OsteonecrosisPhase 4NCT01806766
Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings
A Phase 4 study testing Ceramic on Ceramic bearing and Ceramic on Highly crosslinked polyethylene bearing in people with Osteonecrosis and Osteoarthritis, run by Ewha Womans University at 1 site in South Korea.
Trial summary
The purpose of this prospective, randomized study was to compare the clinical and radiographic results and the prevalence of osteolysis of the cementless total hip arthroplasty with an alumina-on-alumina bearings one side and alumina-on-highly cross-linked polyethylene bearings on the other side in the young and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteonecrosis, Osteoarthritis
- What is being tested?
- Ceramic on Ceramic bearing and Ceramic on Highly crosslinked polyethylene bearing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 1998to Dec 2012
- Phase
- Phase 4
- 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
Who may be able to join
- Primary hip osteoarthritis
- Secondary hip osteoarthritis
- Avascular necrosis of femoral head
Who cannot join
- Previous surgical history of hip
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings in Primary Cementless Total Hip Arthroplasty in the Same Patients
The purpose of this prospective, randomized study was to compare the clinical and radiographic results and the prevalence of osteolysis of the cementless total hip arthroplasty with an alumina-on-alumina bearings one side and alumina-on-highly cross-linked polyethylene bearings on the other side in the young and active patients.
- Conditions
- Osteonecrosis, Osteoarthritis
- Being tested
- Ceramic on Ceramic bearing, Ceramic on Highly crosslinked polyethylene bearing
- Keywords
- cementless total hip arthroplasty, ceramic on ceramic bearing, ceramic on highly cross linked polyethylene, young patient
- Medical subject headings
- Osteonecrosis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceramic on Ceramic bearingProcedure or surgery
cementless Total Hip Arthroplasty with Ceramic on ceramic bearing
Ceramic on Highly crosslinked polyethylene bearingProcedure or surgery
Cementless Total Hip Arthroplasty with Ceramic on Highly crosslinked polyethylene bearing
| Study group | Role | What they receive |
|---|---|---|
| Ceramic on Ceramic | Active comparator | Ceramic on Ceramic bearing coupled side of a single patient undergoing bilateral total hip arthroplasty Receives: Procedure: Ceramic on Ceramic bearing |
| Ceramic on HXPE | Active comparator | Ceramic on HIghly crosslinked polyethylene bearing coupled side of a single patient undergoing bilateral total hip arthroplasty Receives: Procedure: Ceramic on Highly crosslinked polyethylene bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris hip score
Comparing harris hip score before and after the intervention, and at the final follow-up, between two sides.
Measured: Pre-op, last follow-up(11-13 years)
Secondary outcomes (1)
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
WOMAC index before, and after the intervention, and between sides at the last follow-up
Measured: preop, last follow-up(11-13 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startJan 1998
- Primary completionJan 2000
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteonecrosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Hoo Kim, Ewha Womans University
- Investigators
- Young-Hoo Kim, MD, Study director, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806766
- Sponsor's protocol ID
- XPECCC
- Status last verified
- Mar 2013
- First submitted
- 5 Mar 2013
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings in Primary Cementless Total Hip Arthroplasty in the Same Patients
- ClinicalTrials.gov ID
- NCT01806766
- Acronym / sponsor ID
- XPECCC
- Conditions
- Osteonecrosis, Osteoarthritis
- Keywords
- cementless total hip arthroplasty, ceramic on ceramic bearing, ceramic on highly cross linked polyethylene, young patient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Jan 2000 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Mar 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.
The purpose of this prospective, randomized study was to compare the clinical and radiographic results and the prevalence of osteolysis of the cementless total hip arthroplasty with an alumina-on-alumina bearings one side and alumina-on-highly cross-linked polyethylene bearings on the other side in the young and active patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceramic on Ceramic | Active comparator | Procedure: Ceramic on Ceramic bearingCeramic on Ceramic bearing coupled side of a single patient undergoing bilateral total hip arthroplasty |
| Ceramic on HXPE | Active comparator | Procedure: Ceramic on Highly crosslinked polyethylene bearingCeramic on HIghly crosslinked polyethylene bearing coupled side of a single patient undergoing bilateral total hip arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary hip osteoarthritis
- Secondary hip osteoarthritis
- Avascular necrosis of femoral head
Key exclusion criteria (1 listed)
- Previous surgical history of hip
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 |
|---|---|---|
| Ceramic on Ceramic bearingcementless Total Hip Arthroplasty with Ceramic on ceramic bearing | Procedure or surgery | Ceramic on Ceramic |
| Ceramic on Highly crosslinked polyethylene bearingCementless Total Hip Arthroplasty with Ceramic on Highly crosslinked polyethylene bearing | Procedure or surgery | Ceramic on HXPE |
Primary outcome
Harris hip score
Time frame: Pre-op, last follow-up(11-13 years)
Comparing harris hip score before and after the intervention, and at the final follow-up, between two sides.
1 secondary outcome
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Time frame: preop, last follow-up(11-13 years)
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 7 Mar 2013.
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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-Hoo Kim, MD study director
Ewha Womans University Mokdong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceramic on Ceramic bearing and Ceramic on Highly crosslinked polyethylene bearing in people with Osteonecrosis and Osteoarthritis, run by Ewha Womans University 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 3 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: finished, as of the sponsor's last update on 7 Mar 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Harris hip score (time frame: Pre-op, last follow-up(11-13 years)). 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 7 Mar 2013.