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

Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04256291
• Other study ID #: 201807006RINA
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: January 2020
• Source: National Taiwan University Hospital
• Contact: Yang-Chen Chou
• Phone: 886-5-532-3911
• Email: ycchou00058[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Arthroplasty
• Total Hip Replacement

Locations

Country	Name	City	State
Taiwan	Department of Orthopaedics- National Taiwan University Hospital Yunlin Branch	Douliu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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