Elbow hemiarthroplasty versus open reduction and internal fixation for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above: a randomized controlled trial

Ali Al-Hamdani, Jeppe V Rasmussen, Kenneth Holtz, Bo S Olsen, Ali Al-Hamdani, Jeppe V Rasmussen, Kenneth Holtz, Bo S Olsen

Abstract

Background: Intraarticular distal humeral fractures of AO/OTA type 13 C2 and C3 pose a surgical challenge despite the evolution of surgical implants and techniques. Open reduction and internal fixation (ORIF) is often preferred as the first choice of treatment, but the results vary and are sometimes disappointing. Total elbow arthroplasty (TEA) has been widely used for fractures that are not amenable to ORIF in elderly patients, but the mechanical complications remain a challenge, especially in active patients. Elbow hemiarthroplasty (EHA) provides a modern alternative that might avoid the mechanical complications and weight bearing restrictions related to the linked articulation in semi-constrained TEA. No studies have compared the results of EHA to that of ORIF, but case series have reported promising results.

Methods/design: This is a study protocol describing an investigator-initiated, non-blinded randomized controlled trial comparing the outcome of EHA with ORIF for AO/OTA type 13 C2 and C3 fractures of the distal humerus in patients who are 50 years or older. Forty-four patients with AO/OTA type 13 C2 and C3 fractures of distal humerus will be randomized to either EHA or ORIF. The Oxford Elbow Score (OES) will be used as primary outcome. Mayo Elbow Performance Score (MEPS), pain severity score (VAS), range of motion, and patient satisfaction will be used as secondary outcomes. Reoperations, complications, and the length of sick leave will be recorded. The patients will be examined after the operation and at 3 months and 1, 2, 5, and 10 years.

Discussion: The main objective of this study is to investigate the best treatment option for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above. We hypothesize that EHA results in fewer complications and superior functional outcome compared with ORIF and that the mechanical complications related to the linked articulation of TEA can be avoided.

Trial registration: ClinicalTrials.gov, PRS, NCT04163172. Registered November 13, 2019. https://clinicaltrials.gov/ct2/results?cond=&term=evori&cntry=&state=&city=&dist= (Table 2). The protocol has been approved by The Scientific Ethics Committee of the Capital Region of Denmark (Jr. no.: H- 19,035,590). The processing of personal data has been approved by the Danish Data Protection Agency (Jr. no. P-2019-246). Inclusion started on February 1, 2020.

Keywords: Complication; Elbow; Fracture; Hemiarthroplasty; Humerus; Osteosynthesis; Outcome; Randomized; Reoperation.

Conflict of interest statement

The authors declare that they have no competing interests.

