Skip to main content
Clinical Trials/NCT04256291
NCT04256291
Unknown
Not Applicable

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

National Taiwan University Hospital1 site in 1 country160 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Hip Arthroplasty
Sponsor
National Taiwan University Hospital
Enrollment
160
Locations
1
Primary Endpoint
Visual Analogue Scale- Change from baseline at 1 year
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
July 31, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Visual Analogue Scale- Change from baseline at 1 year

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials