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

Sponsor
Ewha Womans University (Other)
Overall Status
Completed
CT.gov ID
NCT03639532
Collaborator
(none)
148
2
220.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: COC THA
  • Procedure: COP THA
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
148 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Is Ceramic-on-Ceramic THA Superior to Ceramic-on-Highly Cross-Linked Polyethylene THA in Patients Less Than 55 Years Old?
Actual Study Start Date :
Jan 1, 2000
Actual Primary Completion Date :
Apr 30, 2003
Actual Study Completion Date :
May 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: COC THA
standard total hip arthroplasty is done, with ceramic on ceramic for the bearing.

Active Comparator: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Harris hip score [15 years after the intervention]

    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

  1. WOMAC(Western Ontario and McMaster Universities) Scores [15 years after the intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ewha Womans University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Young Hoo Kim, Professor, Ewha Womans University
ClinicalTrials.gov Identifier:
NCT03639532
Other Study ID Numbers:
  • HXLTHA
First Posted:
Aug 21, 2018
Last Update Posted:
Aug 21, 2018
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2018