Advanced Hip DiseaseNCT01838096
Alumina Matrix Composite Ceramic Bearing Total Hip Arthroplasty in Patients Younger Than 30 Years
A study testing THA using 4th generation CoC in people with Advanced Hip Disease, run by Seoul National University Bundang Hospital.
Trial summary
This study will evaluate clinical outcome on patients who undergo cementless 4th generation ceramic (BIOLOX®delta, CeramTec GmbH, Plochingen, Germany) on ceramic (CoC) bearing total hip aArthroplasty ("THA") in patients younger than 30 years. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Advanced Hip Disease
- What is being tested?
- THA using 4th generation CoC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Nov 2023
- Phase
- Interventional
- 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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- younger than 30 years
- advanced hip disease
Who cannot join
- older than 30 years
About this study
This study will evaluate clinical outcome on patients who undergo cementless 4th generation ceramic (BIOLOX®delta, CeramTec GmbH, Plochingen, Germany) on ceramic (CoC) bearing total hip aArthroplasty ("THA") in patients younger than 30 years.
- Conditions
- Advanced Hip Disease
- Being tested
- THA using 4th generation CoC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THA using 4th generation CoCDevice
| Study group | Role | What they receive |
|---|---|---|
| THA | Experimental | Not described Receives: Device: THA using 4th generation CoC |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate of 4th generation ceramic-on-ceramic THA
survival rate of 4th generation ceramic-on-ceramic THA end point for best senario ; any reoperation end point for moderate senario ; loosening end point for worst senario ; osteolysis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startMar 2008
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Hip DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CeramTec GmbH
- Responsible party
- Principal investigator, Kyung-Hoi Koo, Seoul National University Bundang Hospital
- Investigators
- Kyung-Hoi Koo, Professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838096
- Sponsor's protocol ID
- Cera-001
- Status last verified
- Jan 2022
- First submitted
- 15 Apr 2013
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee YK, Kim KC, Yoon BH, Kim TY, Ha YC, Koo KH. Cementless total hip arthroplasty with delta-on-delta ceramic bearing in patients younger than 30 years. Hip Int. 2021 Mar;31(2):181-185. doi: 10.1177/1120700019889592. Epub 2019 Nov 25.
PubMed 31766869
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alumina Matrix Composite Ceramic Bearing Total Hip Arthroplasty in Patients Younger Than 30 Years
- ClinicalTrials.gov ID
- NCT01838096
- Acronym / sponsor ID
- Cera-001
- Conditions
- Advanced Hip Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- CeramTec GmbH
- Study start
- Mar 2008
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 23 Apr 2013 (estimated)
- 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 cementless 4th generation ceramic (BIOLOX®delta, CeramTec GmbH, Plochingen, Germany) on ceramic (CoC) bearing total hip aArthroplasty ("THA") in patients younger than 30 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THA | Experimental | Device: THA using 4th generation CoC |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- younger than 30 years
- advanced hip disease
Key exclusion criteria (1 listed)
- older than 30 years
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 |
|---|---|---|
| THA using 4th generation CoC | Device | THA |
Primary outcome
survival rate of 4th generation ceramic-on-ceramic THA
Time frame: 5 years
survival rate of 4th generation ceramic-on-ceramic THA end point for best senario ; any reoperation end point for moderate senario ; loosening end point for worst senario ; osteolysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Derived from this study: PubMed 31766869Lee YK, Kim KC, Yoon BH, Kim TY, Ha YC, Koo KH. Cementless total hip arthroplasty with delta-on-delta ceramic bearing in patients younger than 30 years. Hip Int. 2021 Mar;31(2):181-185. doi: 10.1177/1120700019889592. Epub 2019 Nov 25.
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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.
Kyung-Hoi Koo, Professor principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing THA using 4th generation CoC in people with Advanced Hip Disease, run by Seoul National University Bundang Hospital.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
survival rate of 4th generation ceramic-on-ceramic THA (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01838096, which also lists 1 linked publication.
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 2 Feb 2022.