauzenblas J, Juliano P. Plantar ecchymosis sign: a clinical aid to diagnosis of occult Lisfranc tarsometatarsal injuries. J Orthop Trauma. 1996;10(2):119–122. doi: 10.1097/00005131-199602000-00008.
    1. Davies MS, Saxby TS. Intercuneiform instability and the “gap” sign. Foot Ankle Int. 1999;20(9):606–609. doi: 10.1177/107110079902000912.
    1. Siddiqui NA, Galizia MS, Almusa E, Omar IM. Evaluation of the tarsometatarsal joint using conventional radiography, CT, and MR imaging. Radiographics. 2014;34(2):514–531. doi: 10.1148/rg.342125215.
    1. Wedmore I, Young S, Franklin J. Emergency department evaluation and management of foot and ankle pain. Emerg Med Clin North Am. 2015;33(2):363–396. doi: 10.1016/j.emc.2014.12.008.
    1. Weatherford BMMD, Anderson JGMD, Bohay DRMDF. Management of Tarsometatarsal Joint Injuries. J Am Acad Orthop Surg. 2017;25(7):469–479. doi: 10.5435/JAAOS-D-15-00556.
    1. Qiao Y-sMD, Li J-kMD, Shen HMD, Bao H-yMD, Jiang MMD, Liu YMD, Kapadia WB, Zhang H-tMDP, Yang H-lP. Comparison of arthrodesis and non-fusion to treat Lisfranc injuries. Orthop Surg. 2017;
    1. Nunley JA, Vertullo CJ. Classification, investigation, and Management of Midfoot Sprains. Am J Sports Med. 2002;30(6):871–878. doi: 10.1177/03635465020300061901.
    1. Ly TV, Coetzee JC. Treatment of primarily ligamentous Lisfranc joint injuries: primary arthrodesis compared with open reduction and internal fixation. A prospective, randomized study. J Bone Joint Surg (Am Vol) 2006;88(3):514–520.
    1. Mulier T, Reynders P, Dereymaeker G, Broos P. Severe Lisfrancs injuries: primary arthrodesis or ORIF? Foot Ankle Int. 2002;23(10):902–905. doi: 10.1177/107110070202301003.
    1. Cochran G, Renninger C, Tompane T, Bellamy J, Kuhn K. Primary arthrodesis versus open reduction and internal fixation for low-energy Lisfranc injuries in a young athletic population. Foot Ankle Int. 2017;38(9):957–963. doi: 10.1177/1071100717711483.
    1. Henning JA, Jones CB, Sietsema DL, Bohay DR, Anderson JG. Open reduction internal fixation versus primary arthrodesis for lisfranc injuries: a prospective randomized study. Foot Ankle Int. 2009;30(10):913–922. doi: 10.3113/FAI.2009.0913.
    1. Smith N, Stone C, Furey A. Does open reduction and internal fixation versus primary arthrodesis improve patient outcomes for Lisfranc trauma? A systematic review and meta-analysis. Clin Orthop Relat Res. 2015;474(6):1445–1452. doi: 10.1007/s11999-015-4366-y.
    1. Shapiro MS, Wascher DC, Finerman GA. Rupture of Lisfranc’s ligament in athletes. Am J Sports Med. 1994;22(5):687–691. doi: 10.1177/036354659402200518.
    1. Meyer SA, Callaghan JJ, Albright JP, Crowley ET, Powell JW. Midfoot sprains in collegiate football players. Am J Sports Med. 1994;22(3):392–401. doi: 10.1177/036354659402200316.
    1. Faciszewski T, Burks RT, Manaster BJ. Subtle injuries of the Lisfranc joint. J Bone Joint Surg Am (Am Vol). 72(10):1519–22.
    1. Crates JM, Barber FA, Sanders EJ. Subtle Lisfranc subluxation: results of operative and nonoperative treatment. J Foot Ankle Surg. 2015;54(3):350–355. doi: 10.1053/j.jfas.2014.07.015.
    1. Goossens M, De Stoop N. Lisfranc’s fracture-dislocations: etiology, radiology, and results of treatment. A review of 20 cases. Clin Orthop Relat Res. 1983;(176):154–62.
    1. Perez Blanco R, Rodriguez Merchan C, Canosa Sevillano R, Munuera Martinez L. Tarsometatarsal fractures and dislocations. J Orthop Trauma. 1988;2(3):188–94.
