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NCT04594564 Clinical Trial

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

Osteoarthritis, Hip Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04594564
Other study ID # Delta TT cup
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date December 31, 2023

Study information
Verified date October 2022
Source Seoul National University Hospital
Contact Young-Kyun Lee
Phone 82-31-787-7204
Email ykleemd@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will evaluate clinical outcome on patients who undergo ceramic on ceramic (CoC) bearing total hip arthroplasty (THA) using Delta TT cup.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 270
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Total hip arthroplasty with Delta TT cup
Total hip arthroplasty using Delta TT cup and ceramic bearings

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi-do

Sponsors (2)
Lead Sponsor Collaborator
Seoul National University Hospital LIMA Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other Range of motion Change of range of motion after THA 24 months
Other Survivorship of implant Survival rate of prosthesis 24 months
Primary Squeaking Rate of any noise after THA 6 weeks
Primary Squeaking Rate of any noise after THA 3 months
Primary Squeaking Rate of any noise after THA 6 months
Primary Squeaking Rate of any noise after THA 9 months
Primary Squeaking Rate of any noise after THA 12 months
Primary Squeaking Rate of any noise after THA 24 months
Secondary Dislocation Dislocation rate after THA 6 weeks
Secondary Dislocation Dislocation rate after THA 3 months
Secondary Dislocation Dislocation rate after THA 6 months
Secondary Dislocation Dislocation rate after THA 9 months
Secondary Dislocation Dislocation rate after THA 12 months
Secondary Dislocation Dislocation rate after THA 24 months
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