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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04256291
Enrollment
160
Registered
2020-02-05
Start date
2018-08-01
Completion date
2021-07-31
Last updated
2020-02-05

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

Conditions

Total Hip Arthroplasty, Total Hip Replacement

Keywords

total hip arthroplasty, ceramic-on-ceramic, total hip replacement

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.

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale- Change from baseline at 1 yearChange from baseline at 1 yearVisual 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.
Harris Hip Score- Change from baseline at 1 yearChange from baseline at 1 yearHarris 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.
Oxford Hip Score- Change from baseline at 1 yearChange from baseline at 1 yearOxford 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.
Radiologic analysis- Change from baseline at 1 yearChange from baseline at 1 yearRadiologic analysis helps observe the existence of radiolucent lines, which can be analyzed to determine if implant loosening occurs.

Countries

Taiwan

Contacts

Primary ContactYang-Chen Chou
ycchou00058@gmail.com886-5-532-3911

Outcome results

None listed

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