Ceramic-on-Ceramic Versus Ceramic-on-HXLPE THA
Primary Purpose
Osteoarthritis, Hip, Avascular Necrosis of the Femoral Head, Arthropathy of Hip
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
COC THA
COP THA
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip
Eligibility Criteria
Inclusion Criteria:
- bilateral end-stage hip arthrosis
Exclusion Criteria:
- inflammatory arthritis, foot and ankle disorders, dementia, stroke history, high dislocation of hip, patients older than 55 years
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
COC
COP
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Harris hip score
The Harris Hip Score(HHS) was developed by William H. Harris to assess the results of hip surgery or hip replacement. The standard evaluation applies to various hip disabilities and methods of treatment in adults. The original version of the score was first published in 1969. 100 is the best score, and 0 is the worst possible score. HHS has a subset of pain(44 points), function(47 points), absence of deformity(4 points), and range of motion(5 points)
Secondary Outcome Measures
WOMAC(Western Ontario and McMaster Universities) Scores
A tool to evaluate patient function associated with knee. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The total score is summed from individual sections, and 0 is the best possible score.
Full Information
NCT ID
NCT03639532
First Posted
August 15, 2018
Last Updated
August 19, 2018
Sponsor
Ewha Womans University
1. Study Identification
Unique Protocol Identification Number
NCT03639532
Brief Title
Ceramic-on-Ceramic Versus Ceramic-on-HXLPE THA
Official Title
Is Ceramic-on-Ceramic THA Superior to Ceramic-on-Highly Cross-Linked Polyethylene THA in Patients Less Than 55 Years Old?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2000 (Actual)
Primary Completion Date
April 30, 2003 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Methods to reduce the revision rate of total hip arthroplasties (THAs) because of wear-related issues are important to examine, particularly because younger patients have a disproportionately high risk of revision. The investigators hoped to follow up patients and see if long-term Harris hip scores and WOMAC scores better in younger patients with a ceramic-on-ceramic (COC) THA compared with those with a ceramic-on-highly-cross-linked polyethylene (COP) THA.
Detailed Description
High success rates obtained in the general population have stimulated for total hip arthroplasty (THA) in young and active patients. Although there have been substantial improvements in THA, bearing surface wear and osteolysis are major factors limiting the durability of THAs in young and active patients. During the last decade, alternative bearings have been developed, including highly cross-linked polyethylene (HXLPE) and ceramic-on-ceramic (COC) bearings, with the potential to reduce wear and osteolysis in younger, more active patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Avascular Necrosis of the Femoral Head, Arthropathy of Hip, Hip Arthr
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COC
Arm Type
Experimental
Arm Description
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.
Arm Title
COP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
COC THA
Intervention Description
standard total hip arthroplasty is done, with ceramic on ceramic for the bearing.
Intervention Type
Procedure
Intervention Name(s)
COP THA
Intervention Description
standard total hip arthroplasty is done, with ceramic on highly cross linked polyethylene for the bearing.
Primary Outcome Measure Information:
Title
Harris hip score
Description
The Harris Hip Score(HHS) was developed by William H. Harris to assess the results of hip surgery or hip replacement. The standard evaluation applies to various hip disabilities and methods of treatment in adults. The original version of the score was first published in 1969. 100 is the best score, and 0 is the worst possible score. HHS has a subset of pain(44 points), function(47 points), absence of deformity(4 points), and range of motion(5 points)
Time Frame
15 years after the intervention
Secondary Outcome Measure Information:
Title
WOMAC(Western Ontario and McMaster Universities) Scores
Description
A tool to evaluate patient function associated with knee. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The total score is summed from individual sections, and 0 is the best possible score.
Time Frame
15 years after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
bilateral end-stage hip arthrosis
Exclusion Criteria:
inflammatory arthritis, foot and ankle disorders, dementia, stroke history, high dislocation of hip, patients older than 55 years
12. IPD Sharing Statement
Citations:
PubMed Identifier
23680502
Citation
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.
Results Reference
background
PubMed Identifier
24636903
Citation
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.
Results Reference
background
PubMed Identifier
20668972
Citation
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.
Results Reference
background
PubMed Identifier
23564363
Citation
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.
Results Reference
background
PubMed Identifier
23783205
Citation
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.
Results Reference
background
PubMed Identifier
18922373
Citation
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.
Results Reference
background
PubMed Identifier
19882338
Citation
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.
Results Reference
background
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Ceramic-on-Ceramic Versus Ceramic-on-HXLPE THA
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