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

NCT04256291 | Unknown

• 1 other identifier: 201807006RINA
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty; Total Hip Replacement

Keywords

total hip arthroplasty; ceramic-on-ceramic; total hip replacement

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who has received ceramic-on-ceramic total hip replacement after the year of 2013.

You may not qualify if:

• Patients who are unable or unwilling to return for follow-up
• Patients who have deep periprosthetic joint infection
• Patients who are diagnosed skeletal dysplasia
• Patients who suffer from mental disorders

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Orthopaedics- National Taiwan University Hospital Yunlin Branch

Douliu, Taiwan

RECRUITING

Study Officials

• Yang-Chen Chou

  National Taiwan University Hospital

  STUDY CHAIR

• Chen-Chiang Lin

  National Taiwan University Hospital

  STUDY DIRECTOR

Central Study Contacts

Yang-Chen Chou

CONTACT

886-5-532-3911; ycchou00058@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: August 1, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

TW (1)