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

• Conditions: Total Hip Arthroplasty; Total Hip Replacement

• Registration Number: NCT04256291
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-02-03
• Last Update Submitted: 2020-02-03
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Department of Orthopaedics- National Taiwan University Hospital Yunlin Branch; 🇨🇳 Douliu, Taiwan