One and two-year clinical outcomes for a polyethylene glenoid with a fluted peg: one thousand two hundred seventy individual patients from eleven centers
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Clinical shoulder science lacks a benchmark against which the early clinical value of new glenoid components can be compared; such a benchmark may be derived from a multicenter study of patients receiving an established, internationally used design of glenoid component.
We obtained data from 11 centers on 1270 patients having total shoulder arthroplasty using an all-polyethylene component with a fluted central peg. We analyzed individual patient outcomes at 1 and 2 years after surgery. We compared the improvement for each patient to the minimal clinically important difference (MCID) and calculated each patient’s improvement as a percent of maximal possible improvement (MPI).
The preoperative scores improved from SST 3 ± 2, ASES 37 ± 15, Constant score 36 ± 16, and Penn score 30 ± 19 to SST 10 ± 2, ASES 90 ± 12, Constant 76 ± 13, and Penn 80 ± 24 (p < 0.001 for each). A high percentage of patients improved by more than the MCID (SST 96%, ASES 98%, Constant 94%, Penn 93%) and obtained improvement of at least 30% of the MPI (SST 95%, ASES 98%, Constant 91%, Penn 87%). The clinical outcomes realized with this glenoid design were not worse for the 41% of shoulders with preoperative type B glenoids or for the 30% of shoulders with more than 15 degrees of glenoid retroversion.
Individual patients from 11 international practices having total shoulder arthroplasty using a basic glenoid component design obtained highly significant clinical outcomes, providing a benchmark against which the early outcomes of new designs can be compared to determine whether they provide increased clinical value.
KeywordsGlenoid Ingrowth All-polyethylene Peg Clinical outcomes Minimal clinically important difference Percentage of maximal possible improvement
We thank Susan DeBartolo, University of Washington, Department of Orthopaedics and Sports Medicine, (blinded for review purposes) for her editorial work on this manuscript.
There was no extramural funding for this investigation.
Compliance with ethical standards
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This was a retrospective cohort study approved by our Institutional Review Board (HSD# STUDY00001714). For this type of study, formal consent is not required.
Conflict of interest
Financial remuneration the authors, or any member of their family, may have received directly related to the subject of the article: none.
The following is blinded for review purposes:
Dr. Matsen (first and corresponding author), Dr. De Wilde, Dr. Groh, Dr. Kilian, Dr. Merolla, Mr. Neradilek, Dr. Porcellini, Ms. Russ, Dr. Somerson, and Dr. Vidil have no conflict of interests to report.
The following doctors have conflict of interests outside of the submitted work as noted:
Dr. Iannotti reports personal fees from DePuy Synthes, personal fees from DJO Surgical, personal fees from Wright Tornier, from null, outside the submitted work.
Dr. Churchill reports personal fees from Wright Medical Tornier, Inc., during the conduct of the study; personal fees from Wright Medical Tornier, Inc., outside the submitted work. In addition, Dr. Churchill has a patent Glenoid Anchor Post licensed to Tornier Inc.
Dr. Edwards reports personal fees and non-financial support from Wright Medical Inc., during the conduct of the study; personal fees and non-financial support from Wright Medical Inc., outside the submitted work; and royalties and consulting fees from Wright Medical Inc. & DJO.
Dr. Evans reports other from DePuy-Johnson and Johnson, outside the submitted work.
Dr. Fehringer reports grants from University of Nebraska Medical Center, other from Wright Medical, during the conduct of the study.
Dr. Kelly reports other from Wright Medical, during the conduct of the study; personal fees and other from Wright Medical, outside the submitted work.
Dr. Norris reports personal fees and other from Wright Medical, during the conduct of the study.
Dr. Spencer reports personal fees from Tornier/Wright, outside the submitted work.
Dr. Wirth reports other from DePuy-Johnson and Johnson, other from Wright Medical, other from Elsevier, grants from Arthrex, outside the submitted work. In addition, Dr. Wirth has a patent with royalties paid.
- 1.Australian Government Department of Health Therapeutic Goods Administration (2012) SMR L2 metal back glenoid component (used in shoulder replacements). Product discontinued. Available at: https://www.tga.gov.au/alert/smr-l2-metal-back-glenoid-component-used-shoulder-replacements. Accessed 13 Feb 2018
- 2.Australian Orthopaedic Association (2017) Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Hip, knee & shoulder arthroplasty. Table ST30. Adelaide: AOA; Available at: https://aoanjrr.sahmri.com/documents/10180/397736/Hip%2C%20Knee%20%26%20Shoulder%20Arthroplasty. Accessed 13 Feb 2018
- 4.Buckingham BP, Parsons IM, Campbell B, Titelman RM, Smith KL, Matsen FA 3rd (2005) Patient functional self-assessment in late glenoid component failure at three to eleven years after total shoulder arthroplasty. J Shoulder Elb Surg 14(4):368–374. https://doi.org/10.1016/j.jse.2004.10.008 Blinded for review purposes.
