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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03639532
Enrollment
148
Registered
2018-08-21
Start date
2000-01-01
Completion date
2018-05-31
Last updated
2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDURECOC THA

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

PROCEDURECOP THA

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

Sponsors

Ewha Womans University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Harris hip score15 years after the interventionThe 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

MeasureTime frameDescription
WOMAC(Western Ontario and McMaster Universities) Scores15 years after the interventionA 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026