Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
148 participants
INTERVENTIONAL
2000-01-01
2018-05-31
Brief Summary
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Detailed Description
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Despite contemporary cementless THA with COC bearings giving excellent clinical and radiographic outcomes, there is concern about squeaking, fracture of the ceramic head or acetabular insert or fretting and corrosion (trunnionosis). Although HXLPE have been reported to reduce polyethylene wear, there is concerned about a potential decrease in toughness, tensile strength and resistance to the propagation of fatigue cracks in a long-term follow-up.
Several noncomparative studies of COC and COP THA have reported promising results in terms of Harris hip scores, radiographic findings, and survival rates, yet we are aware of no long-term comparative clinical studies with a COC THA and a COP THA in the same younger patients. This study aimed to see if long-term Harris hip scores and Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score better in younger patients with a COC THA compared with those with a COP THA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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COC
for the arthritic hip of the patient, total hip arthroplasty(THA) with ceramic on ceramic(COC) bearing couple is implanted. The group with intervention COC THA.
COC THA
standard total hip arthroplasty is done, with ceramic on ceramic for the bearing.
COP
for the arthritic hip of the patient, total hip arthroplasty(THA) with ceramic on highly cross-linked polyethylene bearing couple is implanted. The group with intervention COP THA.
COP THA
standard total hip arthroplasty is done, with ceramic on highly cross linked polyethylene for the bearing.
Interventions
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COC THA
standard total hip arthroplasty is done, with ceramic on ceramic for the bearing.
COP THA
standard total hip arthroplasty is done, with ceramic on highly cross linked polyethylene for the bearing.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
55 Years
ALL
No
Sponsors
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Ewha Womans University
OTHER
Responsible Party
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Young Hoo Kim
Professor
References
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Bansal A, Khatib ON, Zuckerman JD. Revision total joint arthroplasty: the epidemiology of 63,140 cases in New York State. J Arthroplasty. 2014 Jan;29(1):23-7. doi: 10.1016/j.arth.2013.04.006. Epub 2013 May 13.
Kim YH, Park JW, Park JS. The 27 to 29-year outcomes of the PCA total hip arthroplasty in patients younger than 50 years old. J Arthroplasty. 2014 Dec;29(12):2256-61. doi: 10.1016/j.arth.2014.02.011. Epub 2014 Feb 12.
Clohisy JC, Oryhon JM, Seyler TM, Wells CW, Liu SS, Callaghan JJ, Mont MA. Function and fixation of total hip arthroplasty in patients 25 years of age or younger. Clin Orthop Relat Res. 2010 Dec;468(12):3207-13. doi: 10.1007/s11999-010-1468-4.
Adelani MA, Keeney JA, Palisch A, Fowler SA, Clohisy JC. Has total hip arthroplasty in patients 30 years or younger improved? A systematic review. Clin Orthop Relat Res. 2013 Aug;471(8):2595-601. doi: 10.1007/s11999-013-2975-x. Epub 2013 Apr 6.
Kim YH, Park JW, Patel C, Kim DY. Polyethylene wear and osteolysis after cementless total hip arthroplasty with alumina-on-highly cross-linked polyethylene bearings in patients younger than thirty years of age. J Bone Joint Surg Am. 2013 Jun 19;95(12):1088-93. doi: 10.2106/JBJS.L.01211.
Capello WN, D'Antonio JA, Feinberg JR, Manley MT, Naughton M. Ceramic-on-ceramic total hip arthroplasty: update. J Arthroplasty. 2008 Oct;23(7 Suppl):39-43. doi: 10.1016/j.arth.2008.06.003.
Bascarevic Z, Vukasinovic Z, Slavkovic N, Dulic B, Trajkovic G, Bascarevic V, Timotijevic S. Alumina-on-alumina ceramic versus metal-on-highly cross-linked polyethylene bearings in total hip arthroplasty: a comparative study. Int Orthop. 2010 Dec;34(8):1129-35. doi: 10.1007/s00264-009-0899-6. Epub 2009 Nov 1.
Other Identifiers
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HXLTHA
Identifier Type: -
Identifier Source: org_study_id
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