References

    1. Al-Hamdani A, Rasmussen JV, Sørensen AKB, Ovesen J, Holtz K, Brorson S, Olsen BS. Good outcome after elbow hemiarthroplasty in active patients with an acute intra-articular distal humeral fracture. J Shoulder Elbow Surg. 2019. 10.1016/j.jse.2018.10.018.
    1. Amir S, Jannis S, Daniel R. Distal humerus fractures: a review of current therapy concepts. Curr Rev Musculoskelet Med. 2016;9:199–206. doi: 10.1007/s12178-016-9341-z.
    1. Celik D. Psychometric properties of the Mayo Elbow Performance Score. Rheumatol Int. 2015;35:1015–1020. doi: 10.1007/s00296-014-3201-1.
    1. Cusick MC, Bonnaig NS, Azar FM, Mauck BM, Smith RA, Throckmorton TW. Accuracy and reliability of the Mayo Elbow Performance Score. J Hand Surg Am. 2014;39:1146–1150. doi: 10.1016/j.jhsa.2014.01.041.
    1. Dawson J, Doll H, Boller I, Fitzpatrick R, Little C, Rees J, Carr A. Comparative responsiveness and minimal change for the Oxford Elbow Score following surgery. Qual Life Res. 2008;17(10):1257–1267. doi: 10.1007/s11136-008-9409-3.
    1. Dawson J, Doll H, Boller I, Fitzpatrick R, Little C, Rees J, Jenkinson C, Carr AJ. The development and validation of a patient-reported questionnaire to assess outcomes of elbow surgery. J Bone Joint Surg Br. 2008;90(4):466–473. doi: 10.1302/0301-620X.90B4.20290.
    1. Dee R. Total replacement arthroplasty of the elbow for rheumatoid arthritis. J Bone Joint Surg Br. 1972;54(1):88–95. doi: 10.1302/0301-620X.54B1.88.
    1. Dehghan N, Furey M, Schemitsch L, Ristevski B, Goetz T, Schemitsch EH, McKee M. Long-term outcomes of total elbow arthroplasty for distal humeral fracture: results from a prior randomized clinical trial. J Shoulder Elbow Surg. 2019. 10.1016/j.jse.2019.06.004 [Epub ahead of print] PMID: 31445787.
    1. Egol KA, Tsai P, Vazques O, Tejwani NC. Comparison of functional outcomes of total elbow arthroplasty vs plate fixation for distal humerus fractures in osteoporotic elbows. Am J Orthop (Belle Mead NJ) 2011;40(2):67–71.
    1. Frattini M, Soncini G, Corradi M, Panno B, Tocco S, Pogliacomi F. Mid-term results of complex distal humeral fractures. Musculoskelet Surg. 2011;95:205–213. doi: 10.1007/s12306-011-0132-9.
    1. Githens M, Yao J, Sox AH, Bishop J. Open reduction and internal fixation versus total elbow arthroplasty for the treatment of geriatric distal humerus fractures: a systematic review and meta-analysis. J Orthop Trauma. 2014;28(8):481–488. doi: 10.1097/BOT.0000000000000050.
    1. Holdsworth BJ, Mossad MM. Fractures of the adult distal humerus. Elbow function after internal fixation. J Bone Joint Surg (Br) 1990;72(3):362–365. doi: 10.1302/0301-620X.72B3.2341427.
    1. Iordens GIT, Den Hartog D, Tuinebreijer WE, Eygendaal D, Schep NWL, Verhofstad MHJ, et al. Minimal important change and other measurement properties of the Oxford Elbow Score and the Quick Disabilities of the Arm, Shoulder, and Hand in patients with a simple elbow dislocation; validation study alongside the multicenter. FuncSiE Trial Investigators. PLoS One. 2017;12:e0182557. doi: 10.1371/journal.pone.0182557.
    1. Iwamoto T, Ikegami H, Suzuki T, Oki S, Matsumura N, Nakamura M, Matsumoto M, Sato K. The history and future of unlinked total elbow arthroplasty. Keio J Med. 2018;67(2):19–25. doi: 10.2302/kjm.2017-0007-IR.
    1. Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001;18(3):205–207. doi: 10.1136/emj.18.3.205.
    1. Levy JC, Loeb M, Chuinard C, Adams RA, Morrey BF. Effectiveness of revision following linked versus unlinked total elbow arthroplasty. J Shoulder Elb Surg. 2009;18:457–462. doi: 10.1016/j.jse.2008.11.016.
    1. McKee MD, Veillette CJ, Hall JA, Schemitsch EH, Wild LM, McCormack R, Perey B, Goetz T, Zomar M, Moon K, Mandel S, Petit S, Guy P, Leung I. A multicenter, prospective, randomized, controlled trial of open reduction--internal fixation versus total elbow arthroplasty for displaced intra-articular distal humeral fractures in elderly patients. J Shoulder Elbow Surg. 2009;18(1):3–12. doi: 10.1016/j.jse.2008.06.005.
    1. Morrey BF, An KN. Functional evaluation of the elbow. In: Morrey BF, editor. The elbow and its disorders. 3. Philadelphia: WB Saunders; 2000. p. 82.
    1. Nestorson J, Ekholm C, Etzner M, Adolfsson L. Hemiarthroplasty for irreparable distal humeral fractures. Bone Joint J. 2015;97-B:1377–1384. doi: 10.1302/0301-620X.97B10.35421.ø.
    1. Phadnis J, Banerjee S, Watts AC, Little N, Hearnden A, Patel VR. Elbow hemiarthroplasty using a "triceps-on" approach for the management of acute distal humeral fractures. J Shoulder Elb Surg. 2015;24:1178–1186. doi: 10.1016/j.jse.2015.04.010.
    1. Plaschke HC, Jørgensen A, Thillemann TM, Brorson S, Olsen BS. Validation of the Danish version of the Oxford Elbow Score. Dan Med J. 2013;60:A4714.
    1. Robinson CM, Hill RM, Jacobs N, Dall G, Court-Brown CM. Adult distal humeral metaphyseal fractures: epidemiology and results of treatment. J Orthop Trauma. 2003;17:38–47. doi: 10.1097/00005131-200301000-00006.
    1. Schoch B, Wong J, Abboud J, Lazarus M, Getz C, Ramsey M. Results of total elbow arthroplasty in patients less than 50 years old. J Hand Surg Am. 2017;42:797–802. doi: 10.1016/j.jhsa.2017.06.101.
    1. Schultzel M, Scheidt K, Klein CC, Narvy SJ, Lee BK, Itamura JM. Hemiarthroplasty for the treatment of distal humeral fractures: midterm clinical results. J Shoulder Elb Surg. 2017;26:389–393. doi: 10.1016/j.jse.2016.09.057.
    1. Scolaro JA, Hsu JE, Svach DJ, Mehta S. Plate selection for fixation of extra-articular distal humerus fractures: a biomechanical comparison of three different implants. Injury. 2014;45(12):2040–2044. doi: 10.1016/j.injury.2014.08.036.
    1. Smith GC, Bayne G, Page R, Hughes JS. The clinical outcome and activity levels of patients under 55 years treated with distal humeral hemiarthroplasty for distal humeral fractures. Shoulder Elbow. 2016;8:264–270. doi: 10.1177/1758573216660958.
    1. Sørensen BW, Brorson S, Olsen BS. Primary total elbow arthroplasty in complex fractures of the distal humerus. World J Orthop. 2014;5:368–372. doi: 10.5312/wjo.v5.i3.368.
    1. Todd KH, Funk JP. The minimum clinically important difference in physician-assigned visual analog pain scores. Acad Emerg Med. 1996;3(2):142–146. doi: 10.1111/j.1553-2712.1996.tb03402.x.
    1. Varady PA, von Rüden C, Greinwald M, Hungerer S, Pätzold R, Augat P. Biomechanical comparison of anatomical plating systems for comminuted distal humeral fractures. Int Orthop. 2017;41(9):1709–1714. doi: 10.1007/s00264-017-3444-z.
    1. Voloshin I, Schippert DW, Kakar S, Kaye EK, Morrey BF. Complications of total elbow replacement: a systematic review. J Shoulder Elbow Surg. 2011;20:158–168. doi: 10.1016/j.jse.
    1. Welsink CL, Lambers KTA, van Deurzen DFP, Eygendaal D, van den Bekerom MPJ. Total elbow arthroplasty: a systematic review. JBJS Rev. 2017;5:e4. doi: 10.2106/JBJS.RVW.16.00089.

Source: PubMed

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