- 5.Hsu JE, Hackett DJ Jr, Vo KV, Matsen FA 3rd (2018) What can be learned from an analysis of 215 glenoid component failures? J Shoulder Elb Surg 27(3):478–486. https://doi.org/10.1016/j.jse.2017.09.029 Blinded for review purposes.
- 7.Matsen FA 3rd, Clinton J, Lynch J, Bertelsen A, Richardson ML (2008) Glenoid component failure in total shoulder arthroplasty. J Bone Joint Surg Am 90(4):885–896. https://doi.org/10.2106/JBJS.G.01263 Blinded for review purposes.
- 8.Papadonikolakis A, Matsen FA 3rd (2014) Metal-backed glenoid components have a higher rate of failure and fail by different modes in comparison with all-polyethylene components: a systematic review. J Bone Joint Surg Am 96(12):1041–1047. https://doi.org/10.2106/JBJS.M.00674 Blinded for review purposes.
- 9.Papadonikolakis A, Neradilek MB, Matsen FA 3rd (2013) Failure of the glenoid component in anatomic total shoulder arthroplasty: a systematic review of the English-language literature between 2006 and 2012. J Bone Joint Surg Am 95(24):2205–2212. https://doi.org/10.2106/JBJS.L.00552 Blinded for review purposes.
- 10.U.S. Food and Drug Administration (2016) Zimmer Biomet recalls comprehensive reverse shoulder due to high fracture rate. Silver Spring; Available at: https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm541862.htm. Accessed 4 Mar 2018
- 12.Somerson JS, Neradilek MB, Hsu JE, Service BC, Gee AO, Matsen FA 3rd (2017) Is there evidence that the outcomes of primary anatomic and reverse shoulder arthroplasty are getting better? Int Orthop 41(6):1235–1244. https://doi.org/10.1007/s00264-017-3443-0 Blinded for review purposes.
- 13.Arnold RM, High RR, Grosshans KT, Walker CW, Fehringer EV (2011) Bone presence between the central peg’s radial fins of a partially cemented pegged all poly glenoid component suggest few radiolucencies. J Shoulder Elb Surg 20(2):315–321. https://doi.org/10.1016/j.jse.2010.05.025 CrossRefGoogle Scholar
- 16.Edwards TB, Labriola JE, Stanley RJ, O'Connor DP, Elkousy HA, Gartsman GM (2010) Radiographic comparison of pegged and keeled glenoid components using modern cementing techniques: a prospective randomized study. J Shoulder Elb Surg 19(2):251–257. https://doi.org/10.1016/j.jse.2009.10.013 CrossRefGoogle Scholar
- 21.Kilian CM, Morris BJ, Sochacki KR, Gombera MM, Haigler RE, O'Connor DP, Edwards TB (2018) Radiographic comparison of finned, cementless central pegged glenoid component and conventional cemented pegged glenoid component in total shoulder arthroplasty: a prospective randomized study. J Shoulder Elb Surg 27(6S):S10–S16. https://doi.org/10.1016/j.jse.2017.09.014 CrossRefGoogle Scholar
- 22.Kilian CM, Press CM, Smith KM, O'Connor DP, Morris BJ, Elkousy HA, Gartsman GM, Edwards TB (2017) Radiographic and clinical comparison of pegged and keeled glenoid components using modern cementing techniques: midterm results of a prospective randomized study. J Shoulder Elb Surg 26(12):2078–2085. https://doi.org/10.1016/j.jse.2017.07.016 CrossRefGoogle Scholar
- 23.Merolla G, Ciaramella G, Fabbri E, Walch G, Paladini P, Porcellini G (2016) Total shoulder replacement using a bone ingrowth central peg polyethylene glenoid component: a prospective clinical and computed tomography study with short- to mid-term follow-up. Int Orthop 40(11):2355–2363. https://doi.org/10.1007/s00264-016-3255-7 CrossRefPubMedGoogle Scholar
- 25.Parks DL, Casagrande DJ, Schrumpf MA, Harmsen SM, Norris TR, Kelly JD 2nd (2016) Radiographic and clinical outcomes of total shoulder arthroplasty with an all-polyethylene pegged bone ingrowth glenoid component: prospective short- to medium-term follow-up. J Shoulder Elb Surg 25(2):246–255. https://doi.org/10.1016/j.jse.2015.07.008 CrossRefGoogle Scholar
- 27.Service BC, Hsu JE, Somerson JS, Russ SM, Matsen FA 3rd (2017) Does postoperative glenoid retroversion affect the 2-year clinical and radiographic outcomes for total shoulder arthroplasty? Clin Orthop Relat Res 475(11):2726–2739. https://doi.org/10.1007/s11999-017-5433-3 Blinded for review purposes.