    1. Arntz CT, Veith RG, Hansen ST., Jr Fractures and fracture-dislocations of the tarsometatarsal joint. J Bone Joint Surg (Am Vol) 1988;70(2):173–181. doi: 10.2106/00004623-198870020-00003.
    1. Coetzee JC, Ly TV. Treatment of primarily ligamentous Lisfranc joint injuries: primary arthrodesis compared with open reduction and internal fixation. Surgical technique. J Bone Joint Surg (Am Vol) 2007;89(Suppl 2 Pt.1):122–127. doi: 10.2106/00004623-200703001-00011.
    1. Lee CA, Birkedal JP, Dickerson EA, Vieta PA, Webb LX, Teasdall RD. Stabilization of Lisfranc joint injuries: a biomechanical study. Foot Ankle Int. 2004;25(5):365–370. doi: 10.1177/107110070402500515.
    1. Schepers T, Oprel PP, Van Lieshout EMM. Influence of approach and implant on reduction accuracy and stability in Lisfranc fracture-dislocation at the Tarsometatarsal joint. Foot Ankle Int. 2013;34(5):705–710. doi: 10.1177/1071100712468581.
    1. Alberta FG, Aronow MS, Barrero M, Diaz-Doran V, Sullivan RJ, Adams DJ. Ligamentous Lisfranc joint injuries: a biomechanical comparison of dorsal plate and Transarticular screw fixation. Foot Ankle Int. 2005;26(6):462–473. doi: 10.1177/107110070502600607.
    1. Rajapakse B, Edwards A, Hong T. A single surgeon's experience of treatment of Lisfranc joint injuries. Injury. 2006;37(9):914–921. doi: 10.1016/j.injury.2005.12.003.
    1. Rammelt S, Schneiders W, Schikore H, Holch M, Heineck J, Zwipp H. Primary open reduction and fixation compared with delayed corrective arthrodesis in the treatment of tarsometatarsal (Lisfranc) fracture dislocation. J Bone Joint Surg. 2008;90(11):1499–1506. doi: 10.1302/0301-620X.90B11.20695.
    1. Aronow MS. Treatment of the missed Lisfranc injury. Foot Ankle Clin. 2006;11(1):127–142. doi: 10.1016/j.fcl.2005.12.005.
    1. Teng AL, Pinzur MS, Lomasney L, Mahoney L, Havey R. Functional outcome following anatomic restoration of tarsal-metatarsal fracture dislocation. Foot Ankle Int. 2002;23(10):922–926. doi: 10.1177/107110070202301006.
    1. Sands AK, Grose A. Lisfranc injuries. Injury. 2004;(35, 2, Supplement):71–6.
    1. Ahmad J, Jones K. Randomized, prospective comparison of bioabsorbable and steel screw fixation of Lisfranc injuries. J Orthop Trauma. 2016;30(12):676–681. doi: 10.1097/BOT.0000000000000663.
    1. Richter M, Zech S, Geerling J, Frink M, Knobloch K, Krettek C. A new foot and ankle outcome score: questionnaire based, subjective, visual-analogue-scale, validated and computerized. Foot Ankle Surg. 2006;12(4):191–199. doi: 10.1016/j.fas.2006.04.001.
    1. Repo JP, Tukiainen EJ, Roine RP, Kautiainen H, Lindahl J, Ilves O, Järvenpää S, Häkkinen A. Reliability and validity of the Finnish version of the visual analogue scale foot and ankle (VAS-FA). Foot Ankle Surg. 2017;
    1. Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating Systems for the Ankle-Hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994;15(7):349–353. doi: 10.1177/107110079401500701.
    1. Huskisson EC. Measurement of pain. Lancet. 1974;2(7889):1127–1131. doi: 10.1016/S0140-6736(74)90884-8.
    1. Dawson J, Doll H, Coffey J, Jenkinson C, Oxford, Birmingham F, Ankle Clinical Research G Responsiveness and minimally important change for the Manchester-Oxford foot questionnaire (MOXFQ) compared with AOFAS and SF-36 assessments following surgery for hallux valgus. Osteoarthritis Cartilage. 2007;15(8):918–931. doi: 10.1016/j.joca.2007.02.003.

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