Total Hip Replacement With Ceramic on Ceramic Bearing- Clinical Follow-up Study

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04256291
Collaborator
(none)
160
1
36
4.4

Study Details

Study Description

Brief Summary

The pain and severe wear of hip joints caused by osteoarthritis, rheumatoid arthritis, avascular necrosis and trauma can be subjected to total hip replacement (THR). A hip implant consists of 4 components: acetabular cup, femoral stem, articular liner and femoral head. As an ideal material for THR, ceramic possesses excellent biocompatibility and stability in the human bodies. Moreover, ceramic-on-ceramic interface is highly wear-resistant, preventing generation of wear particles. With the development of latest fourth-generation ceramic Delta, larger femoral heads can be manufactured to conform to the size of native femoral heads. The rate of some of the complications after THR, such as dislocation, can be significantly reduced. The purpose of the present study is to carry out a clinical follow up for each patient who has received the ceramic-on-ceramic THR in order to understand the clinical outcome. Furthermore, the possible complications, such as dislocation and squeaking, can be determined.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    160 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Total Hip Replacement With Ceramic on Ceramic Bearing- Clinical Follow-up Study
    Actual Study Start Date :
    Aug 1, 2018
    Anticipated Primary Completion Date :
    Jul 31, 2021
    Anticipated Study Completion Date :
    Jul 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analogue Scale- Change from baseline at 1 year [Change from baseline at 1 year]

      Visual Analogue Scale is a patient-reported outcome measure. The scale ranges from 0 to 10. A score of 0 represents no pain, while a score of 10 represents extreme pain.

    2. Harris Hip Score- Change from baseline at 1 year [Change from baseline at 1 year]

      Harris Hip Score includes 4 sections that evaluate pain, function, deformity, and range of motion. Total scores is from 0 to 100, higher scores represent a better outcome.

    3. Oxford Hip Score- Change from baseline at 1 year [Change from baseline at 1 year]

      Oxford Hip Score is a patient-reported outcome measure with 12 questions related to the condition of function and pain. Total scores is from 0 to 48, higher scores represent a better outcome.

    4. Radiologic analysis- Change from baseline at 1 year [Change from baseline at 1 year]

      Radiologic analysis helps observe the existence of radiolucent lines, which can be analyzed to determine if implant loosening occurs.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    Patients who has received ceramic-on-ceramic total hip replacement after the year of 2013.

    Exclusion criteria:
    1. Patients who are unable or unwilling to return for follow-up

    2. Patients who have deep periprosthetic joint infection

    3. Patients who are diagnosed skeletal dysplasia

    4. Patients who suffer from mental disorders

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Orthopaedics- National Taiwan University Hospital Yunlin Branch Douliu Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Study Chair: Yang-Chen Chou, National Taiwan University Hospital Yunlin Branch
    • Study Director: Chen-Chiang Lin, National Taiwan University Hospital Yunlin Branch

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT04256291
    Other Study ID Numbers:
    • 201807006RINA
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Jan 1, 2020
    Keywords provided by National Taiwan University Hospital

    Study Results

    No Results Posted as of Feb 5, 2020