- 31.Wirth MA, Loredo R, Garcia G, Rockwood CA Jr, Southworth C, Iannotti JP (2012) Total shoulder arthroplasty with an all-polyethylene pegged bone-ingrowth glenoid component: a clinical and radiographic outcome study. J Bone Joint Surg Am 94(3):260–267. https://doi.org/10.2106/JBJS.J.01400 CrossRefPubMedGoogle Scholar
- 32.Bercik MJ, Kruse K 2nd, Yalizis M, Gauci MO, Chaoui J, Walch G (2016) A modification to the Walch classification of the glenoid in primary glenohumeral osteoarthritis using three-dimensional imaging. J Shoulder Elb Surg 25(10):1601–1606. https://doi.org/10.1016/j.jse.2016.03.010 CrossRefGoogle Scholar
- 38.Gilmer BB, Comstock BA, Jette JL, Warme WJ, Jackins SE, Matsen FA 3rd (2012) The prognosis for improvement in comfort and function after the ream-and-run arthroplasty for glenohumeral arthritis: an analysis of 176 consecutive cases. J Bone Joint Surg 94(14):e102. https://doi.org/10.2106/JBJS.K.00486 Blinded for review purposes.
- 39.Matsen FA 3rd, Russ SM, Vu PT, Hsu JE, Lucas RM, Comstock BA (2016) What factors are predictive of patient-reported outcomes? A prospective study of 337 shoulder arthroplasties. Clin Orthop Relat Res 474(11):2496–2510. https://doi.org/10.1007/s11999-016-4990-1 Blinded for review purposes.
- 40.McElvany MD, McGoldrick E, Gee AO, Neradilek MB, Matsen FA 3rd (2015) Rotator cuff repair: published evidence on factors associated with repair integrity and clinical outcome. Am J Sports Med 43(2):491–500. https://doi.org/10.1177/0363546514529644 Blinded for review purposes.
- 41.Somerson JS, Sander P, Bohsali KI, Tibbetts R, Rockwood CA Jr, Wirth MA (2016) What factors are associated with clinically important improvement after shoulder hemiarthroplasty for cuff tear arthropathy? Clin Orthop Relat Res 474(12):2682–2688. https://doi.org/10.1007/s11999-016-5037-3 Blinded for review purposes.
- 42.R Core Team (2017) R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; Available at: https://www.R-project.org/. Accessed 4 Mar 2018
- 48.Ricchetti ET, Jun BJ, Cain RA, Youderian A, Rodriguez EJ, Kusin D, Subhas N, Patterson TE, Iannotti JP (2018) Sequential 3-dimensional computed tomography analysis of implant position following total shoulder arthroplasty. J Shoulder Elb Surg 27(6):973–992. https://doi.org/10.1016/j.jse.2017.12.012 CrossRefGoogle Scholar
- 49.Nelson CG, Brolin TJ, Ford MC, Smith RA, Azar FM, Throckmorton TW (2018) Five-year minimum clinical and radiographic outcomes of total shoulder arthroplasty using a hybrid glenoid component with a central porous titanium post. J Shoulder Elb Surg 27(8):1462–1467. https://doi.org/10.1016/j.jse.2018.01.012 CrossRefGoogle Scholar
- 50.Walch G, Young AA, Boileau P, Loew M, Gazielly D, Mole D (2012) Patterns of loosening of polyethylene keeled glenoid components after shoulder arthroplasty for primary osteoarthritis: results of a multicenter study with more than five years of follow-up. J Bone Joint Surg Am 94(2):145–150. https://doi.org/10.2106/JBJS.J.00699 CrossRefPubMedGoogle Scholar
- 53.Karelse A, Leuridan S, Van Tongel A, Debeer P, Van Der Sloten J, Denis K, De Wilde LF (2015) Consequences of reaming with flat and convex reamers for bone volume and surface area of the glenoid; a basic science study. J Orthop Surg Res 10:181. https://doi.org/10.1186/s13018-015-0312-7 CrossRefPubMedPubMedCentralGoogle Scholar
- 55.Lyman S, Jones EC, Bach PB, Peterson MG, Marx RG (2005) The association between hospital volume and total shoulder arthroplasty outcomes. Clin Orthop Relat Res (432):132–137Google Scholar