Clinical Trials Directory

Trials / Completed

CompletedNCT03639532

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

Is Ceramic-on-Ceramic THA Superior to Ceramic-on-Highly Cross-Linked Polyethylene THA in Patients Less Than 55 Years Old?

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
148 (actual)
Sponsor
Ewha Womans University · Academic / Other
Sex
All
Age
20 Years – 55 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECOC THAstandard total hip arthroplasty is done, with ceramic on ceramic for the bearing.
PROCEDURECOP THAstandard total hip arthroplasty is done, with ceramic on highly cross linked polyethylene for the bearing.

Timeline

Start date
2000-01-01
Primary completion
2003-04-30
Completion
2018-05-31
First posted
2018-08-21
Last updated
2018-08-21

Source: ClinicalTrials.gov record NCT03639532. Inclusion in this directory is not an endorsement.