Ceramic-on-Ceramic Versus Ceramic-on-HXLPE THA

NCT03639532 | Completed Phase 4

• 1 other identifier: HXLTHA
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Hip; Avascular Necrosis of the Femoral Head; Arthropathy of Hip; Hip Arthr

Outcome Measures

Primary Outcomes (1)

• 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)

  15 years after the intervention

Secondary Outcomes (1)

• WOMAC(Western Ontario and McMaster Universities) Scores

  15 years after the intervention

Study Arms (2)

COC

EXPERIMENTAL

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.

Procedure: COC THA

COP

ACTIVE COMPARATOR

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.

Procedure: COP THA

Interventions

COC THA PROCEDURE

standard total hip arthroplasty is done, with ceramic on ceramic for the bearing.

COC

COP THA PROCEDURE

standard total hip arthroplasty is done, with ceramic on highly cross linked polyethylene for the bearing.

COP

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• bilateral end-stage hip arthrosis

You may not qualify if:

• inflammatory arthritis, foot and ankle disorders, dementia, stroke history, high dislocation of hip, patients older than 55 years

Sponsors & Collaborators

• Ewha Womans University: lead

Related Publications (7)

• 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.

  PMID: 23680502 BACKGROUND

• 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.

  PMID: 24636903 BACKGROUND

• 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.

  PMID: 20668972 BACKGROUND

• 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.

  PMID: 23564363 BACKGROUND

• 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.

  PMID: 23783205 BACKGROUND

• 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.

  PMID: 18922373 BACKGROUND

• 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.

  PMID: 19882338 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Femur Head Necrosis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 21, 2018
• Study Start: January 1, 2000
• Primary Completion: April 30, 2003
• Study Completion: May 31, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08