Completed

Comparison of Ceramic-on-Ceramic and Ceramic-on-Polyethylene Bearings in Cementless Total Hip Arthroplasty

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Study Aim

This study aims to compare the effectiveness of Ceramic-on-Ceramic and Ceramic-on-Polyethylene Bearings in Cementless Total Hip Arthroplasty, by evaluating the Harris hip score before and after the intervention, and at the final follow-up.

What is being tested

Ceramic on Ceramic bearing

+ Ceramic on Highly crosslinked polyethylene bearing

Procedure
Who is being recruted

Arthritis+7

+ Bone Diseases

+ Joint Diseases

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 1998
See protocol details

Summary

Principal SponsorEwha Womans University
Last updated: March 7, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1998

Actual date on which the first participant was enrolled.

This study focuses on comparing two types of bearings used in cementless total hip replacement surgery: ceramic-on-ceramic and ceramic-on-highly-cross-linked polyethylene. The study is designed for young and active patients who are in need of this surgical intervention. The main goal is to see which of these two types of bearings leads to better results in terms of both physical function and imaging tests, as well as to evaluate the occurrence of a condition called osteolysis, which is the destruction or disappearance of bone tissue.

NCT01806766
Principal SponsorEwha Womans University
Last updated: March 7, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisBone DiseasesJoint DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesRheumatic DiseasesPathological Conditions, Signs and SymptomsOsteoarthritisOsteonecrosis

Criteria

3 inclusion criteria required to participate
Avascular necrosis of femoral head
Primary hip osteoarthritis
Secondary hip osteoarthritis
1 exclusion criteria prevent from participating
Previous surgical history of hip

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Ceramic on Ceramic bearing coupled side of a single patient undergoing bilateral total hip arthroplasty

Group II

Active Comparator
Ceramic on HIghly crosslinked polyethylene bearing coupled side of a single patient undergoing bilateral total hip arthroplasty

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Ewha Womans University Mokdong Hospital

Seoul, South KoreaOpen Ewha Womans University Mokdong Hospital in Google Maps
CompletedOne Study Center