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

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.

Study Overview

• Status: Unknown
• Conditions: Total Hip Replacement; Total Hip Arthroplasty

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Yang-Chen Chou; Phone Number: 5886 886-5-532-3911; Email: ycchou00058@gmail.com

Study Locations

• Taiwan
  • Douliu, Taiwan
    • Recruiting
    • Department of Orthopaedics- National Taiwan University Hospital Yunlin Branch
    • Contact: Yang-Chen Chou; Phone Number: 5886 886-5-5323911; Email: ycchou00058@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who has received ceramic-on-ceramic total hip replacement after the year of 2013 at National Taiwan University Hospital Yunlin Branch.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale- 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.	Change from baseline at 1 year
Harris Hip Score- 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.	Change from baseline at 1 year
Oxford Hip Score- 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.	Change from baseline at 1 year
Radiologic analysis- 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.	Change from baseline at 1 year

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: total hip arthroplasty; total hip replacement; ceramic-on-ceramic
• Other Study ID Numbers: 201807006RINA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No