The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field to standardize how to conduct, and to assist in the reasoning and decision-making of doctors. The information provided by this project must be critically evaluated by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical condition of each patient.
| Author/Year | Randomization | Blinded allocation | Double blind | Evaluator blinding | Losses | Prognostic characteristics | Outcomes | ITT | Sample calculation | Early interruption |
|---|---|---|---|---|---|---|---|---|---|---|
| Bjorgul, et al.1616. Bjorgul K, Novicoff WN, Andersen ST, Ahlund OR, Bunes A, Wiig M, et al. High rate of revision and a high incidence of radiolucent lines around Metasul metal-on-metal total hip replacements: results from a randomised controlled trial of three bearings after seven years. Bone Joint J. 2013;95-B(7):881-6. https://doi.org/10.1302/0301-620X.95B7.31067 https://doi.org/10.1302/0301-620X.95B7.3... |
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| Ise, et al.1717. Ise K, Kawanabe K, Tamura J, Akiyama H, Goto K, Nakamura T. Clinical results of the wear performance of cross-linked polyethylene in total hip arthroplasty: prospective randomized trial. J Arthroplasty. 2009;24(8):1216-20. https://doi.org/10.1016/j.arth.2009.05.020 https://doi.org/10.1016/j.arth.2009.05.0... |
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| Jassim, et al.1818. Jassim SS, Patel S, Wardle N, Tahmassebi J, Middleton R, Shardlow DL, et al. Five-year comparison of wear using oxidized zirconium and cobalt- chrome femoral heads in total hip arthroplasty: a multicentre randomised controlled trial. Bone Joint J. 2015;97-B(7):883-9. https://doi.org/10.1302/0301-620X.97B7.35285 https://doi.org/10.1302/0301-620X.97B7.3... |
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| Jonsson, et al.1919. Jonsson BA, Kadar T, Havelin LI, Haugan K, Espehaug B, Indrekvam K, et al. Oxinium modular femoral heads do not reduce polyethylene wear in cemented total hip arthroplasty at five years: a randomised trial of 120 hips using radiostereometric analysis. Bone Joint J. 2015;97-B(11):1463-9. https://doi.org/10.1302/0301-620X.97B11.36137 https://doi.org/10.1302/0301-620X.97B11.... |
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| Kadar, et al.2020. Kadar T, Hallan G, Aamodt A, Indrekvam K, Badawy M, Skredderstuen A, et al. Wear and migration of highly cross-linked and conventional cemented polyethylene cups with cobalt chrome or Oxinium femoral heads: a randomized radiostereometric study of 150 patients. JOrthop Res. 2011;29(8):1222-9. https://doi.org/10.1002/jor.21389 https://doi.org/10.1002/jor.21389... |
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| Kawate, et al.2121. Kawate K, Ohmura T, Kawahara I, Tamai K, Ueha T, Takemura K. Differences in highly cross-linked polyethylene wear between zirconia and cobalt-chromium femoral heads in Japanese patients: a prospective, randomized study. J Arthroplasty. 2009;24(8):1221-4. https://doi.org/10.1016/j.arth.2009.05.023 https://doi.org/10.1016/j.arth.2009.05.0... |
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| Kim2222. Kim YH. Comparison of polyethylene wear associated with cobalt-chromium andzirconia heads after total hip replacement. A prospective, randomized study. J Bone Joint Surg Am. 2005;87(8):1769-76. https://doi.org/10.2106/JBJS.D.02572 https://doi.org/10.2106/JBJS.D.02572... |
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| Kraay, et al.2323. Kraay MJ, Thomas RD, Rimnac CM, Fitzgerald SJ, Goldberg VM. Zirconia versus Co-Cr femoral heads in total hip arthroplasty: early assessment of wear. Clin Orthop Relat Res. 2006;453:86-90. https://doi.org/10.1097/01.blo.0000246544.95316.1f https://doi.org/10.1097/01.blo.000024654... |
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| Morison, et al.2424. Morison ZA, Patil S, Khan HA, Bogoch ER, Schemitsch EH, Waddell JP. A randomized controlled trial comparing Oxinium and cobalt-chrome on standard and cross-linked polyethylene. J Arthroplasty. 2014;29(Suppl 9):164-8. https://doi.org/10.1016/j.arth.2014.04.046 https://doi.org/10.1016/j.arth.2014.04.0... |
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| Nakahara, et al.2525. Nakahara I, Nakamura N, Nishii T, Miki H, Sakai T, Sugano N. Minimum five-year follow-up wear measurement of longevity highly cross-linked polyethylene cup against cobalt-chromium or zirconia heads. J Arthroplasty. 2010;25(8):1182-7. https://doi.org/10.1016/j.arth.2009.09.006 https://doi.org/10.1016/j.arth.2009.09.0... |
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| Zaoui, et al.2626. Zaoui A, Hage SE, Langlois J, Scemama C, Courpied JP, Hamadouche M. Do oxidized zirconium femoral heads reduce polyethylene wear in cemented THAs? A blinded randomized clinical trial. Clin Orthop Relat Res. 2015;473(12):3822-8. https://doi.org/10.1007/s11999-015-4414-7 https://doi.org/10.1007/s11999-015-4414-... |
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| Bergvinsson, et al.2727. Bergvinsson H, Sundberg M, Flivik G. Polyethylene Wear With Ceramic and Metal Femoral Heads at 5 Years: A Randomized Controlled Trial With Radiostereometric Analysis. J Arthroplasty. 2020;35(12):3769-76. https://doi.org/10.1016/j.arth.2020.06.057 https://doi.org/10.1016/j.arth.2020.06.0... |
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| Kayani, et al.2828. Kayani B, Baawa-Ameyaw J, Fontalis A, Tahmassebi J, Wardle N, Middleton R, Stephen A, Hutchinson J, Haddad FS. Oxidized zirconium versus cobalt-chrome femoral heads in total hip arthroplasty: a multicentre prospective randomized controlled trial with ten years’ follow-up. Bone Joint J. 2022;104-B(7):833-43. https://doi.org/10.1302/0301-620X.104B7.BJJ-2021-1673.R1 https://doi.org/10.1302/0301-620X.104B7.... |
| Certainty assessment | No of patients | Effect | Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Intervention (%) | Comparison (%) | Relative (95%CI) | Absolute (95%CI) | ||
| 1. Linear wear (mm/y) XLPE | ||||||||||||
| 9 | Randomized trials | Seriousa a Absence of analysis by intention of treatment; ,b b Absence of blinding; | Not serious | Not serious | Not serious | None | 448 | 443 | – | MD 0 (0.01 minor to 0) | ⊕⊕⊕◯ moderate | |
| 2. Linear wear (mm/y) UHMWPE | ||||||||||||
| 4 | Randomized trials | Seriousa a Absence of analysis by intention of treatment; ,b b Absence of blinding; | Not serious | Not serious | Not serious | None | 67 | 71 | – | MD 0 (0.04 minor to 0.05 higher) | ⊕⊕⊕◯ moderate | |
| 3. Surgical reviews | ||||||||||||
| 7 | Randomized trials | Seriousa a Absence of analysis by intention of treatment; ,b b Absence of blinding; | Not serious | Not serious | Seriousc c Long confidence interval; | None | 2/400 (0.5) | 5/400 (1.3) | Not estimable | 10 more for 1.000 (from 10 less to 20 more) | ⊕⊕◯◯ low | |
| 4. Head size | ||||||||||||
| 11 | Randomized Trials | Very seriousa a Absence of analysis by intention of treatment; ,b b Absence of blinding; ,d d Absence of sample calculation; | Very seriouse e High heterogeneity. | Very seriouse e High heterogeneity. | Seriousc c Long confidence interval; | None | 518 | 536 | – | SMD 0.75 higher (0.52 lowest to 2.03 highest) | ⊕◯◯◯ very low | |
| 5. Harris hip score (HHS) | ||||||||||||
| 5 | Randomized trials | Very seriousa a Absence of analysis by intention of treatment; ,b b Absence of blinding; ,d d Absence of sample calculation; | Not serious | Not serious | Seriousc c Long confidence interval; | None | 147 | 155 | – | MD 5.02 smaller (7.3 minor to 2.73 minor) | ⊕◯◯◯ very low | |
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