Squeaking in Ceramic-on-Ceramic Total Hip Arthroplasty Using Delta TT Cup

October 24, 2022 updated by: Young-Kyun Lee, Seoul National University Hospital
This study will evaluate clinical outcome on patients who undergo ceramic on ceramic (CoC) bearing total hip arthroplasty (THA) using Delta TT cup.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate clinical outcome on patients who undergo ceramic on ceramic (CoC) bearing total hip arthroplasty (THA) using Delta TT cup. Specifically the study intends to address the following research topics:

  1. The incidence of squeaking after CoC THA using Delta TT cup.
  2. The dislocation rate and survival rate of CoC THA using Delta TT cup.

Study Type

Observational

Enrollment (Anticipated)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Those who undergo THA for their advanced hip disease.

Description

Inclusion Criteria:

  • Older than 18 years old
  • Non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis
  • Rheumatoid arthritis
  • Post-traumatic arthritis
  • Fractures of femoral neck

Exclusion Criteria:

  • Local or systemic infection
  • Septicaemia
  • Persistent acute or chronic osteomyelitis
  • Confirmed nerve or muscle lesion compromising hip joint function
  • Unstable medical illness
  • Rapidly progressive neurological disease

Study Plan

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

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Squeaking
Time Frame: 6 weeks
Rate of any noise after THA
6 weeks
Squeaking
Time Frame: 3 months
Rate of any noise after THA
3 months
Squeaking
Time Frame: 6 months
Rate of any noise after THA
6 months
Squeaking
Time Frame: 9 months
Rate of any noise after THA
9 months
Squeaking
Time Frame: 12 months
Rate of any noise after THA
12 months
Squeaking
Time Frame: 24 months
Rate of any noise after THA
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dislocation
Time Frame: 6 weeks
Dislocation rate after THA
6 weeks
Dislocation
Time Frame: 3 months
Dislocation rate after THA
3 months
Dislocation
Time Frame: 6 months
Dislocation rate after THA
6 months
Dislocation
Time Frame: 9 months
Dislocation rate after THA
9 months
Dislocation
Time Frame: 12 months
Dislocation rate after THA
12 months
Dislocation
Time Frame: 24 months
Dislocation rate after THA
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion
Time Frame: 24 months
Change of range of motion after THA
24 months
Survivorship of implant
Time Frame: 24 months
Survival rate of prosthesis
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

LIMA Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (ACTUAL)

October 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Delta TT cup

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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