Osteoarthritis, HipNCT04594564
Squeaking in Ceramic-on-Ceramic Total Hip Arthroplasty Using Delta TT Cup
An observational study of Osteoarthritis, Hip and Osteonecrosis of Femoral Head, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Osteonecrosis of Femoral Head, Femoral Neck Fractures
- What is being tested?
- Total hip arthroplasty with Delta TT cup
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those who undergo THA for their advanced hip disease.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
This study will evaluate clinical outcome on patients who undergo ceramic on ceramic (CoC) bearing total hip arthroplasty (THA) using Delta TT cup.
Read the 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:
- The incidence of squeaking after CoC THA using Delta TT cup.
- The dislocation rate and survival rate of CoC THA using Delta TT cup.
- Conditions
- Osteoarthritis, Hip, Osteonecrosis of Femoral Head, Femoral Neck Fractures, Rheumatoid Arthritis of Hip, Posttraumatic Arthropathy
- Being tested
- Total hip arthroplasty with Delta TT cup
- Keywords
- Total hip arhtroplasty, Squeaking, Dislocation, Ceramic bearings
- Medical subject headings
- Osteoarthritis, Hip, Femur Head Necrosis, Femoral Neck Fractures, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplasty with Delta TT cupProcedure or surgery
Total hip arthroplasty using Delta TT cup and ceramic bearings
What is being measured
The primary outcome is the main question the study is designed to answer.
Squeaking
Rate of any noise after THA
Measured: 6 weeks
Squeaking
Rate of any noise after THA
Measured: 3 months
Squeaking
Rate of any noise after THA
Measured: 6 months
Squeaking
Rate of any noise after THA
Measured: 9 months
Squeaking
Rate of any noise after THA
Measured: 12 months
Squeaking
Rate of any noise after THA
Measured: 24 months
Secondary outcomes (6)
Dislocation
Dislocation rate after THA
Measured: 6 weeks
Dislocation
Dislocation rate after THA
Measured: 3 months
Dislocation
Dislocation rate after THA
Measured: 6 months
Dislocation
Dislocation rate after THA
Measured: 9 months
Dislocation
Dislocation rate after THA
Measured: 12 months
Dislocation
Dislocation rate after THA
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LIMA Korea
- Responsible party
- Principal investigator, Young-Kyun Lee, Seoul National University Hospital
- Investigators
- Young-Kyun Lee, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594564
- Sponsor's protocol ID
- Delta TT cup
- Status last verified
- May 2025
- First submitted
- 13 Oct 2020
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Squeaking in Ceramic-on-Ceramic Total Hip Arthroplasty Using Delta TT Cup
- ClinicalTrials.gov ID
- NCT04594564
- Acronym / sponsor ID
- Delta TT cup
- Conditions
- Osteoarthritis, Hip, Osteonecrosis of Femoral Head, Femoral Neck Fractures, Rheumatoid Arthritis of Hip, Posttraumatic Arthropathy
- Keywords
- Total hip arhtroplasty, Squeaking, Dislocation, Ceramic bearings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- LIMA Korea
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate clinical outcome on patients who undergo ceramic on ceramic (CoC) bearing total hip arthroplasty (THA) using Delta TT cup.
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:
- The incidence of squeaking after CoC THA using Delta TT cup.
- The dislocation rate and survival rate of CoC THA using Delta TT cup.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those who undergo THA for their advanced hip disease.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Local or systemic infection
- Septicaemia
- Persistent acute or chronic osteomyelitis
- Confirmed nerve or muscle lesion compromising hip joint function
- Unstable medical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total hip arthroplasty with Delta TT cupTotal hip arthroplasty using Delta TT cup and ceramic bearings | Procedure or surgery | – |
Primary outcome
Squeaking
Time frame: 6 weeks
Rate of any noise after THA
Squeaking
Time frame: 3 months
Rate of any noise after THA
Squeaking
Time frame: 6 months
Rate of any noise after THA
Squeaking
Time frame: 9 months
Rate of any noise after THA
Squeaking
Time frame: 12 months
Rate of any noise after THA
Squeaking
Time frame: 24 months
Rate of any noise after THA
6 secondary outcomes
Dislocation
Time frame: 6 weeks
Dislocation
Time frame: 3 months
Dislocation
Time frame: 6 months
Dislocation
Time frame: 9 months
Dislocation
Time frame: 12 months
Dislocation
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Kyun Lee principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip and Osteonecrosis of Femoral Head, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Squeaking (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.