Arthroplasty, Replacement, HipPhase 4THANCT01098604
The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty
A Phase 4 study testing 32mm ceramic head group and 28mm ceramic head group in people with Arthroplasty, Replacement, Hip, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
It has been postulated that use of a larger femoral head could reduce the risk of dislocation after total hip arthroplasty, but only limited clinical data have been presented in third generation alumina bearings. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- 32mm ceramic head group and 28mm ceramic head group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2006to Dec 2009
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteonecrosis of femoral head
- primary or secondary osteoarthritis of the hips
- femoral neck fracture
Who cannot join
- previous hemi- or total hip arthroplasty
- highly dislocated or severe ankylosed hip
- patients who are considered potentially unreliable or who may not reliably attend study visits
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul national University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty: A Randomized Clinical Trial
It has been postulated that use of a larger femoral head could reduce the risk of dislocation after total hip arthroplasty, but only limited clinical data have been presented in third generation alumina bearings.
The purpose of this study is to evaluate the effect of femoral head size for total hip arthroplasty using third generation alumina bearings on the joint stability and clinical results.
The investigators hypothesized that larger ceramic head group has a similar rate of dislocation and clinical results in smaller ceramic head group.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- 32mm ceramic head group, 28mm ceramic head group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
32mm ceramic head groupDevice
we performed THA using 32mm ceramic head in this group.
28mm ceramic head groupDevice
we performed THA using 28mm ceramic head in this group.
| Study group | Role | What they receive |
|---|---|---|
| 32mm ceramic head group | Active comparator | patients performed with THA using 32mm ceramic head Receives: Device: 32mm ceramic head group |
| 28mm ceramic head group | Active comparator | patients performed with THA using 28mm ceramic head Receives: Device: 28mm ceramic head group |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of dislocation in each head size
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
Measured: 6 weeks
rate of dislocation in each head size
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
Measured: 3 months
rate of dislocation in each head size
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
Measured: 6 months
rate of dislocation in each head size
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
Measured: 9 months
rate of dislocation in each head size
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
Measured: 12 months
rate of dislocation in each head size
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
Measured: 24 months
Secondary outcomes (6)
clinical results using Harris Hip Score
to compare the clinical results such as pain, function, range of motion between both groups.
Measured: 6 weeks
clinical results using Harris Hip Score
to compare the clinical results such as pain, function, range of motion between both groups.
Measured: 3 months
clinical results using Harris Hip Score
to compare the clinical results such as pain, function, range of motion between both groups.
Measured: 6 months
clinical results using Harris Hip Score
to compare the clinical results such as pain, function, range of motion between both groups.
Measured: 9 months
clinical results using Harris Hip Score
to compare the clinical results such as pain, function, range of motion between both groups.
Measured: 12 months
clinical results using Harris Hip Score
to compare the clinical results such as pain, function, range of motion between both groups.
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 posted5 Apr 2010 (estimated)
- Study startMay 2006
- Primary completionNov 2007
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kyung-Hoi Koo, professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098604
- Sponsor's protocol ID
- SNU 08-01
- Acronym
- THA
- Status last verified
- Mar 2010
- First submitted
- 1 Apr 2010
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01098604
- Acronym / sponsor ID
- THA / SNU 08-01
- Conditions
- Arthroplasty, Replacement, Hip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Apr 2010 (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.
It has been postulated that use of a larger femoral head could reduce the risk of dislocation after total hip arthroplasty, but only limited clinical data have been presented in third generation alumina bearings.
The purpose of this study is to evaluate the effect of femoral head size for total hip arthroplasty using third generation alumina bearings on the joint stability and clinical results.
The investigators hypothesized that larger ceramic head group has a similar rate of dislocation and clinical results in smaller ceramic head group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 32mm ceramic head group | Active comparator | Device: 32mm ceramic head grouppatients performed with THA using 32mm ceramic head |
| 28mm ceramic head group | Active comparator | Device: 28mm ceramic head grouppatients performed with THA using 28mm ceramic head |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- osteonecrosis of femoral head
- primary or secondary osteoarthritis of the hips
- femoral neck fracture
Key exclusion criteria (3 listed)
- previous hemi- or total hip arthroplasty
- highly dislocated or severe ankylosed hip
- patients who are considered potentially unreliable or who may not reliably attend study visits
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 |
|---|---|---|
| 32mm ceramic head groupwe performed THA using 32mm ceramic head in this group. | Device | 32mm ceramic head group |
| 28mm ceramic head groupwe performed THA using 28mm ceramic head in this group. | Device | 28mm ceramic head group |
Primary outcome
rate of dislocation in each head size
Time frame: 6 weeks
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
rate of dislocation in each head size
Time frame: 3 months
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
rate of dislocation in each head size
Time frame: 6 months
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
rate of dislocation in each head size
Time frame: 9 months
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
rate of dislocation in each head size
Time frame: 12 months
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
rate of dislocation in each head size
Time frame: 24 months
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
6 secondary outcomes
clinical results using Harris Hip Score
Time frame: 6 weeks
clinical results using Harris Hip Score
Time frame: 3 months
clinical results using Harris Hip Score
Time frame: 6 months
clinical results using Harris Hip Score
Time frame: 9 months
clinical results using Harris Hip Score
Time frame: 12 months
clinical results using Harris Hip Score
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 20 Mar 2014.
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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
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 32mm ceramic head group and 28mm ceramic head group in people with Arthroplasty, Replacement, Hip, run by Seoul National University Bundang 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 3 inclusion and 3 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 20 Mar 2014. 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?
rate of dislocation in each head size (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 20 Mar 2014.